Trial Outcomes & Findings for Dactinomycin or Methotrexate in Treating Patients With Low-Risk Gestational Trophoblastic Neoplasia (NCT NCT01535053)
NCT ID: NCT01535053
Last Updated: 2022-08-12
Results Overview
Complete Response is defined as 3 consecutive bi-weekly values of hCG\<5 over a minimum of 4 weeks of normal hCG values with no values greater than 5 mIU/ml
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
57 participants
Primary outcome timeframe
hCG testing is performed prior to each cycle to treatment until treatment is completed, up to 10 months. For patients who have responded to treatment hCG must be obtained every 4 weeks for 1 year after completing treatment.
Results posted on
2022-08-12
Participant Flow
The study was activated on 6/18/2012and closed to accrual prematurely on 9/20/2016 by the sponsor due to slow accrual.
Sites declared in advance which of 2 methotrexate regimens they would follow for patients who received a random treatment allocation to the methotrexate arm. Randomization is stratified by country (US, Canada, Japan, Korea, Australia, United Kingdom, etc.) and Multi-day methotrexate regimen (8- or 5-day) used by the participating site.
Participant milestones
| Measure |
Regimen I (Dactinomycin)
IV pulse actinomycin-D (1.25mg/m2 ) every 14 days. (2mg max dose)
|
Regimen II (Methotrexate)
institutional preference of either:
* IV methotrexate (0.4 mg/kg) daily for 5 days every 14 days. (25mg max daily dose) OR
* IM methotrexate (50mg) on Days 1, 3, 5, 7 (4 doses per cycle) with Leucovorin (15mg) on Days 2, 4, 6, 8. Repeat every 14 days.
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
28
|
|
Overall Study
COMPLETED
|
28
|
26
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Regimen I (Dactinomycin)
IV pulse actinomycin-D (1.25mg/m2 ) every 14 days. (2mg max dose)
|
Regimen II (Methotrexate)
institutional preference of either:
* IV methotrexate (0.4 mg/kg) daily for 5 days every 14 days. (25mg max daily dose) OR
* IM methotrexate (50mg) on Days 1, 3, 5, 7 (4 doses per cycle) with Leucovorin (15mg) on Days 2, 4, 6, 8. Repeat every 14 days.
|
|---|---|---|
|
Overall Study
Ineligible
|
1
|
2
|
Baseline Characteristics
Dactinomycin or Methotrexate in Treating Patients With Low-Risk Gestational Trophoblastic Neoplasia
Baseline characteristics by cohort
| Measure |
Regimen I (Dactinomycin)
n=28 Participants
IV pulse actinomycin-D (1.25mg/m2 ) every 14 days. (2mg max dose)
|
Regimen II (Methotrexate)
n=26 Participants
institutional preference of either:
* IV methotrexate (0.4 mg/kg) daily for 5 days every 14 days. (25mg max daily dose) OR
* IM methotrexate (50mg) on Days 1, 3, 5, 7 (4 doses per cycle) with Leucovorin (15mg) on Days 2, 4, 6, 8. Repeat every 14 days.
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
10-19 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Customized
20-29 years
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Age, Customized
30-39 years
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Age, Customized
40-49 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
26 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 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
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
35 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: hCG testing is performed prior to each cycle to treatment until treatment is completed, up to 10 months. For patients who have responded to treatment hCG must be obtained every 4 weeks for 1 year after completing treatment.Population: Eligible patients
Complete Response is defined as 3 consecutive bi-weekly values of hCG\<5 over a minimum of 4 weeks of normal hCG values with no values greater than 5 mIU/ml
Outcome measures
| Measure |
Regimen I (Dactinomycin)
n=28 Participants
IV pulse actinomycin-D (1.25mg/m2 ) every 14 days. (2mg max dose)
|
Regimen II (Methotrexate)
n=26 Participants
institutional preference of either:
* IV methotrexate (0.4 mg/kg) daily for 5 days every 14 days. (25mg max daily dose) OR
* IM methotrexate (50mg) on Days 1, 3, 5, 7 (4 doses per cycle) with Leucovorin (15mg) on Days 2, 4, 6, 8. Repeat every 14 days.
