Trial Outcomes & Findings for Bortezomib and Rituximab in Treating Patients With Mantle Cell Lymphoma Who Have Previously Undergone Stem Cell Transplantation (NCT NCT01267812)
NCT ID: NCT01267812
Last Updated: 2023-07-27
Results Overview
Assessed by Kaplan-Meier survival analysis. 95% confidence intervals will be calculated using Greenwood's formula.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
23 participants
Primary outcome timeframe
Participants were followed up to 5 years after initial treatment and Kaplan-Meier survival analysis was used to generate the two-year disease-free survival estimate presented.
Results posted on
2023-07-27
Participant Flow
Participant milestones
| Measure |
Treatment (Bortezomib and Rituximab)
Doses of bortezomib given is 1.3 mg/m\^2 weekly x 4 weeks given every 3 month x 8 cycles. Doses of RITUXAN given is 375 mg/m\^2 give weekly x 4 weeks given every 6 month for 4 cycles.
bortezomib: Given SC or IV
rituximab: Given IV
laboratory biomarker analysis: Correlative studies
immunohistochemistry staining method: Correlative studies
RNA analysis: Correlative studies
gene expression analysis: Correlative studies
DNA analysis: Correlative studies
pharmacological study: Correlative studies
pharmacogenomic studies: Correlative studies
Questionnaire Administration
|
|---|---|
|
Overall Study
STARTED
|
23
|
|
Overall Study
COMPLETED
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bortezomib and Rituximab in Treating Patients With Mantle Cell Lymphoma Who Have Previously Undergone Stem Cell Transplantation
Baseline characteristics by cohort
| Measure |
Treatment (Bortezomib and Rituximab)
n=23 Participants
Doses of bortezomib given is 1.3 mg/m2 weekly x 4 weeks given every 3 month x 8 cycles. Doses of RITUXAN given is 375 mg/m2 give weekly x 4 weeks given every 6 month for 4 cycles.
bortezomib: Given SC or IV
rituximab: Given IV
laboratory biomarker analysis: Correlative studies
immunohistochemistry staining method: Correlative studies
RNA analysis: Correlative studies
gene expression analysis: Correlative studies
DNA analysis: Correlative studies
pharmacological study: Correlative studies
pharmacogenomic studies: Correlative studies
Questionnaire Administration
|
|---|---|
|
Age, Continuous
|
59 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Participants were followed up to 5 years after initial treatment and Kaplan-Meier survival analysis was used to generate the two-year disease-free survival estimate presented.Assessed by Kaplan-Meier survival analysis. 95% confidence intervals will be calculated using Greenwood's formula.
Outcome measures
| Measure |
Treatment (Bortezomib and Rituximab)
n=23 Participants
Doses of bortezomib given is 1.3 mg/m\^2 weekly x 4 weeks given every 3 month x 8 cycles. Doses of RITUXAN given is 375 mg/m\^2 give weekly x 4 weeks given every 6 month for 4 cycles.
bortezomib: Given SC or IV rituximab: Given IV
|
|---|---|
|
Two-year Disease-free Survival
|
90 percentage of participants
Interval 66.0 to 97.0
|
SECONDARY outcome
Timeframe: Participants were followed up to 5 years after initial treatment and Kaplan-Meier survival analysis was used to generate the two-year overall survival estimate presented.Assessed by Kaplan-Meier survival analysis. 95% confidence intervals will be calculated using Greenwood's formula.
Outcome measures
| Measure |
Treatment (Bortezomib and Rituximab)
n=23 Participants
Doses of bortezomib given is 1.3 mg/m\^2 weekly x 4 weeks given every 3 month x 8 cycles. Doses of RITUXAN given is 375 mg/m\^2 give weekly x 4 weeks given every 6 month for 4 cycles.
bortezomib: Given SC or IV rituximab: Given IV
|
|---|---|
|
Two-year Overall Survival
|
95 percentage of participants
Interval 68.0 to 99.0
|
SECONDARY outcome
Timeframe: Participants were followed up to 5 years after initial treatment.Observed toxicities will be summarized in terms of type, severity (graded by NCI CTCAE version 4.0) and attribution.
