Trial Outcomes & Findings for Oral Testosterone for the Treatment of Hypogonadism in Males (NCT NCT02222558)
NCT ID: NCT02222558
Last Updated: 2016-05-30
Results Overview
Percentage of subjects with response to treatment within each period. Response to treatment was considered when Testosterone Cavg was within the physiological range of Testosterone concentration, i.e. 300 - 1050 ng/dL.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
Cavg from samples at Period 1: post dose hrs 0,1,2,3,4,5,6,8,12,16,24; Period 2: hrs 0,2,3,4,5,6,8,12,14,15,16,17,18,20,24; Period 3 BID: hrs 0,2,3,4,5,6,8,12,14,15,16,17,18,20,24; Period 3 TID: hrs 0,2,3,4,5,6,8,10,11,12,13,14,16,18,19,20,21,22,24
Results posted on
2016-05-30
Participant Flow
The planned enrollment for this study was up to 28 subjects. The actual enrollment of the study was 25 subjects, all of whom were included in the safety and PK evaluable populations. This was a single-center study conducted at San Diego Sexual Medicine medical clinic. First patient screened 27Aug2014, FPE 05Sep2014, LPE 28Jan2015, LPLV 24Apr2015.
Period 1: Each study subject received 5 escalating single doses of TSX-002. Period 2: Each study subject dose was 90 mg BID of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level was drawn and used to determine eligibility for randomization to a further treatment group (BID vs. TID) or continuation in a BID treatment regimen.
Participant milestones
| Measure |
Period 1: Single Dose
Period 1: Each study subject will receive an escalating single dose of TSX-002 (60, 90, 120, 180, 240 mg), with a minimum 3 day wash-out between each of the 5 escalating doses. After completing the 240 mg dose, a 7 day wash-out period will occur prior to Period 2.
|
Period 2: Two Times Daily Dosing 90 mg
Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days.
|
Period 3: Two Times Daily Dosing 120 mg
Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.
Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment.
|
Period 3: Three Times Daily Dosing 90 mg
Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.
Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment.
|
Period 3: Two Times Daily Dosing 180 mg
Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.
Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment.
|
Period 3: Three Times Daily Dosing 120 mg
Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.
Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment.
|
|---|---|---|---|---|---|---|
|
Period 1: Single Dose
STARTED
|
25
|
0
|
0
|
0
|
0
|
0
|
|
Period 1: Single Dose
COMPLETED
|
21
|
0
|
0
|
0
|
0
|
0
|
|
Period 1: Single Dose
NOT COMPLETED
|
4
|
0
|
0
|
0
|
0
|
0
|
|
Period 2: Two Times Daily Dosing 90 mg
STARTED
|
0
|
21
|
0
|
0
|
0
|
0
|
|
Period 2: Two Times Daily Dosing 90 mg
COMPLETED
|
0
|
21
|
0
|
0
|
0
|
0
|
|
Period 2: Two Times Daily Dosing 90 mg
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 3
STARTED
|
0
|
0
|
4
|
1
|
8
|
8
|
|
Period 3
COMPLETED
|
0
|
0
|
4
|
1
|
8
|
7
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Period 1: Single Dose
Period 1: Each study subject will receive an escalating single dose of TSX-002 (60, 90, 120, 180, 240 mg), with a minimum 3 day wash-out between each of the 5 escalating doses. After completing the 240 mg dose, a 7 day wash-out period will occur prior to Period 2.
|
Period 2: Two Times Daily Dosing 90 mg
Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days.
|
Period 3: Two Times Daily Dosing 120 mg
Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.
Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment.
|
Period 3: Three Times Daily Dosing 90 mg
Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.
Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment.
|
Period 3: Two Times Daily Dosing 180 mg
Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.
Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment.
|
Period 3: Three Times Daily Dosing 120 mg
Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.
Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment.
|
|---|---|---|---|---|---|---|
|
Period 1: Single Dose
Withdrawal by Subject
|
4
|
0
|
0
|
0
|
0
|
0
|
|
Period 3
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Oral Testosterone for the Treatment of Hypogonadism in Males
Baseline characteristics by cohort
| Measure |
All Study Participants
n=25 Participants
Study participants start in Period 1 and proceed to Period 2 and then Period 3 Period 1: Each study subject will receive an escalating single dose of TSX-002 (60, 90, 120, 180, 240 mg), with a minimum 3 day wash-out between each of the 5 escalating doses. After completing the 240 mg dose, a 7 day wash-out period will occur prior to Period 2.
Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days.
Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
54.4 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Cavg from samples at Period 1: post dose hrs 0,1,2,3,4,5,6,8,12,16,24; Period 2: hrs 0,2,3,4,5,6,8,12,14,15,16,17,18,20,24; Period 3 BID: hrs 0,2,3,4,5,6,8,12,14,15,16,17,18,20,24; Period 3 TID: hrs 0,2,3,4,5,6,8,10,11,12,13,14,16,18,19,20,21,22,24Population: Subjects who received TSX-002 and provided PK concentrations for the protocol required 24 hour collection periods.
Percentage of subjects with response to treatment within each period. Response to treatment was considered when Testosterone Cavg was within the physiological range of Testosterone concentration, i.e. 300 - 1050 ng/dL.
Outcome measures
| Measure |
Period 1: Single Dose
n=25 Participants
Period 1: Each study subject will receive an escalating single dose of TSX-002 (60, 90, 120, 180, 240 mg), with a minimum 3 day wash-out between each of the 5 escalating doses. After completing the 240 mg dose, a 7 day wash-out period will occur prior to Period 2.
|
Period 2: Two Times Daily Dosing 90 mg
n=21 Participants
Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days.
|
Period 3: Two Times Daily Dosing 120 mg
n=4 Participants
Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.
Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment.
|
Period 3: Three Times Daily Dosing 90 mg
n=1 Participants
Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.
Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment.
|
Period 3: Two Times Daily Dosing 180 mg
n=8 Participants
Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.
Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment.
|
Period 3: Three Times Daily Dosing 120 mg
n=7 Participants
Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.
Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment.
|
|---|---|---|---|---|---|---|
|
Percentage of Responders
|
67 percentage of subjects
|
57 percentage of subjects
|
50 percentage of subjects
|
100 percentage of subjects
|
25 percentage of subjects
|
57.1 percentage of subjects
|
Adverse Events
Period 1: Single Dose
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Period 2: Two Times Daily Dosing 90 mg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Period 3: Two Times Daily Dosing 120 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Period 3: Three Times Daily Dosing 90 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Period 3: Two Times Daily Dosing 180 mg
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Period 3: Three Times Daily Dosing 120 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Period 1: Single Dose
n=25 participants at risk
Period 1: Each study subject will receive an escalating single dose of TSX-002 (60, 90, 120, 180, 240 mg), with a minimum 3 day wash-out between each of the 5 escalating doses. After completing the 240 mg dose, a 7 day wash-out period will occur prior to Period 2.
|
Period 2: Two Times Daily Dosing 90 mg
n=21 participants at risk
Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days.
|
Period 3: Two Times Daily Dosing 120 mg
n=4 participants at risk
Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.
Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment.
|
Period 3: Three Times Daily Dosing 90 mg
n=1 participants at risk
Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.
Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment.
|
Period 3: Two Times Daily Dosing 180 mg
n=8 participants at risk
Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.
Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment.
|
Period 3: Three Times Daily Dosing 120 mg
n=8 participants at risk
Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.
Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment.
|
|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/25 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
0.00%
0/21 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
0.00%
0/4 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
0.00%
0/1 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
12.5%
1/8 • Number of events 1 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
0.00%
0/8 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
Other adverse events
| Measure |
Period 1: Single Dose
n=25 participants at risk
Period 1: Each study subject will receive an escalating single dose of TSX-002 (60, 90, 120, 180, 240 mg), with a minimum 3 day wash-out between each of the 5 escalating doses. After completing the 240 mg dose, a 7 day wash-out period will occur prior to Period 2.
|
Period 2: Two Times Daily Dosing 90 mg
n=21 participants at risk
Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days.
|
Period 3: Two Times Daily Dosing 120 mg
n=4 participants at risk
Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.
Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment.
|
Period 3: Three Times Daily Dosing 90 mg
n=1 participants at risk
Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.
Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment.
|
Period 3: Two Times Daily Dosing 180 mg
n=8 participants at risk
Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.
Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment.
|
Period 3: Three Times Daily Dosing 120 mg
n=8 participants at risk
Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.
Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/25 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
9.5%
2/21 • Number of events 2 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
0.00%
0/4 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
0.00%
0/1 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
0.00%
0/8 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
0.00%
0/8 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
|
Infections and infestations
Rhinitis
|
0.00%
0/25 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
14.3%
3/21 • Number of events 3 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
0.00%
0/4 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
0.00%
0/1 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
0.00%
0/8 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
0.00%
0/8 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
|
Investigations
Prostatic specific antigen increased
|
0.00%
0/25 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
0.00%
0/21 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
0.00%
0/4 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
0.00%
0/1 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
12.5%
1/8 • Number of events 1 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
12.5%
1/8 • Number of events 1 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
|
Nervous system disorders
Headache
|
20.0%
5/25 • Number of events 7 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
19.0%
4/21 • Number of events 4 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
0.00%
0/4 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
100.0%
1/1 • Number of events 1 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
12.5%
1/8 • Number of events 1 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
12.5%
1/8 • Number of events 1 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
|
General disorders
Oedema Peripheral
|
0.00%
0/25 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
0.00%
0/21 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
25.0%
1/4 • Number of events 2 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
0.00%
0/1 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
0.00%
0/8 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
0.00%
0/8 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/25 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
0.00%
0/21 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
0.00%
0/4 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
0.00%
0/1 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
12.5%
1/8 • Number of events 1 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
0.00%
0/8 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
|
Investigations
Blood potassium increased
|
0.00%
0/25 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
0.00%
0/21 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
0.00%
0/4 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
0.00%
0/1 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
12.5%
1/8 • Number of events 1 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
0.00%
0/8 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/25 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
0.00%
0/21 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
0.00%
0/4 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
0.00%
0/1 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
12.5%
1/8 • Number of events 1 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
0.00%
0/8 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/25 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
0.00%
0/21 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
0.00%
0/4 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
0.00%
0/1 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
12.5%
1/8 • Number of events 1 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
0.00%
0/8 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/25 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
0.00%
0/21 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
0.00%
0/4 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
0.00%
0/1 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
12.5%
1/8 • Number of events 1 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
0.00%
0/8 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/25 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
0.00%
0/21 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
0.00%
0/4 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
0.00%
0/1 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
12.5%
1/8 • Number of events 1 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
0.00%
0/8 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/25 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
0.00%
0/21 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
0.00%
0/4 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
100.0%
1/1 • Number of events 1 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
0.00%
0/8 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
0.00%
0/8 • 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit. Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
|
Additional Information
Michael Oefelein, MD, Chief Medical Officer
TesoRx Pharma, LLC
Phone: 909-595-0500
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee At 60 days prior to submitting or presenting a manuscript or other materials relating to the Study to a publisher, reviewer, or other outside persons, the Site shall provide to Sponsor a copy and allow Sponsor 60 days to review and comment and provide written permission prior to publication.
- Publication restrictions are in place
Restriction type: OTHER