Trial Outcomes & Findings for Testosterone in Treating Postmenopausal Patients With Arthralgia Caused by Adjuvant Aromatase Inhibitor Treatment (NCT NCT01573442)
NCT ID: NCT01573442
Last Updated: 2025-01-28
Results Overview
The average change in Brief Pain Inventory (BPI) Average Pain scores between baseline and month 3 using Wilcoxon test are reported for each arm below. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
227 participants
Primary outcome timeframe
From baseline to 3 months
Results posted on
2025-01-28
Participant Flow
Participant milestones
| Measure |
Arm II (Placebo)
Patients receive placebo (0.264mL) topical application daily for six months.
|
Arm I (Testosterone)
Patients receive testosterone (0.264mL) topical application daily for six months.
|
|---|---|---|
|
Overall Study
STARTED
|
113
|
114
|
|
Overall Study
COMPLETED
|
104
|
104
|
|
Overall Study
NOT COMPLETED
|
9
|
10
|
Reasons for withdrawal
| Measure |
Arm II (Placebo)
Patients receive placebo (0.264mL) topical application daily for six months.
|
Arm I (Testosterone)
Patients receive testosterone (0.264mL) topical application daily for six months.
|
|---|---|---|
|
Overall Study
Cancels
|
9
|
10
|
Baseline Characteristics
Testosterone in Treating Postmenopausal Patients With Arthralgia Caused by Adjuvant Aromatase Inhibitor Treatment
Baseline characteristics by cohort
| Measure |
Arm II (Placebo)
n=104 Participants
Patients receive placebo (0.264mL) topical application daily for six months.
|
Arm I (Testosterone)
n=104 Participants
Patients receive testosterone (0.264mL) topical application daily for six months.
|
Total
n=208 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.1 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
59.9 years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
60.0 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
104 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
208 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
94 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
194 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
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
ECOG Performance Status
0
|
81 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
162 Participants
n=5 Participants
|
|
ECOG Performance Status
1
|
23 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
ECOG Performance Status
2
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline to 3 monthsPopulation: Patients who completed item #3 (average) of the BPI at baseline and month 3 time points are included in this analysis.
The average change in Brief Pain Inventory (BPI) Average Pain scores between baseline and month 3 using Wilcoxon test are reported for each arm below. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.
Outcome measures
| Measure |
Arm II (Placebo)
n=76 Participants
Patients receive placebo (0.264mL) topical application daily for six months.
|
Arm I (Testosterone)
n=82 Participants
Patients receive testosterone (0.264mL) topical application daily for six months.
|
|---|---|---|
|
Change in Item #3 (Average) of the Brief Pain Inventory (BPI) Average Pain From Baseline to Month 3
|
-1.9 score on a scale
Standard Deviation 2.5
|
-2.0 score on a scale
Standard Deviation 2.5
|
PRIMARY outcome
Timeframe: Up to 3 months"2. Was there an improvement in BPI Average Pain from baseline to month 3?"
Outcome measures
| Measure |
Arm II (Placebo)
n=104 Participants
Patients receive placebo (0.264mL) topical application daily for six months.
|
Arm I (Testosterone)
n=104 Participants
Patients receive testosterone (0.264mL) topical application daily for six months.
|
|---|---|---|
|
Improvement in BPI Average Pain From Baseline to Month 3
No
|
55 Participants
|
45 Participants
|
|
Improvement in BPI Average Pain From Baseline to Month 3
Yes
|
49 Participants
|
59 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 monthsPopulation: Patients who completed item #3 (average) of the BPI at baseline and month 6 time points are included in this analysis.
Change in BPI Average Change from Baseline Pain Score to Month Six Average Pain Score. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.
Outcome measures
| Measure |
Arm II (Placebo)
n=68 Participants
Patients receive placebo (0.264mL) topical application daily for six months.
|
Arm I (Testosterone)
n=63 Participants
Patients receive testosterone (0.264mL) topical application daily for six months.
|
|---|---|---|
|
Change in BPI Average Change From Baseline Pain Score to Month Six Average Pain Score
|
-2.2 score on a scale
Standard Deviation 2.7
|
-1.9 score on a scale
Standard Deviation 2.2
|
PRIMARY outcome
Timeframe: Baseline and months 1-6Population: Number analyzed below are based on patients who completed the BPI Average Pain item at baseline and specified month.
Change in BPI Average Pain from baseline to month 1-6. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.
