Trial Outcomes & Findings for Phase I/II Trial of Letrozole and Sorafenib in Post-Menopausal Hormone-Receptor + Breast Cancer (NCT NCT00634634)
NCT ID: NCT00634634
Last Updated: 2023-11-09
Results Overview
The highest dose of the drug that does not cause unacceptable side effects. The maximum tolerated dose be testing increasing doses until the highest dose with acceptable side effects is found.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
52 participants
Primary outcome timeframe
twenty eight days
Results posted on
2023-11-09
Participant Flow
13 participants in Phase I + 39 participants enrolled in Phase II = 52 participants that appear to be enrolled in this study.
Participant milestones
| Measure |
Phase l Sorafenib Dose Escalation and Letrozole 2.5mg po Daily Dose Level -1
Sorafenib: sorafenib dose will be given at a daily dose to be determined based upon the phase of study that patient is enrolled The phase II dose of sorafenib will be determined from the phase I portion of the study.
Dose Level -1: Sorafenib 400mg po every other day. Letrozole: Patients will take letrozole orally at a daily dose of 2.5 mg/day on Days 1 through 28
|
Phase l Sorafenib Dose Escalation and Letrozole 2.5mg Daily Dose Level 0:Sorafenib 400mg 1X Daily
Sorafenib: s dose will be given at a daily dose to be determined based upon the phase of study that patient is enrolled The phase II dose of sorafenib will be determined from the phase I portion of the study
Dose Level 0: Sorafenib 400mg 1X daily Letrozole: Patients will take letrozole orally at a daily dose of 2.5 mg/day on Days 1 through 28
|
Phase l Sorafenib Dose Escalation and Letrozole 2.5mg po Daily Dose Level 1: Sorafenib 400mg 2X Day
Sorafenib: sorafenib dose will be given at a daily dose to be determined based upon the phase of study that patient is enrolled The phase II dose of sorafenib will be determined from the phase I portion of the study.
Dose Level 1: Sorafenib 400mg 2X day. Letrozole: Patients will take letrozole orally at a daily dose of 2.5 mg/day on Days 1 through 28
|
Phase II Arm - Sorafenib at MTD (400mg) 2x a Day + Letrozole 2.5 mg po Daily
Sorafenib 400mg 2X day. Letrozole: Patients will take letrozole orally at a daily dose of 2.5 mg/day
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
3
|
9
|
39
|
|
Overall Study
COMPLETED
|
1
|
3
|
9
|
39
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase I/II Trial of Letrozole and Sorafenib in Post-Menopausal Hormone-Receptor + Breast Cancer
Baseline characteristics by cohort
| Measure |
Phase l Sorafenib Dose Escalation and Letrozole 2.5mg po Daily Dose Level -1
n=1 Participants
Sorafenib: sorafenib dose will be given at a daily dose to be determined based upon the phase of study that patient is enrolled The phase II dose of sorafenib will be determined from the phase I portion of the study.
Dose Level -1: Sorafenib 400mg po every other day. Letrozole: Patients will take letrozole orally at a daily dose of 2.5 mg/day on Days 1 through 28
|
Phase l Sorafenib Dose Escalation and Letrozole 2.5mg Daily Dose Level 0:Sorafenib 400mg 1X Daily
n=3 Participants
Sorafenib: s dose will be given at a daily dose to be determined based upon the phase of study that patient is enrolled The phase II dose of sorafenib will be determined from the phase I portion of the study
Dose Level 0: Sorafenib 400mg 1X daily Letrozole: Patients will take letrozole orally at a daily dose of 2.5 mg/day on Days 1 through 28
|
Phase l Sorafenib Dose Escalation and Letrozole 2.5mg po Daily Dose Level 1: Sorafenib 400mg 2X Day
n=9 Participants
Sorafenib: sorafenib dose will be given at a daily dose to be determined based upon the phase of study that patient is enrolled The phase II dose of sorafenib will be determined from the phase I portion of the study.
