Trial Outcomes & Findings for Cyclophosphamide With or Without Celecoxib in Treating Patients With Recurrent or Persistent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer (NCT NCT00538031)
NCT ID: NCT00538031
Last Updated: 2023-04-21
Results Overview
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
52 participants
Primary outcome timeframe
Up to 3 years
Results posted on
2023-04-21
Participant Flow
Participant milestones
| Measure |
Arm I (Cyclophosphamide Alone)
Patients receive 50 mg oral cyclophosphamide once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
|
Arm II (Cyclophosphamide + Celecoxib)
Patients receive 50 mg oral cyclophosphamide once daily and 400 mg oral celecoxib twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
26
|
|
Overall Study
COMPLETED
|
26
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cyclophosphamide With or Without Celecoxib in Treating Patients With Recurrent or Persistent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
Baseline characteristics by cohort
| Measure |
Arm I (Cyclophosphamide Alone)
n=26 Participants
Patients receive 50 mg oral cyclophosphamide once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
|
Arm II (Cyclophosphamide + Celecoxib)
n=26 Participants
Patients receive 50 mg oral cyclophosphamide once daily and 400 mg oral celecoxib twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60 years
n=99 Participants
|
61 years
n=107 Participants
|
61 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White non-Hispanic
|
20 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Native American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=99 Participants
|
26 participants
n=107 Participants
|
52 participants
n=206 Participants
|
|
Karnofsky performance status
|
90 units on a scale
n=99 Participants
|
90 units on a scale
n=107 Participants
|
90 units on a scale
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to 3 yearsPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Outcome measures
| Measure |
Arm I (Cyclophosphamide Alone)
n=26 Participants
Patients receive 50 mg oral cyclophosphamide once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
|
Arm II (Cyclophosphamide + Celecoxib)
n=26 Participants
Patients receive 50 mg oral cyclophosphamide once daily and 400 mg oral celecoxib twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Response
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 3 yearsEstimated using the product-limit method of Kaplan and Meier. Time to treatment failure is defined as the time from initial treatment to discontinuation of treatment for any reason, including progression of disease, treatment toxicity, and death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Arm I (Cyclophosphamide Alone)
n=26 Participants
Patients receive 50 mg oral cyclophosphamide once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
|
Arm II (Cyclophosphamide + Celecoxib)
n=26 Participants
Patients receive 50 mg oral cyclophosphamide once daily and 400 mg oral celecoxib twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Time to Treatment Failure
|
1.84 Months
Interval 1.68 to 2.76
|
1.92 Months
Interval 1.64 to 5.22
|
PRIMARY outcome
Timeframe: Up to 5 yearsEstimated using the product-limit method of Kaplan and Meier. From time of initial treatment to death from any cause.
Outcome measures
| Measure |
Arm I (Cyclophosphamide Alone)
n=26 Participants
Patients receive 50 mg oral cyclophosphamide once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
|
Arm II (Cyclophosphamide + Celecoxib)
n=26 Participants
Patients receive 50 mg oral cyclophosphamide once daily and 400 mg oral celecoxib twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Survival
|
9.69 Months
Interval 3.84 to 13.18
|
12.55 Months
Interval 6.67 to 17.61
|
Adverse Events
Arm I (Cyclophosphamide Alone)
Serious events: 4 serious events
Other events: 26 other events
Deaths: 26 deaths
Arm II (Cyclophosphamide + Celecoxib)
Serious events: 8 serious events
Other events: 26 other events
Deaths: 26 deaths
Serious adverse events
| Measure |
Arm I (Cyclophosphamide Alone)
n=26 participants at risk
Patients receive 50 mg oral cyclophosphamide once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
|
Arm II (Cyclophosphamide + Celecoxib)
n=26 participants at risk
Patients receive 50 mg oral cyclophosphamide once daily and 400 mg oral celecoxib twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.7%
2/26 • Number of events 2 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Nausea
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Vomiting
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Disease progression
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.7%
2/26 • Number of events 2 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
General symptom
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Catheter related infection
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Sepsis
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 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
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 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
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 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
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 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
|
7.7%
2/26 • Number of events 2 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
11.5%
3/26 • Number of events 3 • Adverse events occurred over a period of 7 years and 3 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
Hypoxia
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 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
Pneumonitis
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 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
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 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
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
Other adverse events
| Measure |
Arm I (Cyclophosphamide Alone)
n=26 participants at risk
Patients receive 50 mg oral cyclophosphamide once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
|
Arm II (Cyclophosphamide + Celecoxib)
n=26 participants at risk
Patients receive 50 mg oral cyclophosphamide once daily and 400 mg oral celecoxib twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Investigations
Leukopenia
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.7%
2/26 • Number of events 2 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Lymphocyte count decreased
|
11.5%
3/26 • Number of events 5 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
19.2%
5/26 • Number of events 6 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
3.8%
1/26 • Number of events 3 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
7.7%
