Trial Outcomes & Findings for Bortezomib and Gemcitabine in Treating Patients With Relapsed B-Cell Non-Hodgkin Lymphoma (NCT NCT00863369)
NCT ID: NCT00863369
Last Updated: 2024-03-20
Results Overview
Adverse events were graded by NCI CTCAE, Version 3.0. DLT defined as grade 4 thrombocytopenia, or grade 3 thrombocytopenia lasting greater than 7 days. Grade 4 neutropenia lasting 7 days or more despite use of growth factors. Febrile neutropenia only is it occurs after 7 days of neutropenia. Any grade 3 or higher non-hematologic toxicity related to the study drug, with the exception of alopecia, inadequately treated nausea, vomiting and/or diarrhea and fatigue.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
33 participants
Primary outcome timeframe
28 days from start of treatment, up to 2 years.
Results posted on
2024-03-20
Participant Flow
Participant milestones
| Measure |
Dose Level 1 Tx Schema I - Velcade 1.0 mg/m2, Gemcitabine 1000 mg/m2
Patients receive 1.0 mg/m2 of velcade IV days 1, 4, 8, 11, and 1000 mg/m2 of gemcitabine hydrochloride IV over 3-4 hours. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
|
Dose Level Tx Schema I -1 - Velcade 1.0 mg/m2, Gemcitabine 800 mg/m2
Patients receive 1.0 mg/m2 of velcade IV days 1, 4, 8, 11, and 800 mg/m2 of gemcitabine hydrochloride IV over 3-4 hours. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
|
Dose Level 3B Tx Schema II - Velcade 1.0 mg/m2, Gemcitabine 800 mg/m2
Patients receive 1.0 mg/m2 of velcade IV days 1, 15, and 800 mg/m2 of gemcitabine hydrochloride IV over 3-4 hours. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
|
Dose Level 4B Tx Schema II - Velcade 1.3 mg/m2, Gemcitabine 800 mg/m2
Patients receive 1.3 mg/m2 of velcade IV days 1, 15, and 800 mg/m2 of gemcitabine hydrochloride IV over 3-4 hours. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
|
Dose Level 5B Tx Schema II - Velcade 1.3 mg/m2, Gemcitabine 1000 mg/m2
Patients receive 1.3 mg/m2 of velcade IV days 1, 15, and 1000 mg/m2 of gemcitabine hydrochloride IV over 3-4 hours. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
|
Dose Level 5B Tx Schema II - Velcade 1.3 mg/m2, Gemcitabine 1000 mg/m2, Rituximab 375 mg/m2
Patients receive 1.3 mg/m2 of velcade IV days 1, 15, and 800 mg/m2 of gemcitabine hydrochloride IV over 3-4 hours 375 mg/m2 of rituximab IV on days 1 and 15. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
5
|
4
|
3
|
6
|
11
|
|
Overall Study
COMPLETED
|
4
|
5
|
4
|
3
|
6
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bortezomib and Gemcitabine in Treating Patients With Relapsed B-Cell Non-Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
Dose Level 1 Tx Schema I - Velcade 1.0 mg/m2, Gemcitabine 1000 mg/m2
n=4 Participants
Patients receive 1.0 mg/m2 of velcade IV days 1, 4, 8, 11, and 1000 mg/m2 of gemcitabine hydrochloride IV over 3-4 hours. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
|
Dose Level Tx Schema I -1 - Velcade 1.0 mg/m2, Gemcitabine 800 mg/m2
n=5 Participants
Patients receive 1.0 mg/m2 of velcade IV days 1, 4, 8, 11, and 800 mg/m2 of gemcitabine hydrochloride IV over 3-4 hours. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
|
Dose Level 3B Tx Schema II - Velcade 1.0 mg/m2, Gemcitabine 800 mg/m2
n=4 Participants
Patients receive 1.0 mg/m2 of velcade IV days 1, 15, and 800 mg/m2 of gemcitabine hydrochloride IV over 3-4 hours. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
|
Dose Level 4B Tx Schema II - Velcade 1.3 mg/m2, Gemcitabine 800 mg/m2
n=3 Participants
Patients receive 1.3 mg/m2 of velcade IV days 1, 15, and 800 mg/m2 of gemcitabine hydrochloride IV over 3-4 hours. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
|
Dose Level 5B Tx Schema II - Velcade 1.3 mg/m2, Gemcitabine 1000 mg/m2
n=6 Participants