Outcome measures
| Measure |
Arm II (Placebo)
n=104 Participants
Patients receive placebo (0.264mL) topical application daily for six months.
|
Arm I (Testosterone)
n=104 Participants
Patients receive testosterone (0.264mL) topical application daily for six months.
|
|---|---|---|
|
Change in BPI Average Pain From Baseline to Month 1-6
From baseline to month 1
|
-1.2 score on a scale
Standard Deviation 2.2
|
-1.7 score on a scale
Standard Deviation 2.1
|
|
Change in BPI Average Pain From Baseline to Month 1-6
From baseline to month 2
|
-1.9 score on a scale
Standard Deviation 2.3
|
-1.9 score on a scale
Standard Deviation 2.2
|
|
Change in BPI Average Pain From Baseline to Month 1-6
From baseline to month 3
|
-1.9 score on a scale
Standard Deviation 2.5
|
-2.0 score on a scale
Standard Deviation 2.5
|
|
Change in BPI Average Pain From Baseline to Month 1-6
From baseline to month 4
|
-2.1 score on a scale
Standard Deviation 2.5
|
-2.4 score on a scale
Standard Deviation 2.5
|
|
Change in BPI Average Pain From Baseline to Month 1-6
From baseline to month 5
|
-2.1 score on a scale
Standard Deviation 2.7
|
-2.0 score on a scale
Standard Deviation 2.6
|
|
Change in BPI Average Pain From Baseline to Month 1-6
From baseline to month 6
|
-2.2 score on a scale
Standard Deviation 2.8
|
-1.9 score on a scale
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: Up to 6 monthsPopulation: Only patients who received at least one cycle of treatment and had adverse events assessed were included in this analysis.
The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns within patient groups. In addition, we will review all adverse event data that is graded as 3, 4, or 5 and classified as either "unrelated" or "unlikely to be related" to study treatment in the event of an actual relationship developing. The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment are reported below.
Outcome measures
| Measure |
Arm II (Placebo)
n=101 Participants
Patients receive placebo (0.264mL) topical application daily for six months.
|
Arm I (Testosterone)
n=100 Participants
Patients receive testosterone (0.264mL) topical application daily for six months.
|
|---|---|---|
|
Number of Participants With Grade 3 Or Higher Adverse Events Considered At Least Possibly Related to Treatment
grade 3
|
4 Participants
|
8 Participants
|
|
Number of Participants With Grade 3 Or Higher Adverse Events Considered At Least Possibly Related to Treatment
grade 4
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 6 monthsPopulation: Only patients who received at least one cycle of treatment and had adverse events assessed were included in this analysis.
The number of patients who reported alopecia using CTCAE 4.0 is reported below for each arm.
Outcome measures
| Measure |
Arm II (Placebo)
n=101 Participants
Patients receive placebo (0.264mL) topical application daily for six months.
|
Arm I (Testosterone)
n=100 Participants
Patients receive testosterone (0.264mL) topical application daily for six months.
|
|---|---|---|
|
Number of Patients Who Reported Alopecia Using CTCAE 4.0
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 6 monthsPopulation: Only patients who received at least one cycle of treatment and had adverse events assessed were included in this analysis.
The number of patients who reported acne using CTCAE 4.0 is reported below for each arm.
Outcome measures
| Measure |
Arm II (Placebo)
n=101 Participants
Patients receive placebo (0.264mL) topical application daily for six months.
|
Arm I (Testosterone)
n=100 Participants
Patients receive testosterone (0.264mL) topical application daily for six months.
|
|---|---|---|
|
Number of Patients Who Reported Acne Using CTCAE 4.0
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 6 monthsPopulation: Only patients who received at least one cycle of treatment and had adverse events assessed were included in this analysis.
The number of patients who reported hirsutism using CTCAE 4.0 is reported below for each arm by grade.
Outcome measures
| Measure |
Arm II (Placebo)
n=101 Participants
Patients receive placebo (0.264mL) topical application daily for six months.
|
Arm I (Testosterone)
n=100 Participants
Patients receive testosterone (0.264mL) topical application daily for six months.
|
|---|---|---|
|
Number of Patients Who Reported Hirsutism Using CTCAE 4.0
0-None
|
94 Participants
|
87 Participants
|
|
Number of Patients Who Reported Hirsutism Using CTCAE 4.0
1-Mild
|
7 Participants
|
10 Participants
|
|
Number of Patients Who Reported Hirsutism Using CTCAE 4.0
2-Moderate
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: baseline and week 8Population: Patients who completed the questionnaire at baseline and week 8 are included in this analysis.
Change in hot flash frequency from baseline to week 8. Hot flash frequency is a count of the number of hot flashes per day and is a number from 0 to infinity. Higher values are worse.