Outcome measures
| Measure |
Treatment (Bortezomib and Rituximab)
n=23 Participants
Doses of bortezomib given is 1.3 mg/m\^2 weekly x 4 weeks given every 3 month x 8 cycles. Doses of RITUXAN given is 375 mg/m\^2 give weekly x 4 weeks given every 6 month for 4 cycles.
bortezomib: Given SC or IV rituximab: Given IV
|
|---|---|
|
Grade 3 or 4 Toxicities of Bortezomib and Rituximab Treatment
Anemia
|
2 Participants
|
|
Grade 3 or 4 Toxicities of Bortezomib and Rituximab Treatment
Lung infection
|
2 Participants
|
|
Grade 3 or 4 Toxicities of Bortezomib and Rituximab Treatment
Skin infection
|
1 Participants
|
|
Grade 3 or 4 Toxicities of Bortezomib and Rituximab Treatment
Neutropenia
|
17 Participants
|
|
Grade 3 or 4 Toxicities of Bortezomib and Rituximab Treatment
Lymphopenia
|
8 Participants
|
|
Grade 3 or 4 Toxicities of Bortezomib and Rituximab Treatment
Pneumonia
|
2 Participants
|
|
Grade 3 or 4 Toxicities of Bortezomib and Rituximab Treatment
Wound infection
|
1 Participants
|
|
Grade 3 or 4 Toxicities of Bortezomib and Rituximab Treatment
Hypertension
|
1 Participants
|
|
Grade 3 or 4 Toxicities of Bortezomib and Rituximab Treatment
Thrombocytopenia
|
1 Participants
|
Adverse Events
Treatment (Bortezomib and Rituximab)
Serious events: 7 serious events
Other events: 23 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Treatment (Bortezomib and Rituximab)
n=23 participants at risk
Doses of bortezomib given is 1.3 mg/m\^2 weekly x 4 weeks given every 3 month x 8 cycles. Doses of RITUXAN given is 375 mg/m\^2 give weekly x 4 weeks given every 6 month for 4 cycles.
bortezomib: Given SC or IV rituximab: Given IV
|
|---|---|
|
Investigations
Neutrophil Count Decreased
|
4.3%
1/23 • Number of events 1 • Up to five years after initial treatment
|
|
Infections and infestations
Skin Infection
|
4.3%
1/23 • Number of events 1 • Up to five years after initial treatment
|
|
Infections and infestations
Wound Infection
|
4.3%
1/23 • Number of events 1 • Up to five years after initial treatment
|
|
Infections and infestations
Lung Infection
|
4.3%
1/23 • Number of events 1 • Up to five years after initial treatment
|
|
General disorders
Fever
|
8.7%
2/23 • Number of events 2 • Up to five years after initial treatment
|
|
Blood and lymphatic system disorders
Myelodysplastic Syndrome
|
4.3%
1/23 • Number of events 1 • Up to five years after initial treatment
|
|
Infections and infestations
Human Metapneumovirus Infection
|
4.3%
1/23 • Number of events 1 • Up to five years after initial treatment
|
|
Infections and infestations
Febrile Neutropenia
|
4.3%
1/23 • Number of events 1 • Up to five years after initial treatment
|
|
Infections and infestations
Meningitis
|
4.3%
1/23 • Number of events 1 • Up to five years after initial treatment
|
Other adverse events
| Measure |
Treatment (Bortezomib and Rituximab)
n=23 participants at risk
Doses of bortezomib given is 1.3 mg/m\^2 weekly x 4 weeks given every 3 month x 8 cycles. Doses of RITUXAN given is 375 mg/m\^2 give weekly x 4 weeks given every 6 month for 4 cycles.
