Trial Outcomes & Findings for Intensity-Modulated Radiation Therapy, Cisplatin, and Bevacizumab Followed by Carboplatin and Paclitaxel in Treating Patients Who Have Undergone Surgery for Endometrial Cancer (NCT NCT01005329)
NCT ID: NCT01005329
Last Updated: 2018-03-15
Results Overview
Adverse events are graded using CTCAE v4.0. Grade refers to the severity of the AE, assigning Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
34 participants
Primary outcome timeframe
From start of treatment to 90 days
Results posted on
2018-03-15
Participant Flow
Participant milestones
| Measure |
Chemoradiation (IMRT), Chemotherapy
Pelvic intensity-modulated radiation therapy (IMRT) once daily, 5 days a week, for 5 weeks (45 Gy in 25 fractions) with optional nodal boost radiotherapy and/or vaginal brachytherapy boost. Concurrent cisplatin (CISPT) 50 mg/m\^2 IV over 1 hour on days 1 and 29 and bevacizumab (BEV) 5mg/kg IV over 30-90 minutes on days 1, 15, and 29. Beginning 4-6 weeks after completing IMRT, cisplatin, and bevacizumab, patients receive carboplatin (CBCDA) IV area under the curve (AUC) 5 over 1 hour and paclitaxel (PTX) IV 135 mg/m\^2 over 3 hours on day 1 and every every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
34
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Chemoradiation (IMRT), Chemotherapy
Pelvic intensity-modulated radiation therapy (IMRT) once daily, 5 days a week, for 5 weeks (45 Gy in 25 fractions) with optional nodal boost radiotherapy and/or vaginal brachytherapy boost. Concurrent cisplatin (CISPT) 50 mg/m\^2 IV over 1 hour on days 1 and 29 and bevacizumab (BEV) 5mg/kg IV over 30-90 minutes on days 1, 15, and 29. Beginning 4-6 weeks after completing IMRT, cisplatin, and bevacizumab, patients receive carboplatin (CBCDA) IV area under the curve (AUC) 5 over 1 hour and paclitaxel (PTX) IV 135 mg/m\^2 over 3 hours on day 1 and every every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
Ineligible or received no protocol trt.
|
4
|
Baseline Characteristics
Intensity-Modulated Radiation Therapy, Cisplatin, and Bevacizumab Followed by Carboplatin and Paclitaxel in Treating Patients Who Have Undergone Surgery for Endometrial Cancer
Baseline characteristics by cohort
| Measure |
Chemoradiation (IMRT), Chemotherapy
n=30 Participants
Pelvic intensity-modulated radiation therapy (IMRT) once daily, 5 days a week, for 5 weeks (45 Gy in 25 fractions) with optional nodal boost radiotherapy and/or vaginal brachytherapy boost. Concurrent cisplatin (CISPT) 50 mg/m\^2 IV over 1 hour on days 1 and 29 and bevacizumab (BEV) 5mg/kg IV over 30-90 minutes on days 1, 15, and 29. Beginning 4-6 weeks after completing IMRT, cisplatin, and bevacizumab, patients receive carboplatin (CBCDA) IV AUC 5 over 1 hour and paclitaxel (PTX) IV 135 mg/m\^2 over 3 hours on day 1 and every every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Continuous
|
59 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From start of treatment to 90 daysPopulation: Eligible patients who started study treatment
Adverse events are graded using CTCAE v4.0. Grade refers to the severity of the AE, assigning Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.
Outcome measures
| Measure |
Chemoradiation (IMRT), Chemotherapy
n=30 Participants
Pelvic intensity-modulated radiation therapy (IMRT) once daily, 5 days a week, for 5 weeks (45 Gy in 25 fractions) with optional nodal boost radiotherapy and/or vaginal brachytherapy boost. Concurrent cisplatin (CISPT) 50 mg/m\^2 IV over 1 hour on days 1 and 29 and bevacizumab (BEV) 5mg/kg IV over 30-90 minutes on days 1, 15, and 29. Beginning 4-6 weeks after completing IMRT, cisplatin, and bevacizumab, patients receive carboplatin (CBCDA) IV AUC 5 over 1 hour and paclitaxel (PTX) IV 135 mg/m\^2 over 3 hours on day 1 and every every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Percentage of Participants With Treatment-related, Grade 3+, Non-hematologic Adverse Events Occuring Within 90 Days After Treatment Start
|
23.3 percentage of participants
Interval 10.63 to 36.0
|
SECONDARY outcome
Timeframe: From start of treatment to one yearPopulation: Eligible patients who started study treatment
Adverse events are graded using CTCAE v4.0. Grade refers to the severity of the AE, assigning Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. Adverse events reported as definitely, probably, or possibly related to study treatment.