Patients receive 1.3 mg/m2 of velcade IV days 1, 15, and 1000 mg/m2 of gemcitabine hydrochloride IV over 3-4 hours. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
|
Dose Level 5B Tx Schema II - Velcade 1.3 mg/m2, Gemcitabine 1000 mg/m2, Rituximab 375 mg/m2
n=11 Participants
Patients receive 1.3 mg/m2 of velcade IV days 1, 15, and 800 mg/m2 of gemcitabine hydrochloride IV over 3-4 hours 375 mg/m2 of rituximab IV on days 1 and 15. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
60 years
n=5 Participants
|
50 years
n=7 Participants
|
58 years
n=5 Participants
|
66 years
n=4 Participants
|
72 years
n=21 Participants
|
66 years
n=10 Participants
|
65 years
n=115 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
23 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
White Non-Hispanic
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
22 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
4 participants
n=5 Participants
|
3 participants
n=4 Participants
|
6 participants
n=21 Participants
|
11 participants
n=10 Participants
|
33 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: 28 days from start of treatment, up to 2 years.Adverse events were graded by NCI CTCAE, Version 3.0. DLT defined as grade 4 thrombocytopenia, or grade 3 thrombocytopenia lasting greater than 7 days. Grade 4 neutropenia lasting 7 days or more despite use of growth factors. Febrile neutropenia only is it occurs after 7 days of neutropenia. Any grade 3 or higher non-hematologic toxicity related to the study drug, with the exception of alopecia, inadequately treated nausea, vomiting and/or diarrhea and fatigue.
Outcome measures
| Measure |
Dose Level 1 Tx Schema I - Velcade 1.0 mg/m2, Gemcitabine 1000 mg/m2
n=4 Participants
Patients receive 1.0 mg/m2 of velcade IV days 1, 4, 8, 11, and 1000 mg/m2 of gemcitabine hydrochloride IV over 3-4 hours. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
|
Dose Level Tx Schema I -1 - Velcade 1.0 mg/m2, Gemcitabine 800 mg/m2
n=5 Participants
Patients receive 1.0 mg/m2 of velcade IV days 1, 4, 8, 11, and 800 mg/m2 of gemcitabine hydrochloride IV over 3-4 hours. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
|
Dose Level 3B Tx Schema II - Velcade 1.0 mg/m2, Gemcitabine 800 mg/m2
n=4 Participants
Patients receive 1.0 mg/m2 of velcade IV days 1, 15, and 800 mg/m2 of gemcitabine hydrochloride IV over 3-4 hours. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
|
Dose Level 4B Tx Schema II - Velcade 1.3 mg/m2, Gemcitabine 800 mg/m2
n=3 Participants
Patients receive 1.3 mg/m2 of velcade IV days 1, 15, and 800 mg/m2 of gemcitabine hydrochloride IV over 3-4 hours. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
|
Dose Level 5B Tx Schema II - Velcade 1.3 mg/m2, Gemcitabine 1000 mg/m2
n=6 Participants
Patients receive 1.3 mg/m2 of velcade IV days 1, 15, and 1000 mg/m2 of gemcitabine hydrochloride IV over 3-4 hours. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
|
Dose Level 5B Tx Schema II - Velcade 1.3 mg/m2, Gemcitabine 1000 mg/m2, Rituximab 375 mg/m2
n=11 Participants
Patients receive 1.3 mg/m2 of velcade IV days 1, 15, and 800 mg/m2 of gemcitabine hydrochloride IV over 3-4 hours 375 mg/m2 of rituximab IV on days 1 and 15. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|---|
|
Number of Participants With at Least One Dose Limiting Toxicity (DLT)
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 28 days from start of treatment, up to 2 years.The maximum tolerated dose (MTD) of Gemcitabine in combination with 1.3 mg/m2 of velcade on days 1 and 15 is based on toxicities observed during the first cycle and is defined as the highest dose tested in which fewer than 33% of patients experience an attributable DLT to the study drug, when at least 6 patients are treated at that dose and are evaluable for toxicity. Dose escalations proceeded according to a standard 3+3 design.