Dose Level 1: Sorafenib 400mg 2X day. Letrozole: Patients will take letrozole orally at a daily dose of 2.5 mg/day on Days 1 through 28
|
Phase II Arm - Sorafenib at MTD (400mg) 2x a Day + Letrozole 2.5 mg po Daily
n=39 Participants
Sorafenib 400mg 2X day. Letrozole: Patients will take letrozole orally at a daily dose of 2.5 mg/day
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
36 Participants
n=483 Participants
|
40 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
12 Participants
n=36 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
39 Participants
n=483 Participants
|
52 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
10 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
25 Participants
n=483 Participants
|
38 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=93 Participants
|
3 participants
n=4 Participants
|
9 participants
n=27 Participants
|
39 participants
n=483 Participants
|
52 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: twenty eight daysPopulation: The primary outcome is the maximum tolerated dose, which is the highest dose of the drug that does not cause unacceptable side effects. The maximum tolerated dose was only analyzed. Then phase 2 added 39 participates.
The highest dose of the drug that does not cause unacceptable side effects. The maximum tolerated dose be testing increasing doses until the highest dose with acceptable side effects is found.
Outcome measures
| Measure |
Sorafenib in Combination With Fixed Dose of of 2.5mg of Letrozole Maximum Tolerated Dose (MTD)
n=13 Participants
The highest dose of the drug that does not cause unacceptable side effects. The maximum tolerated dose be testing increasing doses until the highest dose with acceptable side effects is found.
|
Phase l Sorafenib Dose Escalation and Letrozole 2.5mg Daily Dose Level 0:Sorafenib 400mg 1X Daily
Sorafenib: s dose will be given at a daily dose to be determined based upon the phase of study that patient is enrolled The phase II dose of sorafenib will be determined from the phase I portion of the study Dose Level 0: Sorafenib 400mg 1X daily Letrozole: Patients will take letrozole orally at a daily dose of 2.5 mg/day on Days 1 through 28
|
Phase l Sorafenib Dose Escalation and Letrozole 2.5mg po Daily Dose Level 1: Sorafenib 400mg 2X Day
Sorafenib: sorafenib dose will be given at a daily dose to be determined based upon the phase of study that patient is enrolled The phase II dose of sorafenib will be determined from the phase I portion of the study.
Dose Level 1: Sorafenib 400mg 2X day. Letrozole: Patients will take letrozole orally at a daily dose of 2.5 mg/day on Days 1 through 28
|
Phase II Arm - Sorafenib at MTD (400mg) 2x a Day + Letrozole 2.5 mg po Daily
Sorafenib 400mg 2X day. Letrozole: Patients will take letrozole orally at a daily dose of 2.5 mg/day
|
|---|---|---|---|---|
|
Sorafenib in Combination With Fixed Dose of of 2.5mg of Letrozole Maximum Tolerated Dose (MTD)
|
400 milligrams twice daily
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 monthsChanges in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the malignant lymph nodes are used for tumor measurements. Included will be: complete response, partial response or stable disease of letrozole and sorafenib in the treatment of postmenopausal participants with hormone receptor- positive locally advanced or metastatic breast cancer. Clinical Benefit Rate (CBR) = Progressive Free (PF) + Stable Disease (SD)
Outcome measures
| Measure |
Sorafenib in Combination With Fixed Dose of of 2.5mg of Letrozole Maximum Tolerated Dose (MTD)
n=1 Participants
The highest dose of the drug that does not cause unacceptable side effects. The maximum tolerated dose be testing increasing doses until the highest dose with acceptable side effects is found.
|
Phase l Sorafenib Dose Escalation and Letrozole 2.5mg Daily Dose Level 0:Sorafenib 400mg 1X Daily
n=3 Participants
Sorafenib: s dose will be given at a daily dose to be determined based upon the phase of study that patient is enrolled The phase II dose of sorafenib will be determined from the phase I portion of the study Dose Level 0: Sorafenib 400mg 1X daily Letrozole: Patients will take letrozole orally at a daily dose of 2.5 mg/day on Days 1 through 28
|
Phase l Sorafenib Dose Escalation and Letrozole 2.5mg po Daily Dose Level 1: Sorafenib 400mg 2X Day
n=9 Participants
Sorafenib: sorafenib dose will be given at a daily dose to be determined based upon the phase of study that patient is enrolled The phase II dose of sorafenib will be determined from the phase I portion of the study.