Outcome measures
| Measure |
Chemoradiation (IMRT), Chemotherapy
n=30 Participants
Pelvic intensity-modulated radiation therapy (IMRT) once daily, 5 days a week, for 5 weeks (45 Gy in 25 fractions) with optional nodal boost radiotherapy and/or vaginal brachytherapy boost. Concurrent cisplatin (CISPT) 50 mg/m\^2 IV over 1 hour on days 1 and 29 and bevacizumab (BEV) 5mg/kg IV over 30-90 minutes on days 1, 15, and 29. Beginning 4-6 weeks after completing IMRT, cisplatin, and bevacizumab, patients receive carboplatin (CBCDA) IV AUC 5 over 1 hour and paclitaxel (PTX) IV 135 mg/m\^2 over 3 hours on day 1 and every every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Percentage of Participants With Treatment-related, Grade 3+, Non-hematologic Adverse Events Occuring Within 1 Year After Treatment Start
|
43.3 percentage of participants
Interval 28.5 to 58.2
|
SECONDARY outcome
Timeframe: From start of treatment to end of follow-up, up to 43.4 months; analysis occurred after all patients had been on study for at least one year.Population: Eligible patients who started treatment
The highest grade adverse event per patient reported as definitely, probably, or possibly related to study treatment is counted. Adverse events are graded using CTCAE v4.0. Grade refers to the severity of the AE, assigning Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.
Outcome measures
| Measure |
Chemoradiation (IMRT), Chemotherapy
n=30 Participants
Pelvic intensity-modulated radiation therapy (IMRT) once daily, 5 days a week, for 5 weeks (45 Gy in 25 fractions) with optional nodal boost radiotherapy and/or vaginal brachytherapy boost. Concurrent cisplatin (CISPT) 50 mg/m\^2 IV over 1 hour on days 1 and 29 and bevacizumab (BEV) 5mg/kg IV over 30-90 minutes on days 1, 15, and 29. Beginning 4-6 weeks after completing IMRT, cisplatin, and bevacizumab, patients receive carboplatin (CBCDA) IV AUC 5 over 1 hour and paclitaxel (PTX) IV 135 mg/m\^2 over 3 hours on day 1 and every every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Treatment-related Grade 3+ Adverse Events
Grade 0
|
1 Participants
|
|
Treatment-related Grade 3+ Adverse Events
Grade 1
|
0 Participants
|
|
Treatment-related Grade 3+ Adverse Events
Grade 2
|
8 Participants
|
|
Treatment-related Grade 3+ Adverse Events
Grade 3
|
12 Participants
|
|
Treatment-related Grade 3+ Adverse Events
Grade 4
|
9 Participants
|
|
Treatment-related Grade 3+ Adverse Events
Grade 5
|
0 Participants
|
SECONDARY outcome
Timeframe: From registration to two yearsPopulation: Eligible patients who started study treatment
Failure was defined as death due to any cause. Patients alive at time of analysis were censored at the date of last contact. Survival rate at two years was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Chemoradiation (IMRT), Chemotherapy
n=30 Participants
Pelvic intensity-modulated radiation therapy (IMRT) once daily, 5 days a week, for 5 weeks (45 Gy in 25 fractions) with optional nodal boost radiotherapy and/or vaginal brachytherapy boost. Concurrent cisplatin (CISPT) 50 mg/m\^2 IV over 1 hour on days 1 and 29 and bevacizumab (BEV) 5mg/kg IV over 30-90 minutes on days 1, 15, and 29. Beginning 4-6 weeks after completing IMRT, cisplatin, and bevacizumab, patients receive carboplatin (CBCDA) IV AUC 5 over 1 hour and paclitaxel (PTX) IV 135 mg/m\^2 over 3 hours on day 1 and every every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Survival (Two-year Rate Reported)
|
96.7 percentage of participants
Interval 78.6 to 99.5
|
SECONDARY outcome
Timeframe: From registration to two yearsPopulation: Eligible patients who started study treatment
Failure was defined as pelvic failure (recurrence in the pelvis, which must be confirmed by histologic or cytologic biopsy of the recurrent lesion), distant failure (confirmed by histologic or cytologic biopsy of the recurrent lesion), or death due to any cause. Patients alive at time of analysis were censored at the date of last contact. Disease-free survival rate at two years was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Chemoradiation (IMRT), Chemotherapy
n=30 Participants
Pelvic intensity-modulated radiation therapy (IMRT) once daily, 5 days a week, for 5 weeks (45 Gy in 25 fractions) with optional nodal boost radiotherapy and/or vaginal brachytherapy boost. Concurrent cisplatin (CISPT) 50 mg/m\^2 IV over 1 hour on days 1 and 29 and bevacizumab (BEV) 5mg/kg IV over 30-90 minutes on days 1, 15, and 29. Beginning 4-6 weeks after completing IMRT, cisplatin, and bevacizumab, patients receive carboplatin (CBCDA) IV AUC 5 over 1 hour and paclitaxel (PTX) IV 135 mg/m\^2 over 3 hours on day 1 and every every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Disease-free Survival (Two-year Rate Reported)
|
79.1 percentage of participants
Interval 59.2 to 90.1
|
SECONDARY outcome
Timeframe: From registration to two yearsPopulation: Eligible patients who started study treatment
Pelvic failure (PF) was defined as disease recurrence in the pelvis, including the pelvic or sacral lymph nodes, and required confirmation by histologic or cytologic biopsy of the recurrent lesion. Death was considered a competing risk. PF rates were estimated using the cumulative incidence method.
Outcome measures
| Measure |
Chemoradiation (IMRT), Chemotherapy
n=30 Participants