2/26 • Number of events 2 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
11.5%
3/26 • Number of events 3 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.7%
2/26 • Number of events 2 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Lymphopenia
|
15.4%
4/26 • Number of events 5 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
11.5%
3/26 • Number of events 10 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Neutrophil count decreased
|
11.5%
3/26 • Number of events 3 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
11.5%
3/26 • Number of events 6 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Platelet count decreased
|
7.7%
2/26 • Number of events 4 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.7%
2/26 • Number of events 2 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Weight gain
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Weight loss
|
7.7%
2/26 • Number of events 2 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.7%
2/26 • Number of events 2 • Adverse events occurred over a period of 7 years and 3 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
|
30.8%
8/26 • Number of events 9 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
34.6%
9/26 • Number of events 14 • Adverse events occurred over a period of 7 years and 3 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
|
3.8%
1/26 • Number of events 3 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
11.5%
3/26 • Number of events 5 • Adverse events occurred over a period of 7 years and 3 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
|
23.1%
6/26 • Number of events 16 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
15.4%
4/26 • Number of events 5 • Adverse events occurred over a period of 7 years and 3 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
|
7.7%
2/26 • Number of events 2 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.7%
2/26 • Number of events 3 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
15.4%
4/26 • Number of events 4 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
3.8%
1/26 • Number of events 2 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
11.5%
3/26 • Number of events 5 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
19.2%
5/26 • Number of events 10 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
7.7%
2/26 • Number of events 2 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.7%
2/26 • Number of events 4 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
11.5%
3/26 • Number of events 3 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
11.5%
3/26 • Number of events 7 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Dyspareunia
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 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
Haemorrhage NOS
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 2 • Adverse events occurred over a period of 7 years and 3 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
Hemoglobin decreased
|
50.0%
13/26 • Number of events 32 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
65.4%
17/26 • Number of events 41 • Adverse events occurred over a period of 7 years and 3 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
Lymphangiopathy NOS
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 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
|
3.8%
1/26 • Number of events 4 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
11.5%
3/26 • Number of events 9 • Adverse events occurred over a period of 7 years and 3 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
Transfusion: pRBCs
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 3 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
7.7%
2/26 • Number of events 2 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
15.4%
4/26 • Number of events 4 • Adverse events occurred over a period of 7 years and 3 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
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Vision blurred
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 2 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
57.7%
15/26 • Number of events 22 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
57.7%
15/26 • Number of events 36 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 3 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Constipation
|
26.9%
7/26 • Number of events 11 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
38.5%
10/26 • Number of events 16 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
42.3%
11/26 • Number of events 17 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
42.3%
11/26 • Number of events 21 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
11.5%
3/26 • Number of events 3 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.7%
2/26 • Number of events 2 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
15.4%
4/26 • Number of events 4 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
19.2%
5/26 • Number of events 8 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Esophagitis
|
7.7%
2/26 • Number of events 2 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Fecal incontinence
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
11.5%
3/26 • Number of events 4 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Gastritis
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
7.7%
2/26 • Number of events 2 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
15.4%
4/26 • Number of events 6 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Incontinence
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Mucositis oral
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.7%
2/26 • Number of events 2 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
13/26 • Number of events 21 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
53.8%
14/26 • Number of events 26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Salivary gland disorder
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Stomach pain
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Vomiting
|
23.1%
6/26 • Number of events 9 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
38.5%
10/26 • Number of events 13 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Chest pain
|
15.4%
4/26 • Number of events 5 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.7%
2/26 • Number of events 2 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Chills
|
7.7%
2/26 • Number of events 2 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
15.4%
4/26 • Number of events 4 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Edema
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.7%
2/26 • Number of events 3 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Edema limbs
|
11.5%
3/26 • Number of events 4 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
11.5%
3/26 • Number of events 4 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Fatigue
