Trial Outcomes & Findings for Hormonal Intervention for the Treatment in Veterans With COVID-19 Requiring Hospitalization (NCT NCT04397718)
NCT ID: NCT04397718
Last Updated: 2022-06-06
Results Overview
Number of Patients who died, had a ongoing need for hospitalization, or was placed on mechanical ventilation at Day 15.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
96 participants
Primary outcome timeframe
15 days
Results posted on
2022-06-06
Participant Flow
Participant milestones
| Measure |
Placebo + BSC
No active, only placebo (2 - prefilled syringes containing 3 ml of 0.9% saline) plus best supportive care.
Saline: 09% Saline
|
Degarelix + BSC
Active Degarelix (2 - prefilled syringes containing 3 ml of reconstituted Degarelix concentrated to 40mg/ml) plus best supportive care.
Degarelix: Degarelix is an FDA-approved drug for prostate cancer
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
62
|
|
Overall Study
COMPLETED
|
27
|
47
|
|
Overall Study
NOT COMPLETED
|
7
|
15
|
Reasons for withdrawal
| Measure |
Placebo + BSC
No active, only placebo (2 - prefilled syringes containing 3 ml of 0.9% saline) plus best supportive care.
Saline: 09% Saline
|
Degarelix + BSC
Active Degarelix (2 - prefilled syringes containing 3 ml of reconstituted Degarelix concentrated to 40mg/ml) plus best supportive care.
Degarelix: Degarelix is an FDA-approved drug for prostate cancer
|
|---|---|---|
|
Overall Study
Death
|
7
|
11
|
|
Overall Study
Lost to Follow-up
|
0
|
4
|
Baseline Characteristics
Hormonal Intervention for the Treatment in Veterans With COVID-19 Requiring Hospitalization
Baseline characteristics by cohort
| Measure |
Placebo + BSC
n=34 Participants
No active, only placebo (2 - prefilled syringes containing 3 ml of 0.9% saline) plus best supportive care.
Saline: 09% Saline
|
Degarelix + BSC
n=62 Participants
Active Degarelix (2 - prefilled syringes containing 3 ml of reconstituted Degarelix concentrated to 40mg/ml) plus best supportive care.
Degarelix: Degarelix is an FDA-approved drug for prostate cancer
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.1 years
STANDARD_DEVIATION 8.18 • n=5 Participants
|
68.8 years
STANDARD_DEVIATION 8.6 • n=7 Participants
|
68.5 years
STANDARD_DEVIATION 8.42 • 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
|
34 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
45 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
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 15 daysNumber of Patients who died, had a ongoing need for hospitalization, or was placed on mechanical ventilation at Day 15.
Outcome measures
| Measure |
Placebo + BSC
n=34 Participants
No active, only placebo (2 - prefilled syringes containing 3 ml of 0.9% saline) plus best supportive care.
Saline: 09% Saline
|
Degarelix + BSC
n=62 Participants
Active Degarelix (2 - prefilled syringes containing 3 ml of reconstituted Degarelix concentrated to 40mg/ml) plus best supportive care.
Degarelix: Degarelix is an FDA-approved drug for prostate cancer
|
|---|---|---|
|
Composite of Mortality, Ongoing Need for Hospitalization, or Mechanical Ventilation at Day 15
|
9 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Through discharge (an average of 8 days with a maximum of 2.5 months)Time to clinical improvement as defined by a decline of 2 categories or more from the baseline modified 7-category ordinal scale of clinical status of hospitalized influenza patients or hospital discharge, whichever comes first. Participants whose condition worsened, who died, or who withdrew from the study without clinical improvement were censored. The 7-categories were defined as: 1: Not hospitalized with resumption of normal activities; 2: Not hospitalized, but unable to resume normal activities; 3: Hospitalization, not requiring supplemental oxygen; 4: Hospitalization, requiring supplemental oxygen; 5: Hospitalization, requiring nasal high-flow oxygen therapy and/or noninvasive mechanical ventilation; 6: Hospitalization, requiring extracorporeal membrane oxygenation and/or invasive mechanical ventilation; 7: Death.