Outcome measures
| Measure |
Arm II (Placebo)
n=77 Participants
Patients receive placebo (0.264mL) topical application daily for six months.
|
Arm I (Testosterone)
n=72 Participants
Patients receive testosterone (0.264mL) topical application daily for six months.
|
|---|---|---|
|
Change in Hot Flash Frequency From Baseline to Week 8
|
-10.9 hot flashes/day
Standard Deviation 20.6
|
-11.4 hot flashes/day
Standard Deviation 19.3
|
SECONDARY outcome
Timeframe: baseline and month 3Population: Patients who completed MENQOL libido question 'how bothered are you by decreased sex drive' at baseline and month 3 are included in this analysis.
Change in how bothered are you by decreased sex drive from baseline to month 3. This is assessed using one question off of the MENQOL (Menopause-Specific Quality of Life) questionnaire. The question asks "How bothered are you by a decrease in your sexual drive". This is collected on a scale ranging from 0=Not at all bothered to 6=Extremely bothered, with higher values being worse.
Outcome measures
| Measure |
Arm II (Placebo)
n=104 Participants
Patients receive placebo (0.264mL) topical application daily for six months.
|
Arm I (Testosterone)
n=103 Participants
Patients receive testosterone (0.264mL) topical application daily for six months.
|
|---|---|---|
|
The Change of Libido From Baseline to Month 3 as Measured by the MENQOL
|
-0.5 score on a scale
Standard Deviation 2.1
|
-1.3 score on a scale
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: baseline and month 3The change of menopause specific quality of life from baseline to month 3 as measured by MENQOL "how bothered are you by Hot Flashes". This is one question from the MENQOL (Menopause-Specific Quality of Life) questionnaire. The question asks "How bothered are you by hot flashes or flushes". This is collected on a scale ranging from 0=Not at all bothered t 6=Extremely bothered, with higher values being worse.
Outcome measures
| Measure |
Arm II (Placebo)
n=104 Participants
Patients receive placebo (0.264mL) topical application daily for six months.
|
Arm I (Testosterone)
n=104 Participants
Patients receive testosterone (0.264mL) topical application daily for six months.
|
|---|---|---|
|
The Change of Menopause Specific Quality of Life From Baseline to Month 3 as Measured by MENQOL "How Bothered Are You by Hot Flashes"
|
-1.4 score on a scale
Standard Deviation 2.3
|
-1.4 score on a scale
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: baseline and month 3Population: Patients who complete the BPI Worst item at baseline and month 3 are included in this analysis.
Change in BPI Worst Pain from baseline to month 3. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.
Outcome measures
| Measure |
Arm II (Placebo)
n=76 Participants
Patients receive placebo (0.264mL) topical application daily for six months.
|
Arm I (Testosterone)
n=82 Participants
Patients receive testosterone (0.264mL) topical application daily for six months.
|
|---|---|---|
|
Change in BPI Worst Pain From Baseline to Month 3
|
-2.5 score on a scale
Standard Deviation 2.7
|
-2.4 score on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: baseline and month 3Population: Patients who completed the BPI Least pain item at baseline and month 3 are included in this analysis.
Change in BPI Least Pain from baseline to month 3. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.
Outcome measures
| Measure |
Arm II (Placebo)
n=76 Participants
Patients receive placebo (0.264mL) topical application daily for six months.
|
Arm I (Testosterone)
n=82 Participants
Patients receive testosterone (0.264mL) topical application daily for six months.
|
|---|---|---|
|
Change in BPI Least Pain From Baseline to Month 3
|
-1.0 score on a scale
Standard Deviation 2.8
|
-1.3 score on a scale
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: baseline and month 3Population: Patients who completed the BPI pain right now item at baseline and month 3 are included in this analysis.
Change in BPI Pain right now from baseline to month 3. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.
Outcome measures
| Measure |
Arm II (Placebo)
n=76 Participants
Patients receive placebo (0.264mL) topical application daily for six months.
|
Arm I (Testosterone)
n=82 Participants
Patients receive testosterone (0.264mL) topical application daily for six months.
|
|---|---|---|
|
Change in BPI Pain Right Now From Baseline to Month 3
|
-1.6 score on a scale
Standard Deviation 3.0
|
-2.1 score on a scale
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: baseline and month 3Population: Patients who completed the BPI item #5 on joint stiffness at baseline and month 3 are included in this analysis.
Change in average joint stiffness from baseline to month 3. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.
Outcome measures
| Measure |
Arm II (Placebo)
n=76 Participants
Patients receive placebo (0.264mL) topical application daily for six months.
|
Arm I (Testosterone)
n=82 Participants
Patients receive testosterone (0.264mL) topical application daily for six months.
|
|---|---|---|
|
Change in Average Joint Stiffness From Baseline to Month 3 as Measured by BPI Item #5 (Joint Stiffness)
|
-2.0 score on a scale
Standard Deviation 2.7
|
-2.2 score on a scale
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: baseline and month 3Population: Patients who completed the BPI item #6 at baseline and month 3 are included in this analysis.