Dose Level 1: Sorafenib 400mg 2X day. Letrozole: Patients will take letrozole orally at a daily dose of 2.5 mg/day on Days 1 through 28
|
Phase II Arm - Sorafenib at MTD (400mg) 2x a Day + Letrozole 2.5 mg po Daily
n=39 Participants
Sorafenib 400mg 2X day. Letrozole: Patients will take letrozole orally at a daily dose of 2.5 mg/day
|
|---|---|---|---|---|
|
Clinical Benefit Rate Using the Response Evaluation Criteria in Solid Tumors (RECIST) Guidelines (Version 1.1) to Letrozole and Sorafenib
|
0 Participants
|
3 Participants
|
4 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: Approximately 4.6 yearsPFS based on the Kaplan-Meier method is defined as the time between randomization and documented disease progression (PD) per RECIST 1,0 criteria or death, or is censored at time of last disease assessment. Per RECIST 1.0f or target lesions, PD is at least a 20% increase in sum LD of target lesions, taken as reference the smallest sum LD recorded at treatment started. Based on the time between the first day of treatment and and the date of disease progression.
Outcome measures
| Measure |
Sorafenib in Combination With Fixed Dose of of 2.5mg of Letrozole Maximum Tolerated Dose (MTD)
n=1 Participants
The highest dose of the drug that does not cause unacceptable side effects. The maximum tolerated dose be testing increasing doses until the highest dose with acceptable side effects is found.
|
Phase l Sorafenib Dose Escalation and Letrozole 2.5mg Daily Dose Level 0:Sorafenib 400mg 1X Daily
n=3 Participants
Sorafenib: s dose will be given at a daily dose to be determined based upon the phase of study that patient is enrolled The phase II dose of sorafenib will be determined from the phase I portion of the study Dose Level 0: Sorafenib 400mg 1X daily Letrozole: Patients will take letrozole orally at a daily dose of 2.5 mg/day on Days 1 through 28
|
Phase l Sorafenib Dose Escalation and Letrozole 2.5mg po Daily Dose Level 1: Sorafenib 400mg 2X Day
n=9 Participants
Sorafenib: sorafenib dose will be given at a daily dose to be determined based upon the phase of study that patient is enrolled The phase II dose of sorafenib will be determined from the phase I portion of the study.
Dose Level 1: Sorafenib 400mg 2X day. Letrozole: Patients will take letrozole orally at a daily dose of 2.5 mg/day on Days 1 through 28
|
Phase II Arm - Sorafenib at MTD (400mg) 2x a Day + Letrozole 2.5 mg po Daily
n=39 Participants
Sorafenib 400mg 2X day. Letrozole: Patients will take letrozole orally at a daily dose of 2.5 mg/day
|
|---|---|---|---|---|
|
Median Progressive-Free Survival (PFS)
|
0 months
Interval 0.0 to 0.0
|
10 months
Interval 5.0 to 15.0
|
34.5 months
Interval 5.0 to 66.0
|
11 months
Interval 1.0 to 52.0
|
SECONDARY outcome
Timeframe: Approximately 4.6 yearsFrom the start of treatment to the end of the study (three years) that participants are still alive. Measured by the mean number.