Outcome measures
| Measure |
Placebo + BSC
n=34 Participants
No active, only placebo (2 - prefilled syringes containing 3 ml of 0.9% saline) plus best supportive care.
Saline: 09% Saline
|
Degarelix + BSC
n=62 Participants
Active Degarelix (2 - prefilled syringes containing 3 ml of reconstituted Degarelix concentrated to 40mg/ml) plus best supportive care.
Degarelix: Degarelix is an FDA-approved drug for prostate cancer
|
|---|---|---|
|
Time to Clinical Improvement
|
5.50 Days
Interval 5.0 to 15.0
|
7.00 Days
Interval 4.0 to 15.0
|
SECONDARY outcome
Timeframe: Through discharge (an average of 8 days with a maximum of 2.5 months)Number of patients who died during their hospital stay
Outcome measures
| Measure |
Placebo + BSC
n=34 Participants
No active, only placebo (2 - prefilled syringes containing 3 ml of 0.9% saline) plus best supportive care.
Saline: 09% Saline
|
Degarelix + BSC
n=62 Participants
Active Degarelix (2 - prefilled syringes containing 3 ml of reconstituted Degarelix concentrated to 40mg/ml) plus best supportive care.
Degarelix: Degarelix is an FDA-approved drug for prostate cancer
|
|---|---|---|
|
Inpatient Mortality
|
6 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Through discharge (an average of 8 days with a maximum of 2.5 months)Population: Patients who died during the hospital stay were excluded.
Length of hospital stay (randomization to discharge)
Outcome measures
| Measure |
Placebo + BSC
n=28 Participants
No active, only placebo (2 - prefilled syringes containing 3 ml of 0.9% saline) plus best supportive care.
Saline: 09% Saline
|
Degarelix + BSC
n=51 Participants
Active Degarelix (2 - prefilled syringes containing 3 ml of reconstituted Degarelix concentrated to 40mg/ml) plus best supportive care.
Degarelix: Degarelix is an FDA-approved drug for prostate cancer
|
|---|---|---|
|
Duration of Hospitalization
|
5.00 Days
Interval 5.0 to 8.0
|
6.00 Days
Interval 3.0 to 9.0
|
SECONDARY outcome
Timeframe: Through discharge (an average of 8 days with a maximum of 2.5 months)Population: Patients who died and who were not on mechanical ventilation prior to death were excluded (N=4).
Length of time on mechanical ventilation. Length of mechanical ventilation imputed to maximum length (50 days) for patients who died on mechanical ventilation or who were on mechanical ventilation, but date removed was unknown. Length of mechanical ventilation imputed to 0 for patients never on mechanical ventilation.
Outcome measures
| Measure |
Placebo + BSC
n=33 Participants
No active, only placebo (2 - prefilled syringes containing 3 ml of 0.9% saline) plus best supportive care.
Saline: 09% Saline
|
Degarelix + BSC
n=59 Participants
Active Degarelix (2 - prefilled syringes containing 3 ml of reconstituted Degarelix concentrated to 40mg/ml) plus best supportive care.
Degarelix: Degarelix is an FDA-approved drug for prostate cancer
|
|---|---|---|
|
Duration of Intubation
|
0.00 Days
Interval 0.0 to 0.0
|
0.00 Days
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Through discharge (an average of 8 days with a maximum of 2.5 months)Population: Patients with a fever (temperature greater than or equal to 37.5 degrees Celsius) at baseline.
Length of time for temperature to be less than \< 37.5 degree Celsius for 48 hours
Outcome measures
| Measure |
Placebo + BSC
n=7 Participants
No active, only placebo (2 - prefilled syringes containing 3 ml of 0.9% saline) plus best supportive care.
Saline: 09% Saline
|
Degarelix + BSC
n=17 Participants
Active Degarelix (2 - prefilled syringes containing 3 ml of reconstituted Degarelix concentrated to 40mg/ml) plus best supportive care.