Outcome measures
| Measure |
Dose Level 1 Tx Schema I - Velcade 1.0 mg/m2, Gemcitabine 1000 mg/m2
n=11 Participants
Patients receive 1.0 mg/m2 of velcade IV days 1, 4, 8, 11, and 1000 mg/m2 of gemcitabine hydrochloride IV over 3-4 hours. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
|
Dose Level Tx Schema I -1 - Velcade 1.0 mg/m2, Gemcitabine 800 mg/m2
Patients receive 1.0 mg/m2 of velcade IV days 1, 4, 8, 11, and 800 mg/m2 of gemcitabine hydrochloride IV over 3-4 hours. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
|
Dose Level 3B Tx Schema II - Velcade 1.0 mg/m2, Gemcitabine 800 mg/m2
Patients receive 1.0 mg/m2 of velcade IV days 1, 15, and 800 mg/m2 of gemcitabine hydrochloride IV over 3-4 hours. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
|
Dose Level 4B Tx Schema II - Velcade 1.3 mg/m2, Gemcitabine 800 mg/m2
Patients receive 1.3 mg/m2 of velcade IV days 1, 15, and 800 mg/m2 of gemcitabine hydrochloride IV over 3-4 hours. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
|
Dose Level 5B Tx Schema II - Velcade 1.3 mg/m2, Gemcitabine 1000 mg/m2
Patients receive 1.3 mg/m2 of velcade IV days 1, 15, and 1000 mg/m2 of gemcitabine hydrochloride IV over 3-4 hours. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
|
Dose Level 5B Tx Schema II - Velcade 1.3 mg/m2, Gemcitabine 1000 mg/m2, Rituximab 375 mg/m2
Patients receive 1.3 mg/m2 of velcade IV days 1, 15, and 800 mg/m2 of gemcitabine hydrochloride IV over 3-4 hours 375 mg/m2 of rituximab IV on days 1 and 15. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|---|
|
Recommended Phase II Dose
|
1000 mg/m^2
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 1 yearPer standard lymphoma response criteria (Cheson): Complete Response (CR), 1. Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related symptoms if present before therapy, with normalization of LDH if elevated prior to therapy. 2. All lymph nodes and masses must regress to normal size (\<1.5 cm in greatest transverse diameter if \>1.5 cm prior to treatment). 3. The spleen, if enlarged prior to therapy, must have regressed to normal size. 3. If bone marrow was involved by lymphoma, it must be cleared as documented by biopsy at the same location.