Outcome measures
| Measure |
Sorafenib in Combination With Fixed Dose of of 2.5mg of Letrozole Maximum Tolerated Dose (MTD)
n=1 Participants
The highest dose of the drug that does not cause unacceptable side effects. The maximum tolerated dose be testing increasing doses until the highest dose with acceptable side effects is found.
|
Phase l Sorafenib Dose Escalation and Letrozole 2.5mg Daily Dose Level 0:Sorafenib 400mg 1X Daily
n=3 Participants
Sorafenib: s dose will be given at a daily dose to be determined based upon the phase of study that patient is enrolled The phase II dose of sorafenib will be determined from the phase I portion of the study Dose Level 0: Sorafenib 400mg 1X daily Letrozole: Patients will take letrozole orally at a daily dose of 2.5 mg/day on Days 1 through 28
|
Phase l Sorafenib Dose Escalation and Letrozole 2.5mg po Daily Dose Level 1: Sorafenib 400mg 2X Day
n=9 Participants
Sorafenib: sorafenib dose will be given at a daily dose to be determined based upon the phase of study that patient is enrolled The phase II dose of sorafenib will be determined from the phase I portion of the study.
Dose Level 1: Sorafenib 400mg 2X day. Letrozole: Patients will take letrozole orally at a daily dose of 2.5 mg/day on Days 1 through 28
|
Phase II Arm - Sorafenib at MTD (400mg) 2x a Day + Letrozole 2.5 mg po Daily
n=39 Participants
Sorafenib 400mg 2X day. Letrozole: Patients will take letrozole orally at a daily dose of 2.5 mg/day
|
|---|---|---|---|---|
|
Overall Survival (OS) Assessed as Mean Months
|
44 months
Interval 44.0 to 44.0
|
21 months
Interval 17.0 to 25.0
|
49.6 months
Interval 38.0 to 56.0
|
24.8 months
Interval 1.0 to 49.0
|
Adverse Events
Phase l Sorafenib Dose Escalation and Letrozole 2.5mg po Daily Dose Level -1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Phase l Sorafenib Dose Escalation and Letrozole 2.5mg Daily Dose Level 0:Sorafenib 400mg 1X Daily
Serious events: 1 serious events
Other events: 3 other events
Deaths: 2 deaths
Phase l Sorafenib Dose Escalation and Letrozole 2.5mg po Daily Dose Level 1: Sorafenib 400mg 2X Day
Serious events: 0 serious events
Other events: 9 other events
Deaths: 7 deaths
Phase II Arm - Sorafenib at MTD (400mg) 2x a Day + Letrozole 2.5 mg po Daily
Serious events: 3 serious events
Other events: 39 other events
Deaths: 24 deaths
Serious adverse events
| Measure |
Phase l Sorafenib Dose Escalation and Letrozole 2.5mg po Daily Dose Level -1
n=1 participants at risk
Sorafenib: sorafenib dose will be given at a daily dose to be determined based upon the phase of study that patient is enrolled The phase II dose of sorafenib will be determined from the phase I portion of the study.
Dose Level -1: Sorafenib 400mg po every other day. Letrozole: Patients will take letrozole orally at a daily dose of 2.5 mg/day on Days 1 through 28
|
Phase l Sorafenib Dose Escalation and Letrozole 2.5mg Daily Dose Level 0:Sorafenib 400mg 1X Daily
n=3 participants at risk
Sorafenib: s dose will be given at a daily dose to be determined based upon the phase of study that patient is enrolled The phase II dose of sorafenib will be determined from the phase I portion of the study
Dose Level 0: Sorafenib 400mg 1X daily Letrozole: Patients will take letrozole orally at a daily dose of 2.5 mg/day on Days 1 through 28
|
Phase l Sorafenib Dose Escalation and Letrozole 2.5mg po Daily Dose Level 1: Sorafenib 400mg 2X Day
n=9 participants at risk
Sorafenib: sorafenib dose will be given at a daily dose to be determined based upon the phase of study that patient is enrolled The phase II dose of sorafenib will be determined from the phase I portion of the study.