bortezomib: Given SC or IV rituximab: Given IV
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
65.2%
15/23 • Number of events 46 • Up to five years after initial treatment
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
4.3%
1/23 • Number of events 1 • Up to five years after initial treatment
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.3%
1/23 • Number of events 1 • Up to five years after initial treatment
|
|
Cardiac disorders
Atrial fibrillation
|
4.3%
1/23 • Number of events 1 • Up to five years after initial treatment
|
|
Cardiac disorders
Sinus bradycardia
|
8.7%
2/23 • Number of events 2 • Up to five years after initial treatment
|
|
Cardiac disorders
Sinus tachycardia
|
4.3%
1/23 • Number of events 1 • Up to five years after initial treatment
|
|
Ear and labyrinth disorders
Hearing impaired
|
26.1%
6/23 • Number of events 7 • Up to five years after initial treatment
|
|
Ear and labyrinth disorders
Tinnitus
|
21.7%
5/23 • Number of events 6 • Up to five years after initial treatment
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
8.7%
2/23 • Number of events 2 • Up to five years after initial treatment
|
|
Eye disorders
Blurred vision
|
4.3%
1/23 • Number of events 1 • Up to five years after initial treatment
|
|
Eye disorders
Dry eye
|
4.3%
1/23 • Number of events 1 • Up to five years after initial treatment
|
|
Eye disorders
Eye disorders - Other, specify
|
13.0%
3/23 • Number of events 4 • Up to five years after initial treatment
|
|
Eye disorders
Watering eyes
|
8.7%
2/23 • Number of events 3 • Up to five years after initial treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
17.4%
4/23 • Number of events 4 • Up to five years after initial treatment
|
|
Gastrointestinal disorders
Bloating
|
13.0%
3/23 • Number of events 4 • Up to five years after initial treatment
|
|
Gastrointestinal disorders
Constipation
|
13.0%
3/23 • Number of events 4 • Up to five years after initial treatment
|
|
Gastrointestinal disorders
Diarrhea
|
47.8%
11/23 • Number of events 16 • Up to five years after initial treatment
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
4.3%
1/23 • Number of events 3 • Up to five years after initial treatment
|
|
Gastrointestinal disorders
Mucositis oral
|
4.3%
1/23 • Number of events 1 • Up to five years after initial treatment
|
|
Gastrointestinal disorders
Nausea
|
26.1%
6/23 • Number of events 9 • Up to five years after initial treatment
|
|
Gastrointestinal disorders
Vomiting
|
13.0%
3/23 • Number of events 4 • Up to five years after initial treatment
|
|
General disorders
Chills
|
34.8%
8/23 • Number of events 9 • Up to five years after initial treatment
|
|
General disorders
Edema limbs
|
17.4%
4/23 • Number of events 5 • Up to five years after initial treatment
|
|
General disorders
Fatigue
|
91.3%
21/23 • Number of events 38 • Up to five years after initial treatment
|
|
General disorders
Fever
|
39.1%
9/23 • Number of events 13 • Up to five years after initial treatment
|
|
General disorders
Flu like symptoms
|
8.7%
2/23 • Number of events 2 • Up to five years after initial treatment
|
|
General disorders
Gait disturbance
|
13.0%
3/23 • Number of events 5 • Up to five years after initial treatment
|
|
General disorders
Injection site reaction
|
34.8%
8/23 • Number of events 9 • Up to five years after initial treatment
|
|
General disorders
Non-cardiac chest pain
|
4.3%
1/23 • Number of events 1 • Up to five years after initial treatment
|
|
General disorders
Pain
|
21.7%
5/23 • Number of events 5 • Up to five years after initial treatment
|
|
Immune system disorders
Allergic reaction
|
4.3%
1/23 • Number of events 1 • Up to five years after initial treatment
|
|
Immune system disorders
Immune system disorders - Other, specify
|
8.7%
2/23 • Number of events 3 • Up to five years after initial treatment
|
|
Infections and infestations
Eye infection
|
4.3%
1/23 • Number of events 1 • Up to five years after initial treatment
|
|
Infections and infestations
Infections and infestations - Other, specify
|
4.3%
1/23 • Number of events 1 • Up to five years after initial treatment
|
|
Infections and infestations
Lung infection
|
13.0%
3/23 • Number of events 4 • Up to five years after initial treatment
|
|
Infections and infestations
Skin infection
|
13.0%
3/23 • Number of events 3 • Up to five years after initial treatment
|
|
Infections and infestations
Upper respiratory infection
|
30.4%
7/23 • Number of events 12 • Up to five years after initial treatment
|
|
Infections and infestations
Wound infection
|
4.3%
1/23 • Number of events 1 • Up to five years after initial treatment
|
|
Injury, poisoning and procedural complications
Bruising
|
4.3%
1/23 • Number of events 1 • Up to five years after initial treatment
|
|
Injury, poisoning and procedural complications