Pelvic intensity-modulated radiation therapy (IMRT) once daily, 5 days a week, for 5 weeks (45 Gy in 25 fractions) with optional nodal boost radiotherapy and/or vaginal brachytherapy boost. Concurrent cisplatin (CISPT) 50 mg/m\^2 IV over 1 hour on days 1 and 29 and bevacizumab (BEV) 5mg/kg IV over 30-90 minutes on days 1, 15, and 29. Beginning 4-6 weeks after completing IMRT, cisplatin, and bevacizumab, patients receive carboplatin (CBCDA) IV AUC 5 over 1 hour and paclitaxel (PTX) IV 135 mg/m\^2 over 3 hours on day 1 and every every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Pelvic Failure Rate (Two-year Rate Reported)
|
0 percentage of participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: From registration to two yearsPopulation: Eligible patients who started study treatment
Distant Failure (DF) was defined as the appearance of distant metastasis. Death was considered a competing risk. DF rates were estimated using the cumulative incidence method.
Outcome measures
| Measure |
Chemoradiation (IMRT), Chemotherapy
n=30 Participants
Pelvic intensity-modulated radiation therapy (IMRT) once daily, 5 days a week, for 5 weeks (45 Gy in 25 fractions) with optional nodal boost radiotherapy and/or vaginal brachytherapy boost. Concurrent cisplatin (CISPT) 50 mg/m\^2 IV over 1 hour on days 1 and 29 and bevacizumab (BEV) 5mg/kg IV over 30-90 minutes on days 1, 15, and 29. Beginning 4-6 weeks after completing IMRT, cisplatin, and bevacizumab, patients receive carboplatin (CBCDA) IV AUC 5 over 1 hour and paclitaxel (PTX) IV 135 mg/m\^2 over 3 hours on day 1 and every every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Distant Failure (Two-year Rate Reported)
|
17.0 percentage of participants
Interval 3.2 to 30.9
|
Adverse Events
Chemoradiation (IMRT), Chemotherapy
Serious events: 8 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Chemoradiation (IMRT), Chemotherapy
n=30 participants at risk
Pelvic intensity-modulated radiation therapy (IMRT) once daily, 5 days a week, for 5 weeks (45 Gy in 25 fractions) with optional nodal boost radiotherapy and/or vaginal brachytherapy boost. Concurrent cisplatin (CISPT) 50 mg/m\^2 IV over 1 hour on days 1 and 29 and bevacizumab (BEV) 5mg/kg IV over 30-90 minutes on days 1, 15, and 29. Beginning 4-6 weeks after completing IMRT, cisplatin, and bevacizumab, patients receive carboplatin (CBCDA) IV AUC 5 over 1 hour and paclitaxel (PTX) IV 135 mg/m\^2 over 3 hours on day 1 and every every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
6.7%
2/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Diarrhea
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Esophageal pain
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Infections and infestations
Skin infection
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Infections and infestations
Urinary tract infection
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Investigations
Lymphocyte count decreased
|
6.7%
2/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Investigations
Neutrophil count decreased
|
6.7%
2/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Investigations
Platelet count decreased
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Investigations
White blood cell decreased
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Nervous system disorders
Neuralgia
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Vascular disorders
Thromboembolic event
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
Other adverse events
| Measure |
Chemoradiation (IMRT), Chemotherapy
n=30 participants at risk
Pelvic intensity-modulated radiation therapy (IMRT) once daily, 5 days a week, for 5 weeks (45 Gy in 25 fractions) with optional nodal boost radiotherapy and/or vaginal brachytherapy boost. Concurrent cisplatin (CISPT) 50 mg/m\^2 IV over 1 hour on days 1 and 29 and bevacizumab (BEV) 5mg/kg IV over 30-90 minutes on days 1, 15, and 29. Beginning 4-6 weeks after completing IMRT, cisplatin, and bevacizumab, patients receive carboplatin (CBCDA) IV AUC 5 over 1 hour and paclitaxel (PTX) IV 135 mg/m\^2 over 3 hours on day 1 and every every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Metabolism and nutrition disorders
Anorexia
|
36.7%
11/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Metabolism and nutrition disorders
Dehydration
|
13.3%
4/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
10.0%
3/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
10.0%
3/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
13.3%
4/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
63.3%
19/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
10.0%
3/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
23.3%
7/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
16.7%
5/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
20.0%
6/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
50.0%
15/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
20.0%
6/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
6.7%
2/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
6.7%
2/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
3/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
23.3%
7/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.7%
2/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Blood and lymphatic system disorders
Anemia
|
73.3%
22/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
6.7%
2/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Cardiac disorders
Chest pain - cardiac
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Cardiac disorders
Palpitations
|
6.7%
2/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Cardiac disorders