|
50.0%
13/26 • Number of events 27 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
61.5%
16/26 • Number of events 39 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Fever
|
7.7%
2/26 • Number of events 2 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
15.4%
4/26 • Number of events 5 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
General symptom
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Localized edema
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Oedema NOS
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.7%
2/26 • Number of events 4 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Pain
|
38.5%
10/26 • Number of events 14 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
50.0%
13/26 • Number of events 46 • Adverse events occurred over a period of 7 years and 3 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
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Bronchitis
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Infection
|
7.7%
2/26 • Number of events 2 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Infection without neutropenia
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Skin infection
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 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
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Wound infection
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 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
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 2 • Adverse events occurred over a period of 7 years and 3 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
Vascular access complication
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
7.7%
2/26 • Number of events 6 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Alanine aminotransferase increased
|
26.9%
7/26 • Number of events 9 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
34.6%
9/26 • Number of events 14 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Alkaline phosphatase increased
|
57.7%
15/26 • Number of events 31 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
34.6%
9/26 • Number of events 14 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
73.1%
19/26 • Number of events 34 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
65.4%
17/26 • Number of events 40 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Bilirubin increased
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Creatinine increased
|
7.7%
2/26 • Number of events 4 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
19.2%
5/26 • Number of events 15 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Leukocyte count decreased
|
30.8%
8/26 • Number of events 22 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
23.1%
6/26 • Number of events 11 • Adverse events occurred over a period of 7 years and 3 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
|
26.9%
7/26 • Number of events 9 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
23.1%
6/26 • Number of events 13 • Adverse events occurred over a period of 7 years and 3 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
|
11.5%
3/26 • Number of events 3 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.7%
2/26 • Number of events 4 • Adverse events occurred over a period of 7 years and 3 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
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 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
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.7%
2/26 • Number of events 2 • Adverse events occurred over a period of 7 years and 3 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
|
7.7%
2/26 • Number of events 4 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
30.8%
8/26 • Number of events 17 • Adverse events occurred over a period of 7 years and 3 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
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 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
|
11.5%
3/26 • Number of events 3 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.7%
2/26 • Number of events 2 • Adverse events occurred over a period of 7 years and 3 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
|
11.5%
3/26 • Number of events 4 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
11.5%
3/26 • Number of events 3 • Adverse events occurred over a period of 7 years and 3 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
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 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
|
30.8%
8/26 • Number of events 12 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
23.1%
6/26 • Number of events 8 • Adverse events occurred over a period of 7 years and 3 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
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 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
|
7.7%
2/26 • Number of events 2 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
11.5%
3/26 • Number of events 3 • Adverse events occurred over a period of 7 years and 3 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
|
7.7%
2/26 • Number of events 2 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.7%
2/26 • Number of events 4 • Adverse events occurred over a period of 7 years and 3 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
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 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
|
11.5%
3/26 • Number of events 4 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 6 • Adverse events occurred over a period of 7 years and 3 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
|
7.7%
2/26 • Number of events 2 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
11.5%
3/26 • Number of events 3 • Adverse events occurred over a period of 7 years and 3 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
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.7%
2/26 • Number of events 3 • Adverse events occurred over a period of 7 years and 3 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
|
19.2%
5/26 • Number of events 9 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
11.5%
3/26 • Number of events 5 • Adverse events occurred over a period of 7 years and 3 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
Neck pain
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 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
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 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
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.7%
2/26 • Number of events 2 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Dizziness
|
11.5%
3/26 • Number of events 3 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
15.4%