Fall
|
4.3%
1/23 • Number of events 1 • Up to five years after initial treatment
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
4.3%
1/23 • Number of events 1 • Up to five years after initial treatment
|
|
Investigations
Alanine aminotransferase increased
|
34.8%
8/23 • Number of events 23 • Up to five years after initial treatment
|
|
Investigations
Alkaline phosphatase increased
|
17.4%
4/23 • Number of events 5 • Up to five years after initial treatment
|
|
Investigations
Aspartate aminotransferase increased
|
39.1%
9/23 • Number of events 19 • Up to five years after initial treatment
|
|
Investigations
Blood bilirubin increased
|
4.3%
1/23 • Number of events 1 • Up to five years after initial treatment
|
|
Investigations
Cholesterol high
|
4.3%
1/23 • Number of events 1 • Up to five years after initial treatment
|
|
Investigations
Creatinine increased
|
26.1%
6/23 • Number of events 17 • Up to five years after initial treatment
|
|
Investigations
Investigations - Other, specify
|
21.7%
5/23 • Number of events 37 • Up to five years after initial treatment
|
|
Investigations
Lymphocyte count decreased
|
52.2%
12/23 • Number of events 84 • Up to five years after initial treatment
|
|
Investigations
Neutrophil count decreased
|
87.0%
20/23 • Number of events 67 • Up to five years after initial treatment
|
|
Investigations
Platelet count decreased
|
73.9%
17/23 • Number of events 59 • Up to five years after initial treatment
|
|
Investigations
Weight gain
|
8.7%
2/23 • Number of events 3 • Up to five years after initial treatment
|
|
Investigations
White blood cell decreased
|
87.0%
20/23 • Number of events 89 • Up to five years after initial treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
17.4%
4/23 • Number of events 4 • Up to five years after initial treatment
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
4.3%
1/23 • Number of events 2 • Up to five years after initial treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
21.7%
5/23 • Number of events 10 • Up to five years after initial treatment
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
17.4%
4/23 • Number of events 6 • Up to five years after initial treatment
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
8.7%
2/23 • Number of events 3 • Up to five years after initial treatment
|
|
Metabolism and nutrition disorders
Hypernatremia
|
17.4%
4/23 • Number of events 5 • Up to five years after initial treatment
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
4.3%
1/23 • Number of events 1 • Up to five years after initial treatment
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
8.7%
2/23 • Number of events 2 • Up to five years after initial treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
8.7%
2/23 • Number of events 2 • Up to five years after initial treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
26.1%
6/23 • Number of events 10 • Up to five years after initial treatment
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
13.0%
3/23 • Number of events 5 • Up to five years after initial treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
13.0%
3/23 • Number of events 4 • Up to five years after initial treatment
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
8.7%
2/23 • Number of events 2 • Up to five years after initial treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
26.1%
6/23 • Number of events 9 • Up to five years after initial treatment
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
21.7%
5/23 • Number of events 8 • Up to five years after initial treatment
|
|
Metabolism and nutrition disorders
Obesity
|
4.3%
1/23 • Number of events 2 • Up to five years after initial treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
39.1%
9/23 • Number of events 14 • Up to five years after initial treatment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
21.7%
5/23 • Number of events 6 • Up to five years after initial treatment
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
4.3%
1/23 • Number of events 1 • Up to five years after initial treatment
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
17.4%
4/23 • Number of events 4 • Up to five years after initial treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
4.3%
1/23 • Number of events 1 • Up to five years after initial treatment
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
21.7%
5/23 • Number of events 6 • Up to five years after initial treatment
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
17.4%
4/23 • Number of events 4 • Up to five years after initial treatment
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
13.0%
3/23 • Number of events 4 • Up to five years after initial treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
4.3%