Degarelix: Degarelix is an FDA-approved drug for prostate cancer
|
|---|---|---|
|
Time to Normalization of Temperature.
|
5.00 Days
Interval 2.0 to 18.0
|
3.00 Days
Interval 1.0 to 3.0
|
SECONDARY outcome
Timeframe: Through discharge (an average of 8 days with a maximum of 2.5 months)Maximum severity score on the modified 7-category ordinal scale of clinical status of hospitalized influenza patients. The 7-categories were defined as: 1: Not hospitalized with resumption of normal activities; 2: Not hospitalized, but unable to resume normal activities; 3: Hospitalization, not requiring supplemental oxygen; 4: Hospitalization, requiring supplemental oxygen; 5: Hospitalization, requiring nasal high-flow oxygen therapy and/or noninvasive mechanical ventilation; 6: Hospitalization, requiring extracorporeal membrane oxygenation and/or invasive mechanical ventilation; 7: Death.
Outcome measures
| Measure |
Placebo + BSC
n=34 Participants
No active, only placebo (2 - prefilled syringes containing 3 ml of 0.9% saline) plus best supportive care.
Saline: 09% Saline
|
Degarelix + BSC
n=62 Participants
Active Degarelix (2 - prefilled syringes containing 3 ml of reconstituted Degarelix concentrated to 40mg/ml) plus best supportive care.
Degarelix: Degarelix is an FDA-approved drug for prostate cancer
|
|---|---|---|
|
Maximum Severity of COVID19 Illness.
Hospitalization, not requiring supplemental oxygen
|
4 Participants
|
8 Participants
|
|
Maximum Severity of COVID19 Illness.
Hospitalization, requiring supplemental oxygen
|
20 Participants
|
26 Participants
|
|
Maximum Severity of COVID19 Illness.
Hospitalization,req. nasal high-flow oxygen therapy &/or noninvasive mechanical ventilation
|
4 Participants
|
14 Participants
|
|
Maximum Severity of COVID19 Illness.
Hospitalization, req. extracorporeal membrane oxygenation &/or invasive mech. ventilation
|
0 Participants
|
3 Participants
|
|
Maximum Severity of COVID19 Illness.
Death
|
6 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 30 daysNumber of Patients who died, had a ongoing need for hospitalization, or was placed on mechanical ventilation at Day 30.
Outcome measures
| Measure |
Placebo + BSC
n=34 Participants
No active, only placebo (2 - prefilled syringes containing 3 ml of 0.9% saline) plus best supportive care.
Saline: 09% Saline
|
Degarelix + BSC
n=62 Participants
Active Degarelix (2 - prefilled syringes containing 3 ml of reconstituted Degarelix concentrated to 40mg/ml) plus best supportive care.
Degarelix: Degarelix is an FDA-approved drug for prostate cancer
|
|---|---|---|
|
Composite of Mortality, Ongoing Need for Hospitalization, or Mechanical Ventilation at Day 30
|
7 Participants
|
15 Participants
|
Adverse Events
Placebo + BSC
Serious events: 11 serious events
Other events: 8 other events
Deaths: 7 deaths
Degarelix + BSC
Serious events: 19 serious events
Other events: 13 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
Placebo + BSC
n=34 participants at risk
No active, only placebo (2 - prefilled syringes containing 3 ml of 0.9% saline) plus best supportive care.
Saline: 09% Saline
|
Degarelix + BSC
n=62 participants at risk
Active Degarelix (2 - prefilled syringes containing 3 ml of reconstituted Degarelix concentrated to 40mg/ml) plus best supportive care.