Sinus tachycardia
|
6.7%
2/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Ear and labyrinth disorders
Ear pain
|
10.0%
3/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Ear and labyrinth disorders
Hearing impaired
|
13.3%
4/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Ear and labyrinth disorders
Tinnitus
|
16.7%
5/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Eye disorders
Blurred vision
|
26.7%
8/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Eye disorders
Eye disorders - Other, specify
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Eye disorders
Eye pain
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Eye disorders
Floaters
|
6.7%
2/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Eye disorders
Photophobia
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Abdominal pain
|
30.0%
9/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Anal mucositis
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Anal pain
|
10.0%
3/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Bloating
|
23.3%
7/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Constipation
|
60.0%
18/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Dental caries
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Diarrhea
|
73.3%
22/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Dry mouth
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Dyspepsia
|
23.3%
7/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Dysphagia
|
6.7%
2/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Esophageal pain
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Fecal incontinence
|
6.7%
2/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Flatulence
|
6.7%
2/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
6.7%
2/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
6.7%
2/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Hemorrhoids
|
10.0%
3/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Mucositis oral
|
16.7%
5/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Nausea
|
63.3%
19/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Proctitis
|
10.0%
3/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
13.3%
4/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Rectal pain
|
10.0%
3/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Salivary duct inflammation
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Vomiting
|
36.7%
11/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
General disorders
Chills
|
10.0%
3/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
General disorders
Edema face
|
6.7%
2/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
General disorders
Edema limbs
|
26.7%
8/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
General disorders
Fatigue
|
86.7%
26/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
General disorders
Fever
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
General disorders
Flu like symptoms
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
General disorders
Gait disturbance
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
10.0%
3/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
General disorders
Localized edema
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
General disorders
Pain
|
16.7%
5/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Infections and infestations
Bladder infection
|
6.7%
2/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Infections and infestations
Infections and infestations - Other, specify
|
6.7%
2/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Infections and infestations
Lung infection
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Infections and infestations
Skin infection
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Infections and infestations
Tooth infection
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Infections and infestations
Upper respiratory infection
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Infections and infestations
Urethral infection
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Infections and infestations
Urinary tract infection
|
13.3%
4/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Infections and infestations
Vaginal infection
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Infections and infestations
Wound infection
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
16.7%
5/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Injury, poisoning and procedural complications
Radiation recall reaction (dermatologic)
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Investigations
Alanine aminotransferase increased
|
20.0%
6/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Investigations
Alkaline phosphatase increased
|
10.0%
3/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Investigations
Aspartate aminotransferase increased
|
20.0%
6/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Investigations
Blood bilirubin increased
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Investigations
Cholesterol high
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Investigations
Creatinine increased
|
16.7%
5/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Investigations
GGT increased
|
6.7%
2/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Investigations
Hemoglobin increased
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Investigations
Investigations - Other, specify
|
20.0%
6/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Investigations