The intrapatient change in activity level (interference of activity) for each month from baseline as measured by item#6 (interference) of the BPI-AIA. Change in general activity from baseline to month 3. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.
Outcome measures
| Measure |
Arm II (Placebo)
n=78 Participants
Patients receive placebo (0.264mL) topical application daily for six months.
|
Arm I (Testosterone)
n=80 Participants
Patients receive testosterone (0.264mL) topical application daily for six months.
|
|---|---|---|
|
The Intrapatient Change in Activity Level (Interference of Activity) for Each Month From Baseline as Measured by Item#6 (Interference) of the BPI-AIA.
|
-2.1 score on a scale
Standard Deviation 3.0
|
-2.1 score on a scale
Standard Deviation 3.1
|
Adverse Events
Arm II (Placebo)
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
Arm I (Testosterone)
Serious events: 5 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm II (Placebo)
n=101 participants at risk
Patients receive placebo (0.264mL) topical application daily for six months.
|
Arm I (Testosterone)
n=100 participants at risk
Patients receive testosterone (0.264mL) topical application daily for six months.
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/101 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
1.0%
1/100 • Number of events 1 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
0.00%
0/101 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
1.0%
1/100 • Number of events 1 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/101 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
1.0%
1/100 • Number of events 1 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
0.00%
0/101 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
1.0%
1/100 • Number of events 1 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/101 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
1.0%
1/100 • Number of events 1 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Investigations
Platelet count decreased
|
0.00%
0/101 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
1.0%
1/100 • Number of events 1 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/101 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
1.0%
1/100 • Number of events 1 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Vascular disorders
Hypertension
|
0.00%
0/101 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
1.0%
1/100 • Number of events 1 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Vascular disorders
Thromboembolic event
|
0.99%
1/101 • Number of events 1 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/100 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
Other adverse events
| Measure |
Arm II (Placebo)
n=101 participants at risk
Patients receive placebo (0.264mL) topical application daily for six months.
|
Arm I (Testosterone)
n=100 participants at risk
Patients receive testosterone (0.264mL) topical application daily for six months.
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.99%
1/101 • Number of events 1 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/100 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Cardiac disorders
Palpitations
|
0.99%
1/101 • Number of events 1 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/100 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/101 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
1.0%
1/100 • Number of events 1 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/101 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
1.0%
1/100 • Number of events 1 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
0.99%
1/101 • Number of events 1 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/100 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
General disorders
Edema face
|
0.99%
1/101 • Number of events 1 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
1.0%
1/100 • Number of events 1 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
General disorders
Localized edema
|
0.99%
1/101 • Number of events 1 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/100 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Infections and infestations
Rash pustular
|
0.99%
1/101 • Number of events 1 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/100 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/101 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
1.0%
1/100 • Number of events 1 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Infections and infestations
Skin infection
|
0.00%
0/101 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
1.0%
1/100 • Number of events 1 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Infections and infestations
Wound infection
|
0.00%
0/101 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
2.0%
2/100 • Number of events 2 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/101 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
1.0%
1/100 • Number of events 1 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.9%
9/101 • Number of events 12 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
4.0%
4/100 • Number of events 4 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/101 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
1.0%
1/100 • Number of events 1 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.99%
1/101 • Number of events 1 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
1.0%
1/100 • Number of events 1 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.0%
2/101 • Number of events 3 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/100 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/101 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
1.0%
1/100 • Number of events 1 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Nervous system disorders
Hypersomnia
|
0.99%
1/101 • Number of events 1 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/100 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/101 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
1.0%
1/100 • Number of events 1 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Nervous system disorders
Syncope
|
0.00%
0/101 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
1.0%
1/100 • Number of events 2 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Psychiatric disorders
Agitation
|
0.99%
1/101 • Number of events 1 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/100 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/101 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
1.0%
1/100 • Number of events 1 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Reproductive system and breast disorders
Vaginal dryness
|
0.00%
0/101 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
1.0%
1/100 • Number of events 2 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Skin and subcutaneous tissue disorders
Hirsutism
|
6.9%
7/101 • Number of events 11 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
13.0%
13/100 • Number of events 19 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/101 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
1.0%
1/100 • Number of events 1 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
4.0%
4/101 • Number of events 4 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
9.0%
9/100 • Number of events 12 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Vascular disorders
Hypertension
|
2.0%
2/101 • Number of events 2 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
1.0%
1/100 • Number of events 1 • Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place