Outcome measures
| Measure |
Dose Level 1 Tx Schema I - Velcade 1.0 mg/m2, Gemcitabine 1000 mg/m2
n=4 Participants
Patients receive 1.0 mg/m2 of velcade IV days 1, 4, 8, 11, and 1000 mg/m2 of gemcitabine hydrochloride IV over 3-4 hours. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
|
Dose Level Tx Schema I -1 - Velcade 1.0 mg/m2, Gemcitabine 800 mg/m2
n=5 Participants
Patients receive 1.0 mg/m2 of velcade IV days 1, 4, 8, 11, and 800 mg/m2 of gemcitabine hydrochloride IV over 3-4 hours. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
|
Dose Level 3B Tx Schema II - Velcade 1.0 mg/m2, Gemcitabine 800 mg/m2
n=4 Participants
Patients receive 1.0 mg/m2 of velcade IV days 1, 15, and 800 mg/m2 of gemcitabine hydrochloride IV over 3-4 hours. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
|
Dose Level 4B Tx Schema II - Velcade 1.3 mg/m2, Gemcitabine 800 mg/m2
n=3 Participants
Patients receive 1.3 mg/m2 of velcade IV days 1, 15, and 800 mg/m2 of gemcitabine hydrochloride IV over 3-4 hours. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
|
Dose Level 5B Tx Schema II - Velcade 1.3 mg/m2, Gemcitabine 1000 mg/m2
n=6 Participants
Patients receive 1.3 mg/m2 of velcade IV days 1, 15, and 1000 mg/m2 of gemcitabine hydrochloride IV over 3-4 hours. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
|
Dose Level 5B Tx Schema II - Velcade 1.3 mg/m2, Gemcitabine 1000 mg/m2, Rituximab 375 mg/m2
n=11 Participants
Patients receive 1.3 mg/m2 of velcade IV days 1, 15, and 800 mg/m2 of gemcitabine hydrochloride IV over 3-4 hours 375 mg/m2 of rituximab IV on days 1 and 15. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|---|
|
Number of Subject With Complete Response
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
Adverse Events
Dose Level 1 Tx Schema I - Velcade 1.0 mg/m2, Gemcitabine 1000 mg/m2
Serious events: 3 serious events
Other events: 4 other events
Deaths: 3 deaths
Dose Level Tx Schema I -1 - Velcade 1.0 mg/m2, Gemcitabine 800 mg/m2
Serious events: 3 serious events
Other events: 5 other events
Deaths: 4 deaths
Dose Level 3B Tx Schema II - Velcade 1.0 mg/m2, Gemcitabine 800 mg/m2
Serious events: 3 serious events
Other events: 4 other events
Deaths: 4 deaths
Dose Level 4B Tx Schema II - Velcade 1.3 mg/m2, Gemcitabine 800 mg/m2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 3 deaths
Dose Level 5B Tx Schema II - Velcade 1.3 mg/m2, Gemcitabine 1000 mg/m2
Serious events: 0 serious events
Other events: 6 other events
Deaths: 4 deaths
Dose Level 5B Tx Schema II - Velcade 1.3 mg/m2, Gemcitabine 1000 mg/m2, Rituximab 375 mg/m2
Serious events: 4 serious events
Other events: 11 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
Dose Level 1 Tx Schema I - Velcade 1.0 mg/m2, Gemcitabine 1000 mg/m2
n=4 participants at risk
Patients receive 1.0 mg/m2 of velcade IV days 1, 4, 8, 11, and 1000 mg/m2 of gemcitabine hydrochloride IV over 3-4 hours. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
|
Dose Level Tx Schema I -1 - Velcade 1.0 mg/m2, Gemcitabine 800 mg/m2
n=5 participants at risk
Patients receive 1.0 mg/m2 of velcade IV days 1, 4, 8, 11, and 800 mg/m2 of gemcitabine hydrochloride IV over 3-4 hours. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
|
Dose Level 3B Tx Schema II - Velcade 1.0 mg/m2, Gemcitabine 800 mg/m2
n=4 participants at risk
Patients receive 1.0 mg/m2 of velcade IV days 1, 15, and 800 mg/m2 of gemcitabine hydrochloride IV over 3-4 hours. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
|
Dose Level 4B Tx Schema II - Velcade 1.3 mg/m2, Gemcitabine 800 mg/m2
n=3 participants at risk
Patients receive 1.3 mg/m2 of velcade IV days 1, 15, and 800 mg/m2 of gemcitabine hydrochloride IV over 3-4 hours. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
|
Dose Level 5B Tx Schema II - Velcade 1.3 mg/m2, Gemcitabine 1000 mg/m2
n=6 participants at risk
Patients receive 1.3 mg/m2 of velcade IV days 1, 15, and 1000 mg/m2 of gemcitabine hydrochloride IV over 3-4 hours. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
|
Dose Level 5B Tx Schema II - Velcade 1.3 mg/m2, Gemcitabine 1000 mg/m2, Rituximab 375 mg/m2
n=11 participants at risk
Patients receive 1.3 mg/m2 of velcade IV days 1, 15, and 800 mg/m2 of gemcitabine hydrochloride IV over 3-4 hours 375 mg/m2 of rituximab IV on days 1 and 15. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
25.0%
1/4 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/11 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
9.1%
1/11 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/11 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L)
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
20.0%
1/5 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
18.2%
2/11 • Number of events 2 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
18.2%
2/11 • Number of events 2 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Infection with unknown ANC
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
9.1%
1/11 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
20.0%
1/5 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/11 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Lymphopenia
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
20.0%
1/5 • Number of events 3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/11 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
50.0%
2/4 • Number of events 3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/11 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Platelets
|
75.0%
3/4 • Number of events 5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/11 • Adverse events occurred over a period of 3 years.
