Trial Outcomes & Findings for Bortezomib, Thalidomide, and Dexamethasone After Melphalan and Stem Cell Transplant in Treating Patients With Stage I-III Multiple Myeloma (NCT NCT00792142)
NCT ID: NCT00792142
Last Updated: 2021-08-19
Results Overview
All grade 3 and above treatment-related adverse events (AEs) during bortezomib/dexamethasone treatment cycles.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
45 participants
Primary outcome timeframe
After 4 months of maintenance therapy
Results posted on
2021-08-19
Participant Flow
Participant milestones
| Measure |
Treatment (Stem Cell Transplant, Maintenance Treatment)
Patients receive high-dose melphalan IV 200mg/m\^2 over 30 minutes on days -2 and -1 and undergo autologous peripheral blood stem cell transplantation (Minimum dose of 2 X 10(6) CD34 + cells/kg ) on day 0. Patients receive filgrastim 5ug/kg IV or SQ beginning on day 5 and continuing until blood counts recover. Beginning 4 to 8 weeks after transplantation, patients receive maintenance therapy comprising 1.3 mg/m\^2 of bortezomib IV on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive 40mg of oral dexamethasone on days 1 to 4. Treatment with dexamethasone repeats every month for 12 months in the absence of disease progression or unacceptable toxicity. Beginning 2 weeks after completion of bortezomib, patients receive 50mg/day of oral thalidomide once daily until disease progression.
|
|---|---|
|
Overall Study
STARTED
|
45
|
|
Overall Study
COMPLETED
|
45
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bortezomib, Thalidomide, and Dexamethasone After Melphalan and Stem Cell Transplant in Treating Patients With Stage I-III Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Treatment (Stem Cell Transplant, Maintenance Treatment)
n=45 Participants
Patients receive high-dose melphalan IV 200mg/m\^2 over 30 minutes on days -2 and -1 and undergo autologous peripheral blood stem cell transplantation (Minimum dose of 2 X 10(6) CD34 + cells/kg ) on day 0. Patients receive filgrastim 5ug/kg IV or SQ beginning on day 5 and continuing until blood counts recover. Beginning 4 to 8 weeks after transplantation, patients receive maintenance therapy comprising 1.3 mg/m\^2 of bortezomib IV on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive 40mg of oral dexamethasone on days 1 to 4. Treatment with dexamethasone repeats every month for 12 months in the absence of disease progression or unacceptable toxicity. Beginning 2 weeks after completion of bortezomib, patients receive 50mg/day of oral thalidomide once daily until disease progression.
|
|---|---|
|
Age, Continuous
|
55 years
n=39 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
45 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: After 4 months of maintenance therapyPopulation: Five patients did not start the maintenance phase of the study because of neurotoxicity (n=3), thrombocytopenia (n=1), or withdrawal of consent (n=1).
All grade 3 and above treatment-related adverse events (AEs) during bortezomib/dexamethasone treatment cycles.
Outcome measures
| Measure |
Treatment (Stem Cell Transplant, Maintenance Treatment)
n=40 Participants
Patients receive high-dose melphalan IV 200mg/m\^2 over 30 minutes on days -2 and -1 and undergo autologous peripheral blood stem cell transplantation (Minimum dose of 2 X 10(6) CD34 + cells/kg ) on day 0. Patients receive filgrastim 5ug/kg IV or SQ beginning on day 5 and continuing until blood counts recover. Beginning 4 to 8 weeks after transplantation, patients receive maintenance therapy comprising 1.3 mg/m\^2 of bortezomib IV on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive 40mg of oral dexamethasone on days 1 to 4. Treatment with dexamethasone repeats every month for 12 months in the absence of disease progression or unacceptable toxicity. Beginning 2 weeks after completion of bortezomib, patients receive 50mg/day of oral thalidomide once daily until disease progression.
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|---|---|
|
Number of Participants With Adverse Events
Leukopenia
|
1 Participants
|
|
Number of Participants With Adverse Events
Lymphopenia
|
13 Participants
|
|
Number of Participants With Adverse Events
Neutropenia
|
2 Participants
|
|
Number of Participants With Adverse Events
Thrombocytopenia
|
1 Participants
|
|
Number of Participants With Adverse Events
Cataract
|
1 Participants
|
|
Number of Participants With Adverse Events
Fatigue
|
2 Participants
|
|
Number of Participants With Adverse Events
Upper respiratory infection
|
1 Participants
|
|
Number of Participants With Adverse Events
Anxiety
|
1 Participants
|
|
Number of Participants With Adverse Events
Pain in extremity
|
1 Participants
|
|
Number of Participants With Adverse Events
Sinus bradycardia
|
1 Participants
|
|
Number of Participants With Adverse Events
Hyperglycemia
|
4 Participants
|
|
Number of Participants With Adverse Events
Hypophosphatemia
|
3 Participants
|
PRIMARY outcome
Timeframe: From date of treatment initiation until death from any cause, assessed up to one year.One year overall survival estimated using the product-limit method of Kaplan and Meier. Defined as the percentage of patients alive at year one after starting treatment.