Lymphocyte count decreased
|
63.3%
19/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Investigations
Lymphocyte count increased
|
6.7%
2/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Investigations
Neutrophil count decreased
|
56.7%
17/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Investigations
Platelet count decreased
|
53.3%
16/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Investigations
Weight gain
|
6.7%
2/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Investigations
Weight loss
|
20.0%
6/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Investigations
White blood cell decreased
|
76.7%
23/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.0%
6/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
23.3%
7/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Nervous system disorders
Cognitive disturbance
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Nervous system disorders
Concentration impairment
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Nervous system disorders
Dizziness
|
20.0%
6/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Nervous system disorders
Dysgeusia
|
10.0%
3/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Nervous system disorders
Extrapyramidal disorder
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Nervous system disorders
Headache
|
40.0%
12/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Nervous system disorders
Neuralgia
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Nervous system disorders
Paresthesia
|
16.7%
5/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Nervous system disorders
Peripheral motor neuropathy
|
13.3%
4/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
46.7%
14/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Nervous system disorders
Syncope
|
6.7%
2/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Psychiatric disorders
Agitation
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Psychiatric disorders
Anxiety
|
23.3%
7/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Psychiatric disorders
Depression
|
23.3%
7/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Psychiatric disorders
Insomnia
|
16.7%
5/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Renal and urinary disorders
Acute kidney injury
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Renal and urinary disorders
Bladder spasm
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Renal and urinary disorders
Cystitis noninfective
|
10.0%
3/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Renal and urinary disorders
Hematuria
|
6.7%
2/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
16.7%
5/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Renal and urinary disorders
Urinary frequency
|
26.7%
8/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Renal and urinary disorders
Urinary incontinence
|
16.7%
5/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Renal and urinary disorders
Urinary retention
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Renal and urinary disorders
Urinary tract pain
|
26.7%
8/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Renal and urinary disorders
Urinary urgency
|
16.7%
5/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Reproductive system and breast disorders
Breast pain
|
6.7%
2/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Reproductive system and breast disorders
Dyspareunia
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Reproductive system and breast disorders
Pelvic pain
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Reproductive system and breast disorders
Vaginal discharge
|
20.0%
6/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Reproductive system and breast disorders
Vaginal dryness
|
23.3%
7/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
13.3%
4/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Reproductive system and breast disorders
Vaginal inflammation
|
10.0%
3/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Reproductive system and breast disorders
Vaginal pain
|
10.0%
3/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Reproductive system and breast disorders
Vaginal stricture
|
10.0%
3/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Reproductive system and breast disorders
Vaginismus
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
23.3%
7/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
26.7%
8/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
13.3%
4/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
56.7%
17/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
10.0%
3/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
13.3%
4/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
10.0%
3/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
13.3%
4/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
10.0%
3/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
10.0%
3/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Vascular disorders
Hot flashes
|
26.7%
8/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Vascular disorders
Hypertension
|
30.0%
9/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Vascular disorders
Hypotension
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Vascular disorders
Lymphedema
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Vascular disorders
Lymphocele
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Vascular disorders
Thromboembolic event
|
3.3%
1/30
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60