"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/pulmonary infiltrates
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/11 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (Specify, __)
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
9.1%
1/11 • Number of events 5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
9.1%
1/11 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
Other adverse events
| Measure |
Dose Level 1 Tx Schema I - Velcade 1.0 mg/m2, Gemcitabine 1000 mg/m2
n=4 participants at risk
Patients receive 1.0 mg/m2 of velcade IV days 1, 4, 8, 11, and 1000 mg/m2 of gemcitabine hydrochloride IV over 3-4 hours. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
|
Dose Level Tx Schema I -1 - Velcade 1.0 mg/m2, Gemcitabine 800 mg/m2
n=5 participants at risk
Patients receive 1.0 mg/m2 of velcade IV days 1, 4, 8, 11, and 800 mg/m2 of gemcitabine hydrochloride IV over 3-4 hours. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
|
Dose Level 3B Tx Schema II - Velcade 1.0 mg/m2, Gemcitabine 800 mg/m2
n=4 participants at risk
Patients receive 1.0 mg/m2 of velcade IV days 1, 15, and 800 mg/m2 of gemcitabine hydrochloride IV over 3-4 hours. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
|
Dose Level 4B Tx Schema II - Velcade 1.3 mg/m2, Gemcitabine 800 mg/m2
n=3 participants at risk
Patients receive 1.3 mg/m2 of velcade IV days 1, 15, and 800 mg/m2 of gemcitabine hydrochloride IV over 3-4 hours. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
|
Dose Level 5B Tx Schema II - Velcade 1.3 mg/m2, Gemcitabine 1000 mg/m2
n=6 participants at risk
Patients receive 1.3 mg/m2 of velcade IV days 1, 15, and 1000 mg/m2 of gemcitabine hydrochloride IV over 3-4 hours. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
|
Dose Level 5B Tx Schema II - Velcade 1.3 mg/m2, Gemcitabine 1000 mg/m2, Rituximab 375 mg/m2
n=11 participants at risk
Patients receive 1.3 mg/m2 of velcade IV days 1, 15, and 800 mg/m2 of gemcitabine hydrochloride IV over 3-4 hours 375 mg/m2 of rituximab IV on days 1 and 15. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Calcium, serum-high (hypercalcemia)
|
25.0%
1/4 • Number of events 2 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
20.0%
1/5 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
1/3 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/11 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
80.0%
4/5 • Number of events 4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
2/6 • Number of events 2 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
36.4%
4/11 • Number of events 15 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
1/3 • Number of events 2 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
50.0%
3/6 • Number of events 7 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
9.1%
1/11 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
25.0%
1/4 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
60.0%
3/5 • Number of events 4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
50.0%
2/4 • Number of events 6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
50.0%
3/6 • Number of events 6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
18.2%
2/11 • Number of events 3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow - Other (Specify, __)
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
20.0%
1/5 • Number of events 3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/11 • Adverse events occurred over a period of 3 years.