Outcome measures
| Measure |
Treatment (Stem Cell Transplant, Maintenance Treatment)
n=45 Participants
Patients receive high-dose melphalan IV 200mg/m\^2 over 30 minutes on days -2 and -1 and undergo autologous peripheral blood stem cell transplantation (Minimum dose of 2 X 10(6) CD34 + cells/kg ) on day 0. Patients receive filgrastim 5ug/kg IV or SQ beginning on day 5 and continuing until blood counts recover. Beginning 4 to 8 weeks after transplantation, patients receive maintenance therapy comprising 1.3 mg/m\^2 of bortezomib IV on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive 40mg of oral dexamethasone on days 1 to 4. Treatment with dexamethasone repeats every month for 12 months in the absence of disease progression or unacceptable toxicity. Beginning 2 weeks after completion of bortezomib, patients receive 50mg/day of oral thalidomide once daily until disease progression.
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|---|---|
|
One Year Overall Survival
|
95 percentage of participants
Interval 89.0 to 100.0
|
SECONDARY outcome
Timeframe: Post-Thalidomide at 1 year.Population: Five patients did not start the maintenance phase of the study because of neurotoxicity (n=3), thrombocytopenia (n=1), or withdrawal of consent (n=1).
Complete Response (CR): Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow. Very Good Partial Response (VGPR): Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \< 100mg per 24-h. Partial Response (PR): \> 50% reduction of serum M-protein and reduction in 24-h urinary M-protein by \> 90% or to \< 200mg per 24-h In addition to the above listed criteria, if present at baseline, a . 50% reduction in the size of soft tissue plasmacytomas is also required. Stable Disease (SD): Not meeting criteria for CR, VGPR, PR or progressive disease. Relapse: Any of the following: Reappearance of serum or urine M-protein by immunofixation or electrophoresis Development of \> 5% plasma cells in the bone marrow. Appearance of any other sign of progression (i.e., new plasmacytoma, lytic bone lesion)
Outcome measures
| Measure |
Treatment (Stem Cell Transplant, Maintenance Treatment)
n=40 Participants
Patients receive high-dose melphalan IV 200mg/m\^2 over 30 minutes on days -2 and -1 and undergo autologous peripheral blood stem cell transplantation (Minimum dose of 2 X 10(6) CD34 + cells/kg ) on day 0. Patients receive filgrastim 5ug/kg IV or SQ beginning on day 5 and continuing until blood counts recover. Beginning 4 to 8 weeks after transplantation, patients receive maintenance therapy comprising 1.3 mg/m\^2 of bortezomib IV on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive 40mg of oral dexamethasone on days 1 to 4. Treatment with dexamethasone repeats every month for 12 months in the absence of disease progression or unacceptable toxicity. Beginning 2 weeks after completion of bortezomib, patients receive 50mg/day of oral thalidomide once daily until disease progression.
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|---|---|
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Count of Response in Patients Started on Maintenance Therapy
CR
|
20 Participants
|
|
Count of Response in Patients Started on Maintenance Therapy
VPR
|
2 Participants
|
|
Count of Response in Patients Started on Maintenance Therapy
PR
|
3 Participants
|
|
Count of Response in Patients Started on Maintenance Therapy
Relapsed
|
6 Participants
|
|
Count of Response in Patients Started on Maintenance Therapy
Not Assessed
|
9 Participants
|
SECONDARY outcome
Timeframe: From start of treatment initiation until disease progression, relapse or death from any cause, assessed up to 1 year.PFS estimated using the product-limit method of Kaplan and Meier. Defined as the percentage of patients progression-free at year one after starting treatment. International Myeloma Working Group uniform response criteria for disease progression: Increase of \> 25% from baseline in Serum M-component and/or (the absolute increase must be \> 0.5 g/dl); Urine M-component and/or (the absolute increase must be \> 200 mg/24 h; Only in patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels. The absolute increase must be \>l0mg/dl. Bone marrow plasma cell percentage: the absolute % must be \> 10%C; Definite development of new bone lesions or soft tissue plasmacytomas. or definite increase in the size of existing bone lesions or soft tissue plasmacytomas Development of hypercalcemia (corrected serum calcium \>11.5 mg/dl or 2.65 mmol/l) that can be attributed solely to the plasma cell proliferative disorder.