|
|---|---|---|
|
Percentage of Participants With Complete Response
|
78.6 percentage of participants
Interval 59.0 to 91.7
|
88.5 percentage of participants
Interval 69.8 to 97.6
|
SECONDARY outcome
Timeframe: Assessed throughout the treatment period and within 2-4 weeks after discontinuation of treatmentPopulation: Eligible and treated patients
Maximum grade of physician assessed adverse events reported during treatment
Outcome measures
| Measure |
Regimen I (Dactinomycin)
n=28 Participants
IV pulse actinomycin-D (1.25mg/m2 ) every 14 days. (2mg max dose)
|
Regimen II (Methotrexate)
n=26 Participants
institutional preference of either:
* IV methotrexate (0.4 mg/kg) daily for 5 days every 14 days. (25mg max daily dose) OR
* IM methotrexate (50mg) on Days 1, 3, 5, 7 (4 doses per cycle) with Leucovorin (15mg) on Days 2, 4, 6, 8. Repeat every 14 days.
|
|---|---|---|
|
Number of Participants With CTCAE v4 Graded Adverse Events With Low-risk Gestational Trophoblastic Neoplasia by Arm
Grade 1
|
7 participants
|
4 participants
|
|
Number of Participants With CTCAE v4 Graded Adverse Events With Low-risk Gestational Trophoblastic Neoplasia by Arm
Grade 2
|
14 participants
|
10 participants
|
|
Number of Participants With CTCAE v4 Graded Adverse Events With Low-risk Gestational Trophoblastic Neoplasia by Arm
Grade 3
|
6 participants
|
10 participants
|
|
Number of Participants With CTCAE v4 Graded Adverse Events With Low-risk Gestational Trophoblastic Neoplasia by Arm
Grade 4
|
0 participants
|
0 participants
|
|
Number of Participants With CTCAE v4 Graded Adverse Events With Low-risk Gestational Trophoblastic Neoplasia by Arm
Grade 5
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Anytime during post treatment follow-up for up to 2 years from study entry.Population: Non-responding eligible patients in follow-up
Outcome measures
| Measure |
Regimen I (Dactinomycin)
n=7 Participants
IV pulse actinomycin-D (1.25mg/m2 ) every 14 days. (2mg max dose)
|
Regimen II (Methotrexate)
n=5 Participants
institutional preference of either:
* IV methotrexate (0.4 mg/kg) daily for 5 days every 14 days. (25mg max daily dose) OR
* IM methotrexate (50mg) on Days 1, 3, 5, 7 (4 doses per cycle) with Leucovorin (15mg) on Days 2, 4, 6, 8. Repeat every 14 days.
|
|---|---|---|
|
The Number of Participants With Post Protocol Surgical Treatment for Each Arm.
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Anytime during post treatment follow-up for up to 2 years from study entry.Population: Non-responding eligible patients in follow-up
Outcome measures
| Measure |
Regimen I (Dactinomycin)
n=7 Participants
IV pulse actinomycin-D (1.25mg/m2 ) every 14 days. (2mg max dose)
|
Regimen II (Methotrexate)
n=5 Participants
institutional preference of either:
* IV methotrexate (0.4 mg/kg) daily for 5 days every 14 days. (25mg max daily dose) OR
* IM methotrexate (50mg) on Days 1, 3, 5, 7 (4 doses per cycle) with Leucovorin (15mg) on Days 2, 4, 6, 8. Repeat every 14 days.
|
|---|---|---|
|
The Number of Participants With Post Protocol Multi-agent Chemotherapy Treatment for Each Arm.
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Prior to cycle 1Population: Provided baseline QOL questionnaire
Patient reported quality of life was measured with the Functional Assessment of Cancer Therapy - Generic (FACT-G). The FACT-G is a scale for assessing general QOL of cancer patients. It consists of four subscales: Physical Well Being, Functional Well Being, Social/Family Well-Being, and Emotional Well-Being. Each item in the FACT-G was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative statements, reversal was performed prior to score calculation. According to the FACIT measurement system, a subscale score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the subscale. The FACT-G score is calculated as the sum of the subscale scores. The FACT-G score ranges 0-108. A larger score suggests better QOL.