"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
|
75.0%
3/4 • Number of events 14 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
100.0%
5/5 • Number of events 15 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
75.0%
3/4 • Number of events 10 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
1/3 • Number of events 2 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
100.0%
6/6 • Number of events 26 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
90.9%
10/11 • Number of events 33 • Adverse events occurred over a period of 3 years.
"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 (e.g., immune hemolytic anemia, drug-related hemolysis)
|
25.0%
1/4 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/11 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Left ventricular diastolic dysfunction
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
2/6 • Number of events 3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/11 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia
|
25.0%
1/4 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
20.0%
1/5 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/11 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Ear and labyrinth disorders
Hearing: patients without baseline audiogram and not enrolled in a monitoring program
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
20.0%
1/5 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/11 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Ear and labyrinth disorders
Tinnitus
|
25.0%
1/4 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
9.1%
1/11 • Number of events 4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Keratitis (corneal inflammation/corneal ulceration)
|
25.0%
1/4 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/11 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Constipation
|
50.0%
2/4 • Number of events 5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
40.0%
2/5 • Number of events 2 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
50.0%
2/4 • Number of events 3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
50.0%
3/6 • Number of events 5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
18.2%
2/11 • Number of events 4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
75.0%
3/4 • Number of events 4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
20.0%
1/5 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
50.0%
2/4 • Number of events 2 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
1/3 • Number of events 2 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
2/6 • Number of events 5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
9.1%
1/11 • Number of events 2 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Distension/bloating, abdominal
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
20.0%
1/5 • Number of events 3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
18.2%
2/11 • Number of events 6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 2 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/11 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
20.0%
1/5 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/11 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
9.1%
1/11 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Hemorrhage, GI
|
25.0%
1/4 • Number of events 2 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/11 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
2/4 • Number of events 3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
40.0%
2/5 • Number of events 2 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 2 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
36.4%
4/11 • Number of events 8 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Obstruction, GI
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
9.1%
1/11 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
18.2%
2/11 • Number of events 3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Constitutional Symptoms - Other (Specify, __)
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
20.0%
1/5 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/11 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Death not associated with CTCAE term
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/11 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Edema:limb
|
25.0%
1/4 • Number of events 7 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
20.0%
1/5 • Number of events 3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
2/6 • Number of events 6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
9.1%
1/11 • Number of events 2 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
75.0%
3/4 • Number of events 7 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
100.0%
5/5 • Number of events 13 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
50.0%
2/4 • Number of events 8 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
1/3 • Number of events 2 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
2/6 • Number of events 2 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
54.5%
6/11 • Number of events 16 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
25.0%
1/4 • Number of events 2 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
40.0%
2/5 • Number of events 2 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
27.3%
3/11 • Number of events 3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Flu-like syndrome
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
2/6 • Number of events 2 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
9.1%
1/11 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Injection site reaction/extravasation changes
|
25.0%
1/4 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/11 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Pain - Other (Specify, __)
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
40.0%
2/5 • Number of events 4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/11 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Rigors/chills
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
40.0%
2/5 • Number of events 2 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
9.1%
1/11 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
40.0%
2/5 • Number of events 4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/11 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L)
|
25.0%
1/4 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
40.0%
2/5 • Number of events 3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
9.1%
1/11 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
18.2%
2/11 • Number of events 3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Viral hepatitis
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
20.0%
1/5 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/11 • Adverse events occurred over a period of 3 years.