Degarelix: Degarelix is an FDA-approved drug for prostate cancer
|
|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/34 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
1.6%
1/62 • Number of events 1 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/34 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
1.6%
1/62 • Number of events 1 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/34 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
1.6%
1/62 • Number of events 1 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/34 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
1.6%
1/62 • Number of events 1 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
|
Infections and infestations
COVID-19
|
0.00%
0/34 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
4.8%
3/62 • Number of events 3 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
|
Infections and infestations
COVID-19 pneumonia
|
11.8%
4/34 • Number of events 4 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
8.1%
5/62 • Number of events 5 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
|
Infections and infestations
Gastroenteritis
|
2.9%
1/34 • Number of events 1 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
0.00%
0/62 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
|
Infections and infestations
SARS-CoV-2 sepsis
|
0.00%
0/34 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
1.6%
1/62 • Number of events 1 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
|
Infections and infestations
Septic shock
|
0.00%
0/34 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
6.5%
4/62 • Number of events 4 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/34 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
1.6%
1/62 • Number of events 1 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.9%
1/34 • Number of events 1 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
1.6%
1/62 • Number of events 1 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/34 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
1.6%
1/62 • Number of events 1 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/34 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
3.2%
2/62 • Number of events 2 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/34 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
1.6%
1/62 • Number of events 1 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.9%
1/34 • Number of events 1 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
1.6%
1/62 • Number of events 1 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/34 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
1.6%
1/62 • Number of events 1 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.00%
0/34 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
1.6%
1/62 • Number of events 1 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/34 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
1.6%
1/62 • Number of events 1 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
11.8%
4/34 • Number of events 4 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
4.8%
3/62 • Number of events 3 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
|
Vascular disorders
Mouth haemorrhage
|
2.9%
1/34 • Number of events 1 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
0.00%
0/62 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
|
Vascular disorders
Orthostatic hypotension
|
2.9%
1/34 • Number of events 1 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
0.00%
0/62 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
Other adverse events
| Measure |
Placebo + BSC
n=34 participants at risk
No active, only placebo (2 - prefilled syringes containing 3 ml of 0.9% saline) plus best supportive care.
Saline: 09% Saline
|
Degarelix + BSC
n=62 participants at risk
Active Degarelix (2 - prefilled syringes containing 3 ml of reconstituted Degarelix concentrated to 40mg/ml) plus best supportive care.
Degarelix: Degarelix is an FDA-approved drug for prostate cancer
|
|---|---|---|
|
Cardiac disorders
Accelerated idioventricular rhythm
|
2.9%
1/34 • Number of events 1 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
0.00%
0/62 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/34 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
1.6%
1/62 • Number of events 1 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
|
Cardiac disorders
Atrial fibrillation
|
5.9%
2/34 • Number of events 2 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
1.6%
1/62 • Number of events 1 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/34 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
1.6%
1/62 • Number of events 1 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/34 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
1.6%
1/62 • Number of events 1 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/34 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
1.6%
1/62 • Number of events 1 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/34 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
3.2%
2/62 • Number of events 2 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
|
General disorders
Fatigue
|
0.00%
0/34 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
1.6%
1/62 • Number of events 1 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
|
General disorders
Peripheral swelling
|
2.9%
1/34 • Number of events 1 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
0.00%
0/62 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
|
General disorders
Pyrexia
|
0.00%
0/34 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
1.6%
1/62 • Number of events 1 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
|
Infections and infestations
Bacteraemia
|
2.9%
1/34 • Number of events 1 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
0.00%
0/62 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
|
Infections and infestations
Urinary tract infection
|
2.9%
1/34 • Number of events 1 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
1.6%
1/62 • Number of events 1 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
|
Injury, poisoning and procedural complications
Injection site pain
|
0.00%
0/34 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
1.6%
1/62 • Number of events 1 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
|
Injury, poisoning and procedural complications
Injection site reaction
|
0.00%
0/34 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
1.6%
1/62 • Number of events 1 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
|
Injury, poisoning and procedural complications
Tooth avulsion
|
2.9%
1/34 • Number of events 1 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
0.00%
0/62 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.9%
1/34 • Number of events 1 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
0.00%
0/62 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.9%
1/34 • Number of events 1 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
0.00%
0/62 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
|
Nervous system disorders
Seizure
|
0.00%
0/34 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
1.6%
1/62 • Number of events 1 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
|
Nervous system disorders
Syncope
|
2.9%
1/34 • Number of events 1 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
0.00%
0/62 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/34 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
1.6%
1/62 • Number of events 1 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
2.9%
1/34 • Number of events 1 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
0.00%
0/62 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.9%
1/34 • Number of events 1 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
0.00%
0/62 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/34 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
1.6%
1/62 • Number of events 2 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
|
Vascular disorders
Hot flush
|
0.00%
0/34 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
4.8%
3/62 • Number of events 3 • From randomization through day 60.
AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place