Dose Level 1: Sorafenib 400mg 2X day. Letrozole: Patients will take letrozole orally at a daily dose of 2.5 mg/day on Days 1 through 28
|
Phase II Arm - Sorafenib at MTD (400mg) 2x a Day + Letrozole 2.5 mg po Daily
n=39 participants at risk
Sorafenib 400mg 2X day. Letrozole: Patients will take letrozole orally at a daily dose of 2.5 mg/day
|
|---|---|---|---|---|
|
Cardiac disorders
Hypertension
|
0.00%
0/1 • Approximately 4.6 years
|
33.3%
1/3 • Number of events 2 • Approximately 4.6 years
|
0.00%
0/9 • Approximately 4.6 years
|
2.6%
1/39 • Number of events 1 • Approximately 4.6 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • Approximately 4.6 years
|
33.3%
1/3 • Number of events 1 • Approximately 4.6 years
|
0.00%
0/9 • Approximately 4.6 years
|
0.00%
0/39 • Approximately 4.6 years
|
|
Infections and infestations
Infection
|
0.00%
0/1 • Approximately 4.6 years
|
33.3%
1/3 • Number of events 2 • Approximately 4.6 years
|
0.00%
0/9 • Approximately 4.6 years
|
0.00%
0/39 • Approximately 4.6 years
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • Approximately 4.6 years
|
33.3%
1/3 • Number of events 2 • Approximately 4.6 years
|
0.00%
0/9 • Approximately 4.6 years
|
2.6%
1/39 • Number of events 1 • Approximately 4.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/1 • Approximately 4.6 years
|
0.00%
0/3 • Approximately 4.6 years
|
0.00%
0/9 • Approximately 4.6 years
|
2.6%
1/39 • Number of events 1 • Approximately 4.6 years
|
|
Hepatobiliary disorders
Hepatobiliary
|
0.00%
0/1 • Approximately 4.6 years
|
0.00%
0/3 • Approximately 4.6 years
|
0.00%
0/9 • Approximately 4.6 years
|
2.6%
1/39 • Number of events 1 • Approximately 4.6 years
|
|
General disorders
Pain - Headaches
|
0.00%
0/1 • Approximately 4.6 years
|
33.3%
1/3 • Number of events 1 • Approximately 4.6 years
|
0.00%
0/9 • Approximately 4.6 years
|
0.00%
0/39 • Approximately 4.6 years
|
Other adverse events
| Measure |
Phase l Sorafenib Dose Escalation and Letrozole 2.5mg po Daily Dose Level -1
n=1 participants at risk
Sorafenib: sorafenib dose will be given at a daily dose to be determined based upon the phase of study that patient is enrolled The phase II dose of sorafenib will be determined from the phase I portion of the study.
Dose Level -1: Sorafenib 400mg po every other day. Letrozole: Patients will take letrozole orally at a daily dose of 2.5 mg/day on Days 1 through 28
|
Phase l Sorafenib Dose Escalation and Letrozole 2.5mg Daily Dose Level 0:Sorafenib 400mg 1X Daily
n=3 participants at risk
Sorafenib: s dose will be given at a daily dose to be determined based upon the phase of study that patient is enrolled The phase II dose of sorafenib will be determined from the phase I portion of the study
Dose Level 0: Sorafenib 400mg 1X daily Letrozole: Patients will take letrozole orally at a daily dose of 2.5 mg/day on Days 1 through 28
|
Phase l Sorafenib Dose Escalation and Letrozole 2.5mg po Daily Dose Level 1: Sorafenib 400mg 2X Day
n=9 participants at risk
Sorafenib: sorafenib dose will be given at a daily dose to be determined based upon the phase of study that patient is enrolled The phase II dose of sorafenib will be determined from the phase I portion of the study.