4/26 • Number of events 11 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Extrapyramidal disorder
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 2 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Headache
|
26.9%
7/26 • Number of events 8 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
11.5%
3/26 • Number of events 6 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Memory impairment
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 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
|
3.8%
1/26 • Number of events 2 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.7%
2/26 • Number of events 2 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
7.7%
2/26 • Number of events 2 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 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
|
23.1%
6/26 • Number of events 9 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
23.1%
6/26 • Number of events 10 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Speech disorder
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Taste alteration
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Anxiety
|
23.1%
6/26 • Number of events 11 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
30.8%
8/26 • Number of events 10 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Depression
|
19.2%
5/26 • Number of events 7 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.7%
2/26 • Number of events 7 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Insomnia
|
15.4%
4/26 • Number of events 4 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Psychosis
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Bladder pain
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.7%
2/26 • Number of events 2 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Blood urine present
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Hematuria (in the absence of vaginal bleeding)
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Hemoglobinuria
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 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
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.7%
2/26 • Number of events 2 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.7%
2/26 • Number of events 2 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 3 • Adverse events occurred over a period of 7 years and 3 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
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
11.5%
3/26 • Number of events 5 • Adverse events occurred over a period of 7 years and 3 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 incontinence
|
3.8%
1/26 • Number of events 2 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 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 retention
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Urine discoloration
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Urogenital disorder
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.7%
2/26 • Number of events 2 • Adverse events occurred over a period of 7 years and 3 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
|
7.7%
2/26 • Number of events 6 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
19.2%
5/26 • Number of events 10 • Adverse events occurred over a period of 7 years and 3 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 hemorrhage
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
11.5%
3/26 • Number of events 11 • Adverse events occurred over a period of 7 years and 3 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
Adult respiratory distress syndrome
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 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
|
23.1%
6/26 • Number of events 8 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
19.2%
5/26 • Number of events 7 • Adverse events occurred over a period of 7 years and 3 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
|
19.2%
5/26 • Number of events 6 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
34.6%
9/26 • Number of events 11 • Adverse events occurred over a period of 7 years and 3 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
Hypoxia
|
11.5%
3/26 • Number of events 4 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 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
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 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
|
7.7%
2/26 • Number of events 2 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 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
Pleural effusion
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 2 • Adverse events occurred over a period of 7 years and 3 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
Pleuritic pain
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 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
Pneumonitis
|
3.8%
1/26 • Number of events 2 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 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
|
7.7%
2/26 • Number of events 2 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
11.5%
3/26 • Number of events 3 • Adverse events occurred over a period of 7 years and 3 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
Voice alteration
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 2 • Adverse events occurred over a period of 7 years and 3 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
Alopecia
|
7.7%
2/26 • Number of events 2 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.7%
2/26 • Number of events 4 • Adverse events occurred over a period of 7 years and 3 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
Decubitus ulcer
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 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
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
7.7%
2/26 • Number of events 5 • Adverse events occurred over a period of 7 years and 3 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
|
7.7%
2/26 • Number of events 2 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
11.5%
3/26 • Number of events 5 • Adverse events occurred over a period of 7 years and 3 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
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
11.5%
3/26 • Number of events 4 • Adverse events occurred over a period of 7 years and 3 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
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Hot flashes
|
3.8%
1/26 • Number of events 2 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/26 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Hypertension
|
3.8%
1/26 • Number of events 3 • Adverse events occurred over a period of 7 years and 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
3.8%
1/26 • Number of events 1 • Adverse events occurred over a period of 7 years and 3 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