Outcome measures
| Measure |
Regimen I (Dactinomycin)
n=27 Participants
IV pulse actinomycin-D (1.25mg/m2 ) every 14 days. (2mg max dose)
|
Regimen II (Methotrexate)
n=27 Participants
institutional preference of either:
* IV methotrexate (0.4 mg/kg) daily for 5 days every 14 days. (25mg max daily dose) OR
* IM methotrexate (50mg) on Days 1, 3, 5, 7 (4 doses per cycle) with Leucovorin (15mg) on Days 2, 4, 6, 8. Repeat every 14 days.
|
|---|---|---|
|
Patient-reported Quality of Life (QOL) at Baseline
|
82.3 units on a scale
Standard Error 2.7
|
81.9 units on a scale
Standard Error 3.3
|
SECONDARY outcome
Timeframe: Prior to cycle 3 (4 weeks after cycle 1 if off study treatment prior to cycle 3). Prior to cycle 5, Prior to cycle 7, 26 weeks after starting study treatment.Population: Provided baseline and ≥1 follow-up assessments
Patient reported quality of life was measured with the Functional Assessment of Cancer Therapy - Generic (FACT-G). The FACT-G is a scale for assessing general QOL of cancer patients. It consists of four subscales: Physical Well Being, Functional Well Being, Social/Family Well-Being, and Emotional Well-Being. Each item in the FACT-G was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative statements, reversal was performed prior to score calculation. According to the FACIT measurement system, a subscale score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the subscale. The FACT-G score is calculated as the sum of the subscale scores. The FACT-G score ranges 0-108. A larger score suggests better QOL.
Outcome measures
| Measure |
Regimen I (Dactinomycin)
n=27 Participants
IV pulse actinomycin-D (1.25mg/m2 ) every 14 days. (2mg max dose)
|
Regimen II (Methotrexate)
n=27 Participants
institutional preference of either:
* IV methotrexate (0.4 mg/kg) daily for 5 days every 14 days. (25mg max daily dose) OR
* IM methotrexate (50mg) on Days 1, 3, 5, 7 (4 doses per cycle) with Leucovorin (15mg) on Days 2, 4, 6, 8. Repeat every 14 days.
|
|---|---|---|
|
Patient-reported Quality of Life (QOL) After Baseline Visit.
Pre-cycle 3
|
78.3 units on a scale
Standard Error 2.3
|
81.6 units on a scale
Standard Error 2.7
|
|
Patient-reported Quality of Life (QOL) After Baseline Visit.
Pre-cycle 5
|
75.5 units on a scale
Standard Error 3.3
|
78.9 units on a scale
Standard Error 2.8
|
|
Patient-reported Quality of Life (QOL) After Baseline Visit.
Pre-cycle 7
|
85.0 units on a scale
Standard Error 2.7
|
84.5 units on a scale
Standard Error 2.2
|
|
Patient-reported Quality of Life (QOL) After Baseline Visit.
26 weeks
|
91.2 units on a scale
Standard Error 2.9
|
90.9 units on a scale
Standard Error 2.9
|
Adverse Events
Regimen I (Dactinomycin)
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
Regimen II (Methotrexate)
Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Regimen I (Dactinomycin)
n=28 participants at risk
IV pulse actinomycin-D (1.25mg/m2 ) every 14 days. (2mg max dose)
|
Regimen II (Methotrexate)
n=26 participants at risk
institutional preference of either:
* IV methotrexate (0.4 mg/kg) daily for 5 days every 14 days. (25mg max daily dose) OR
* IM methotrexate (50mg) on Days 1, 3, 5, 7 (4 doses per cycle) with Leucovorin (15mg) on Days 2, 4, 6, 8. Repeat every 14 days.
|
|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
3.8%
1/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Psychiatric disorders
Psychiatric Disorders - Other
|
3.6%
1/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
0.00%
0/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
Other adverse events
| Measure |
Regimen I (Dactinomycin)
n=28 participants at risk
IV pulse actinomycin-D (1.25mg/m2 ) every 14 days. (2mg max dose)
|
Regimen II (Methotrexate)
n=26 participants at risk
institutional preference of either:
* IV methotrexate (0.4 mg/kg) daily for 5 days every 14 days. (25mg max daily dose) OR
* IM methotrexate (50mg) on Days 1, 3, 5, 7 (4 doses per cycle) with Leucovorin (15mg) on Days 2, 4, 6, 8. Repeat every 14 days.