Outcome measures
| Measure |
Treatment (Stem Cell Transplant, Maintenance Treatment)
n=45 Participants
Patients receive high-dose melphalan IV 200mg/m\^2 over 30 minutes on days -2 and -1 and undergo autologous peripheral blood stem cell transplantation (Minimum dose of 2 X 10(6) CD34 + cells/kg ) on day 0. Patients receive filgrastim 5ug/kg IV or SQ beginning on day 5 and continuing until blood counts recover. Beginning 4 to 8 weeks after transplantation, patients receive maintenance therapy comprising 1.3 mg/m\^2 of bortezomib IV on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive 40mg of oral dexamethasone on days 1 to 4. Treatment with dexamethasone repeats every month for 12 months in the absence of disease progression or unacceptable toxicity. Beginning 2 weeks after completion of bortezomib, patients receive 50mg/day of oral thalidomide once daily until disease progression.
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|---|---|
|
One Year Progression-free Survival (PFS)
|
88 percentage of participants
Interval 79.0 to 98.0
|
Adverse Events
Treatment (Stem Cell Transplant, Maintenance Treatment)
Serious events: 9 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Stem Cell Transplant, Maintenance Treatment)
n=45 participants at risk
Patients receive high-dose melphalan IV 200mg/m\^2 over 30 minutes on days -2 and -1 and undergo autologous peripheral blood stem cell transplantation (Minimum dose of 2 X 10(6) CD34 + cells/kg ) on day 0. Patients receive filgrastim 5ug/kg IV or SQ beginning on day 5 and continuing until blood counts recover. Beginning 4 to 8 weeks after transplantation, patients receive maintenance therapy comprising 1.3 mg/m\^2 of bortezomib IV on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive 40mg of oral dexamethasone on days 1 to 4. Treatment with dexamethasone repeats every month for 12 months in the absence of disease progression or unacceptable toxicity. Beginning 2 weeks after completion of bortezomib, patients receive 50mg/day of oral thalidomide once daily until disease progression.
|
|---|---|
|
Cardiac disorders
Myocardial ischemia
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Sinus bradycardia
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Disease progression
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Bronchitis
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Peripheral nerve infection
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Headache
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Vascular disorder
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
Other adverse events
| Measure |
Treatment (Stem Cell Transplant, Maintenance Treatment)
n=45 participants at risk
Patients receive high-dose melphalan IV 200mg/m\^2 over 30 minutes on days -2 and -1 and undergo autologous peripheral blood stem cell transplantation (Minimum dose of 2 X 10(6) CD34 + cells/kg ) on day 0. Patients receive filgrastim 5ug/kg IV or SQ beginning on day 5 and continuing until blood counts recover. Beginning 4 to 8 weeks after transplantation, patients receive maintenance therapy comprising 1.3 mg/m\^2 of bortezomib IV on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive 40mg of oral dexamethasone on days 1 to 4. Treatment with dexamethasone repeats every month for 12 months in the absence of disease progression or unacceptable toxicity. Beginning 2 weeks after completion of bortezomib, patients receive 50mg/day of oral thalidomide once daily until disease progression.
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
68.9%
31/45 • Number of events 143 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Blood and lymphatic system disorders
Hemolysis
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Blood and lymphatic system disorders
Lymphatic disorder
|
2.2%
1/45 • Number of events 2 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Palpitations
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Sinus bradycardia
|
6.7%
3/45 • Number of events 4 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Ear and labyrinth disorders
Ear disorder
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Ear and labyrinth disorders
Ear pain
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Ear and labyrinth disorders
External ear pain
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Ear and labyrinth disorders
Hearing loss
|
6.7%
3/45 • Number of events 10 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Ear and labyrinth disorders
Tinnitus
|
4.4%
2/45 • Number of events 2 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Cataract
|
2.2%
1/45 • Number of events 3 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Dry eye syndrome
|
2.2%
1/45 • Number of events 2 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Eye disorder
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Eye pain
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Vision blurred
|
6.7%
3/45 • Number of events 3 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Watering eyes
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.4%
2/45 • Number of events 2 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Constipation
|
11.1%
5/45 • Number of events 6 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
15.6%
7/45 • Number of events 8 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.7%
3/45 • Number of events 6 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Flatulence
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Gastritis
|
2.2%
1/45 • Number of events 2 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
4.4%
2/45 • Number of events 2 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Lip pain
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Nausea
|
13.3%
6/45 • Number of events 7 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Tooth disorder
|
2.2%
1/45 • Number of events 2 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Toothache
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Vomiting
|
13.3%
6/45 • Number of events 6 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Chest pain
|
4.4%
2/45 • Number of events 3 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Chills
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Disease progression
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Edema limbs
|
24.4%
11/45 • Number of events 12 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Fatigue
|
33.3%
15/45 • Number of events 29 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Fever
|
17.8%
8/45 • Number of events 9 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
General symptom
|
4.4%
2/45 • Number of events 2 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Injection site reaction
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Localized edema
|
6.7%
3/45 • Number of events 3 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Pain
|
6.7%
3/45 • Number of events 3 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Bladder infection
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Bone infection
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Bronchitis
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Eye infection
|
4.4%
2/45 • Number of events 4 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Gastric infection
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Infection
|
4.4%
2/45 • Number of events 2 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Mucosal infection
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Opportunistic infection
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Peripheral nerve infection
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Pharyngitis