Dose Level 1: Sorafenib 400mg 2X day. Letrozole: Patients will take letrozole orally at a daily dose of 2.5 mg/day on Days 1 through 28
|
Phase II Arm - Sorafenib at MTD (400mg) 2x a Day + Letrozole 2.5 mg po Daily
n=39 participants at risk
Sorafenib 400mg 2X day. Letrozole: Patients will take letrozole orally at a daily dose of 2.5 mg/day
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin
|
100.0%
1/1 • Number of events 3 • Approximately 4.6 years
|
0.00%
0/3 • Approximately 4.6 years
|
77.8%
7/9 • Number of events 11 • Approximately 4.6 years
|
71.8%
28/39 • Number of events 67 • Approximately 4.6 years
|
|
Infections and infestations
Infection
|
0.00%
0/1 • Approximately 4.6 years
|
33.3%
1/3 • Number of events 1 • Approximately 4.6 years
|
44.4%
4/9 • Number of events 8 • Approximately 4.6 years
|
28.2%
11/39 • Number of events 14 • Approximately 4.6 years
|
|
Vascular disorders
Vascular
|
0.00%
0/1 • Approximately 4.6 years
|
0.00%
0/3 • Approximately 4.6 years
|
11.1%
1/9 • Number of events 1 • Approximately 4.6 years
|
0.00%
0/39 • Approximately 4.6 years
|
|
Cardiac disorders
Cardiac
|
0.00%
0/1 • Approximately 4.6 years
|
33.3%
1/3 • Number of events 1 • Approximately 4.6 years
|
22.2%
2/9 • Number of events 2 • Approximately 4.6 years
|
38.5%
15/39 • Number of events 23 • Approximately 4.6 years
|
|
General disorders
General
|
0.00%
0/1 • Approximately 4.6 years
|
0.00%
0/3 • Approximately 4.6 years
|
33.3%
3/9 • Number of events 7 • Approximately 4.6 years
|
48.7%
19/39 • Number of events 64 • Approximately 4.6 years
|
|
Blood and lymphatic system disorders
Blood
|
0.00%
0/1 • Approximately 4.6 years
|
33.3%
1/3 • Number of events 1 • Approximately 4.6 years
|
11.1%
1/9 • Number of events 1 • Approximately 4.6 years
|
10.3%
4/39 • Number of events 12 • Approximately 4.6 years
|
|
Reproductive system and breast disorders
Reproductive
|
0.00%
0/1 • Approximately 4.6 years
|
0.00%
0/3 • Approximately 4.6 years
|
11.1%
1/9 • Number of events 1 • Approximately 4.6 years
|
0.00%
0/39 • Approximately 4.6 years
|
|
Gastrointestinal disorders
Gastrointestinal
|
0.00%
0/1 • Approximately 4.6 years
|
33.3%
1/3 • Number of events 1 • Approximately 4.6 years
|
33.3%
3/9 • Number of events 10 • Approximately 4.6 years
|
48.7%
19/39 • Number of events 39 • Approximately 4.6 years
|
|
General disorders
Pain
|
0.00%
0/1 • Approximately 4.6 years
|
0.00%
0/3 • Approximately 4.6 years
|
44.4%
4/9 • Number of events 8 • Approximately 4.6 years
|
59.0%
23/39 • Number of events 72 • Approximately 4.6 years
|
|
Cardiac disorders
Hypertension
|
0.00%
0/1 • Approximately 4.6 years
|
0.00%
0/3 • Approximately 4.6 years
|
44.4%
4/9 • Number of events 4 • Approximately 4.6 years
|
48.7%
19/39 • Number of events 27 • Approximately 4.6 years
|
|
General disorders
constitutional Symptoms
|
0.00%
0/1 • Approximately 4.6 years
|
0.00%
0/3 • Approximately 4.6 years
|
44.4%
4/9 • Number of events 7 • Approximately 4.6 years
|
38.5%
15/39 • Number of events 26 • Approximately 4.6 years
|
|
General disorders
Metabolic
|
0.00%
0/1 • Approximately 4.6 years
|
0.00%
0/3 • Approximately 4.6 years
|
33.3%
3/9 • Number of events 3 • Approximately 4.6 years
|
30.8%
12/39 • Number of events 21 • Approximately 4.6 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place