|
|---|---|---|
|
Investigations
Alanine Aminotransferase Increased
|
7.1%
2/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
3.8%
1/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
7.7%
2/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.6%
1/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
0.00%
0/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
7.1%
2/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
0.00%
0/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
10.7%
3/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
0.00%
0/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
3.6%
1/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
7.7%
2/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Immune system disorders
Allergic Reaction
|
0.00%
0/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
3.8%
1/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Infections and infestations
Infections And Infestations - Other
|
14.3%
4/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
3.8%
1/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Infections and infestations
Upper Respiratory Infection
|
0.00%
0/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
3.8%
1/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Infections and infestations
Vulval Infection
|
0.00%
0/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
3.8%
1/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Infections and infestations
Skin Infection
|
3.6%
1/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
7.7%
2/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
3.8%
1/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Infections and infestations
Vaginal Infection
|
0.00%
0/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
7.7%
2/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Infections and infestations
Urinary Tract Infection
|
3.6%
1/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
3.8%
1/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Injury, poisoning and procedural complications
Bruising
|
3.6%
1/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
0.00%
0/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Investigations
Investigations - Other
|
3.6%
1/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
0.00%
0/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Investigations
Weight Gain
|
0.00%
0/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
7.7%
2/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Investigations
Platelet Count Decreased
|
10.7%
3/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
15.4%
4/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Investigations
Hemoglobin Increased
|
3.6%
1/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
0.00%
0/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Investigations
Ggt Increased
|
3.6%
1/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
3.8%
1/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Investigations
Neutrophil Count Decreased
|
17.9%
5/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
26.9%
7/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Investigations
White Blood Cell Decreased
|
14.3%
4/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
23.1%
6/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Investigations
Aspartate Aminotransferase Increased
|
7.1%
2/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
3.8%
1/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Investigations
Alkaline Phosphatase Increased
|
3.6%
1/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
0.00%
0/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Gastrointestinal disorders
Oral Dysesthesia
|
3.6%
1/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
0.00%
0/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Gastrointestinal disorders
Mucositis Oral
|
42.9%
12/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
76.9%
20/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Gastrointestinal disorders
Gastrointestinal Disorders - Other
|
0.00%
0/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
3.8%
1/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Gastrointestinal disorders
Gingival Pain
|
3.6%
1/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
3.8%
1/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Gastrointestinal disorders
Nausea
|
71.4%
20/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
61.5%
16/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
10.7%
3/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
3.8%
1/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
General disorders
General Disorders And Administration Site Conditio
|
10.7%
3/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
0.00%
0/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
General disorders
Pain
|
0.00%
0/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
7.7%
2/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
General disorders
Malaise
|
10.7%
3/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
3.8%
1/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
General disorders
Localized Edema
|
0.00%
0/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
3.8%
1/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
General disorders
Flu Like Symptoms
|
3.6%
1/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
7.7%
2/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
General disorders
Non-Cardiac Chest Pain
|
3.6%
1/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
0.00%
0/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
General disorders
Edema Limbs
|
3.6%
1/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
0.00%
0/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
General disorders
Edema Face
|
0.00%
0/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
3.8%
1/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
General disorders
Fatigue
|
64.3%
18/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
57.7%
15/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
General disorders
Fever
|
7.1%
2/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
3.8%
1/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
General disorders
Chills
|
3.6%
1/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
3.8%
1/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Blood and lymphatic system disorders
Lymph Node Pain
|
0.00%
0/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
3.8%
1/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Blood and lymphatic system disorders
Blood And Lymphatic System Disorders - Other
|
3.6%
1/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
11.5%
3/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Blood and lymphatic system disorders
Anemia
|
46.4%
13/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
57.7%
15/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Cardiac disorders
Palpitations
|
3.6%
1/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
3.8%
1/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Cardiac disorders
Cardiac Disorders - Other
|
0.00%
0/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
3.8%
1/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Ear and labyrinth disorders
Tinnitus
|
3.6%
1/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
15.4%
4/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Ear and labyrinth disorders
Hearing Impaired
|
0.00%
0/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
3.8%
1/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Ear and labyrinth disorders
Ear Pain
|
7.1%
2/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
0.00%
0/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Eye disorders
Eye Disorders - Other
|
0.00%
0/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
11.5%
3/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Eye disorders
Watering Eyes
|
0.00%
0/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
15.4%
4/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Eye disorders
Eye Pain
|
3.6%
1/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
0.00%
0/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Eye disorders
Photophobia
|
0.00%
0/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
3.8%
1/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Eye disorders
Blurred Vision
|
14.3%
4/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
11.5%
3/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Eye disorders
Dry Eye
|
0.00%
0/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
15.4%
4/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Gastrointestinal disorders
Dysphagia
|
3.6%
1/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
11.5%
3/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
3.8%
1/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Gastrointestinal disorders
Constipation
|
42.9%
12/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
42.3%
11/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
7/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
26.9%
7/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Gastrointestinal disorders
Vomiting
|
28.6%