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Pneumonia
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Sepsis
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Upper respiratory infection
|
24.4%
11/45 • Number of events 16 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Injury, poisoning and procedural complications
Bruising
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
15/45 • Number of events 32 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Alkaline phosphatase increased
|
17.8%
8/45 • Number of events 26 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
42.2%
19/45 • Number of events 38 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Bilirubin increased
|
8.9%
4/45 • Number of events 4 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Carbon monoxide diffusing capacity decreased
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Creatinine increased
|
31.1%
14/45 • Number of events 41 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
INR increased
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Leukocyte count decreased
|
57.8%
26/45 • Number of events 103 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Lymphocyte count decreased
|
48.9%
22/45 • Number of events 81 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Neutrophil count decreased
|
48.9%
22/45 • Number of events 64 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Platelet count decreased
|
44.4%
20/45 • Number of events 66 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Serum cholesterol increased
|
13.3%
6/45 • Number of events 12 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Weight gain
|
6.7%
3/45 • Number of events 8 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Weight loss
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Blood bicarbonate decreased
|
8.9%
4/45 • Number of events 5 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
37.8%
17/45 • Number of events 44 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Blood uric acid increased
|
8.9%
4/45 • Number of events 10 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Obesity
|
2.2%
1/45 • Number of events 2 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
51.1%
23/45 • Number of events 57 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
40.0%
18/45 • Number of events 36 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum calcium increased
|
13.3%
6/45 • Number of events 14 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
33.3%
15/45 • Number of events 27 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
6.7%
3/45 • Number of events 4 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum magnesium increased
|
6.7%
3/45 • Number of events 6 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
20.0%
9/45 • Number of events 16 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
26.7%
12/45 • Number of events 20 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
8.9%
4/45 • Number of events 5 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
28.9%
13/45 • Number of events 28 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum sodium increased
|
4.4%
2/45 • Number of events 2 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum triglycerides increased
|
17.8%
8/45 • Number of events 16 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
4.4%
2/45 • Number of events 2 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
26.7%
12/45 • Number of events 20 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
4.4%
2/45 • Number of events 2 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
4.4%
2/45 • Number of events 2 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint disorder
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
15.6%
7/45 • Number of events 16 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Kyphosis
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
6.7%
3/45 • Number of events 5 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
6.7%
3/45 • Number of events 3 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
13.3%
6/45 • Number of events 12 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.1%
5/45 • Number of events 9 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
24.4%
11/45 • Number of events 20 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Depressed level of consciousness
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Dizziness
|
17.8%
8/45 • Number of events 11 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Facial muscle weakness
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Headache
|
22.2%
10/45 • Number of events 13 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Neuralgia
|
2.2%
1/45 • Number of events 6 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Neurological disorder NOS
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Olfactory nerve disorder
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
73.3%
33/45 • Number of events 160 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Tremor
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Anxiety
|
15.6%
7/45 • Number of events 10 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Depression
|
4.4%
2/45 • Number of events 4 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Insomnia
|
26.7%
12/45 • Number of events 24 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Hemoglobin urine positive
|
4.4%
2/45 • Number of events 2 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Protein urine positive
|
8.9%
4/45 • Number of events 5 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Urinary frequency
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Reproductive system and breast disorders
Pelvic pain
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Reproductive system and breast disorders
Vaginal dryness
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Reproductive system and breast disorders
Vaginal inflammation
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
11.1%
5/45 • Number of events 6 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
26.7%
12/45 • Number of events 20 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.7%
3/45 • Number of events 4 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage nasal
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccough
|
2.2%
1/45 • Number of events 2 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
4.4%
2/45 • Number of events 2 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
13.3%
6/45 • Number of events 7 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.4%
2/45 • Number of events 3 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Fat atrophy
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.4%
2/45 • Number of events 2 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
28.9%
13/45 • Number of events 17 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Sweating
|
6.7%
3/45 • Number of events 5 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Flushing
|
6.7%
3/45 • Number of events 8 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Hematoma
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Hemorrhage
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Hot flashes
|
4.4%
2/45 • Number of events 2 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Hypertension
|
2.2%
1/45 • Number of events 2 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Hypotension
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Thrombosis
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over a period of 3 years and 11 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place