1/23 • Number of events 1 • Up to five years after initial treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
8.7%
2/23 • Number of events 2 • Up to five years after initial treatment
|
|
Nervous system disorders
Dizziness
|
8.7%
2/23 • Number of events 2 • Up to five years after initial treatment
|
|
Nervous system disorders
Headache
|
13.0%
3/23 • Number of events 5 • Up to five years after initial treatment
|
|
Nervous system disorders
Paresthesia
|
26.1%
6/23 • Number of events 6 • Up to five years after initial treatment
|
|
Nervous system disorders
Peripheral motor neuropathy
|
4.3%
1/23 • Number of events 1 • Up to five years after initial treatment
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
56.5%
13/23 • Number of events 26 • Up to five years after initial treatment
|
|
Nervous system disorders
Vasovagal reaction
|
4.3%
1/23 • Number of events 1 • Up to five years after initial treatment
|
|
Psychiatric disorders
Agitation
|
4.3%
1/23 • Number of events 1 • Up to five years after initial treatment
|
|
Psychiatric disorders
Anxiety
|
21.7%
5/23 • Number of events 6 • Up to five years after initial treatment
|
|
Psychiatric disorders
Depression
|
8.7%
2/23 • Number of events 2 • Up to five years after initial treatment
|
|
Psychiatric disorders
Insomnia
|
4.3%
1/23 • Number of events 1 • Up to five years after initial treatment
|
|
Psychiatric disorders
Libido decreased
|
4.3%
1/23 • Number of events 1 • Up to five years after initial treatment
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
4.3%
1/23 • Number of events 1 • Up to five years after initial treatment
|
|
Renal and urinary disorders
Hematuria
|
4.3%
1/23 • Number of events 1 • Up to five years after initial treatment
|
|
Renal and urinary disorders
Proteinuria
|
4.3%
1/23 • Number of events 1 • Up to five years after initial treatment
|
|
Reproductive system and breast disorders
Breast pain
|
8.7%
2/23 • Number of events 2 • Up to five years after initial treatment
|
|
Reproductive system and breast disorders
Gynecomastia
|
4.3%
1/23 • Number of events 1 • Up to five years after initial treatment
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specify
|
4.3%
1/23 • Number of events 1 • Up to five years after initial treatment
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
4.3%
1/23 • Number of events 1 • Up to five years after initial treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
39.1%
9/23 • Number of events 19 • Up to five years after initial treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.7%
2/23 • Number of events 3 • Up to five years after initial treatment
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
30.4%
7/23 • Number of events 10 • Up to five years after initial treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.3%
1/23 • Number of events 1 • Up to five years after initial treatment
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
4.3%
1/23 • Number of events 1 • Up to five years after initial treatment
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
39.1%
9/23 • Number of events 10 • Up to five years after initial treatment
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
34.8%
8/23 • Number of events 11 • Up to five years after initial treatment
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
4.3%
1/23 • Number of events 1 • Up to five years after initial treatment
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.7%
2/23 • Number of events 2 • Up to five years after initial treatment
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
8.7%
2/23 • Number of events 2 • Up to five years after initial treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
13.0%
3/23 • Number of events 3 • Up to five years after initial treatment
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
4.3%
1/23 • Number of events 1 • Up to five years after initial treatment
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
17.4%
4/23 • Number of events 5 • Up to five years after initial treatment
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
21.7%
5/23 • Number of events 6 • Up to five years after initial treatment
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
4.3%
1/23 • Number of events 1 • Up to five years after initial treatment
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
8.7%
2/23 • Number of events 2 • Up to five years after initial treatment
|
|
Vascular disorders
Hot flashes
|
4.3%
1/23 • Number of events 1 • Up to five years after initial treatment
|
|
Vascular disorders
Hypertension
|
73.9%
17/23 • Number of events 43 • Up to five years after initial treatment
|
|
Vascular disorders
Hypotension
|
4.3%
1/23 • Number of events 1 • Up to five years after initial treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place