8/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
23.1%
6/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Gastrointestinal disorders
Stomach Pain
|
0.00%
0/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
7.7%
2/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Gastrointestinal disorders
Abdominal Pain
|
35.7%
10/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
23.1%
6/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
3.6%
1/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
7.7%
2/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
14.3%
4/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
3.8%
1/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Metabolism and nutrition disorders
Anorexia
|
14.3%
4/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
26.9%
7/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
3.6%
1/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
3.8%
1/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.7%
3/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
3.8%
1/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
7.1%
2/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
0.00%
0/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
7.1%
2/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
3.8%
1/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.6%
1/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
0.00%
0/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal And Connective Tissue Disorder - O
|
0.00%
0/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
3.8%
1/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
3.6%
1/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
0.00%
0/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Nervous system disorders
Peripheral Motor Neuropathy
|
3.6%
1/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
0.00%
0/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Nervous system disorders
Paresthesia
|
3.6%
1/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
3.8%
1/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Nervous system disorders
Headache
|
28.6%
8/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
19.2%
5/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Nervous system disorders
Facial Muscle Weakness
|
3.6%
1/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
0.00%
0/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Nervous system disorders
Dysgeusia
|
3.6%
1/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
0.00%
0/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Nervous system disorders
Syncope
|
3.6%
1/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
0.00%
0/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Nervous system disorders
Dizziness
|
7.1%
2/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
0.00%
0/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Psychiatric disorders
Psychiatric Disorders - Other
|
3.6%
1/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
0.00%
0/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
3.8%
1/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Psychiatric disorders
Personality Change
|
3.6%
1/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
0.00%
0/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Psychiatric disorders
Insomnia
|
3.6%
1/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
23.1%
6/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Psychiatric disorders
Depression
|
3.6%
1/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
3.8%
1/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
3.8%
1/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Psychiatric disorders
Anxiety
|
7.1%
2/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
7.7%
2/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Renal and urinary disorders
Urinary Retention
|
3.6%
1/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
0.00%
0/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Renal and urinary disorders
Urinary Tract Pain
|
3.6%
1/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
0.00%
0/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Renal and urinary disorders
Urinary Frequency
|
3.6%
1/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
0.00%
0/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
3.8%
1/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Renal and urinary disorders
Hematuria
|
3.6%
1/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
11.5%
3/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Reproductive system and breast disorders
Reproductive System And Breast Disorders - Other
|
3.6%
1/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
0.00%
0/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Reproductive system and breast disorders
Vaginal Hemorrhage
|
21.4%
6/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
26.9%
7/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Reproductive system and breast disorders
Vaginal Dryness
|
0.00%
0/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
3.8%
1/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Reproductive system and breast disorders
Perineal Pain
|
3.6%
1/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
0.00%
0/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Reproductive system and breast disorders
Pelvic Pain
|
3.6%
1/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
3.8%
1/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Reproductive system and breast disorders
Menorrhagia
|
7.1%
2/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
0.00%
0/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Reproductive system and breast disorders
Irregular Menstruation
|
3.6%
1/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
0.00%
0/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
17.9%
5/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
11.5%
3/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Reproductive system and breast disorders
Vaginal Inflammation
|
0.00%
0/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
3.8%
1/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
3.6%
1/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
0.00%
0/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
3.6%
1/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
0.00%
0/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic Pain
|
0.00%
0/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
11.5%
3/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
17.9%
5/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
15.4%
4/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
4/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
7.7%
2/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
3.6%
1/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
3.8%
1/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Skin And Subcutaneous Tissue Disorders - Other
|
7.1%
2/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
7.7%
2/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
3.6%
1/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
0.00%
0/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Skin Ulceration
|
0.00%
0/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
3.8%
1/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Skin Hyperpigmentation
|
3.6%
1/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
0.00%
0/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Rash Acneiform
|
7.1%
2/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
3.8%
1/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
11.5%
3/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
3.6%
1/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
3.8%
1/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
10.7%
3/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
11.5%
3/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
3.6%
1/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
11.5%
3/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
25.0%
7/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
19.2%
5/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Vascular disorders
Thromboembolic Event
|
3.6%
1/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
0.00%
0/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Vascular disorders
Phlebitis
|
3.6%
1/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
0.00%
0/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Vascular disorders
Hypotension
|
0.00%
0/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
3.8%
1/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Vascular disorders
Hypertension
|
3.6%
1/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
3.8%
1/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Vascular disorders
Hot Flashes
|
10.7%
3/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
3.8%
1/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
|
Vascular disorders
Flushing
|
0.00%
0/28 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
7.7%
2/26 • Through Study Treatment and up to 30 days after discontinuing treatment.
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60