"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 (in absence of Grade 3 or 4 thrombocytopenia)
|
25.0%
1/4 • Number of events 2 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
20.0%
1/5 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/11 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Injury, poisoning and procedural complications
Prolonged chest tube drainage or air leak after pulmonary resection
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/11 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Injury, poisoning and procedural complications
Wound complication, non-infectious
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
20.0%
1/5 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/11 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
AGC
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
20.0%
1/5 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/11 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
100.0%
4/4 • Number of events 10 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
100.0%
5/5 • Number of events 10 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
100.0%
4/4 • Number of events 13 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
66.7%
2/3 • Number of events 4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
2/6 • Number of events 5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
54.5%
6/11 • Number of events 9 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
50.0%
2/4 • Number of events 5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
100.0%
5/5 • Number of events 9 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
75.0%
3/4 • Number of events 9 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
66.7%
2/3 • Number of events 4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
54.5%
6/11 • Number of events 7 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Alkaline phosphatase
|
25.0%
1/4 • Number of events 2 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
40.0%
2/5 • Number of events 4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
75.0%
3/4 • Number of events 8 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
1/3 • Number of events 2 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
36.4%
4/11 • Number of events 5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
25.0%
1/4 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/11 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Cholesterol, serum-high (hypercholesteremia)
|
25.0%
1/4 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
1/3 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/11 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Coagulation - Other (Specify, __)
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
20.0%
1/5 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/11 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Creatinine
|
25.0%
1/4 • Number of events 2 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
40.0%
2/5 • Number of events 4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
75.0%
3/4 • Number of events 9 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 2 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
18.2%
2/11 • Number of events 3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
FEV(1)
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
9.1%
1/11 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Leukocytes (total WBC)
|
75.0%
3/4 • Number of events 13 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
100.0%
5/5 • Number of events 13 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
50.0%
2/4 • Number of events 2 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
66.7%
2/3 • Number of events 3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
66.7%
4/6 • Number of events 5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
81.8%
9/11 • Number of events 34 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Lymphopenia
|
75.0%
3/4 • Number of events 14 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
80.0%
4/5 • Number of events 12 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/11 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Metabolic/Laboratory - Other (Specify, __)
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
20.0%
1/5 • Number of events 3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/11 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
75.0%
3/4 • Number of events 8 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
100.0%
5/5 • Number of events 7 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
50.0%
2/4 • Number of events 2 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
66.7%
2/3 • Number of events 3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
50.0%
3/6 • Number of events 4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
72.7%
8/11 • Number of events 29 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Platelets
|
75.0%
3/4 • Number of events 12 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
100.0%
5/5 • Number of events 15 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
75.0%
3/4 • Number of events 5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
100.0%
3/3 • Number of events 7 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
66.7%
4/6 • Number of events 12 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
63.6%
7/11 • Number of events 27 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Vital capacity
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
9.1%
1/11 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Weight loss
|
25.0%
1/4 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
9.1%
1/11 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Acidosis (metabolic or respiratory)
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
9.1%
1/11 • Number of events 3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
50.0%
2/4 • Number of events 8 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
100.0%
5/5 • Number of events 12 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
50.0%
2/4 • Number of events 9 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
66.7%
2/3 • Number of events 3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
2/6 • Number of events 4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
45.5%
5/11 • Number of events 8 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Alkalosis (metabolic or respiratory)
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
50.0%
2/4 • Number of events 2 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
9.1%
1/11 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
50.0%
2/4 • Number of events 2 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
20.0%
1/5 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
1/3 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
2/6 • Number of events 2 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
27.3%
3/11 • Number of events 6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Magnesium, serum-high (hypermagnesemia)
|
50.0%
2/4 • Number of events 2 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
9.1%
1/11 • Number of events 4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
20.0%
1/5 • Number of events 2 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
1/3 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
50.0%
3/6 • Number of events 7 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
18.2%
2/11 • Number of events 2 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
25.0%
1/4 • Number of events 4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
50.0%
3/6 • Number of events 3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/11 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
50.0%
2/4 • Number of events 2 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
9.1%
1/11 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
50.0%
2/4 • Number of events 2 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
40.0%
2/5 • Number of events 3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
1/3 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
18.2%
2/11 • Number of events 4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
25.0%
1/4 • Number of events 2 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
50.0%
2/4 • Number of events 4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
66.7%
2/3 • Number of events 3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
2/6 • Number of events 3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
45.5%
5/11 • Number of events 8 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Triglyceride, serum-high (hypertriglyceridemia)
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
20.0%
1/5 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/11 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Uric acid, serum-high (hyperuricemia)
|
25.0%
1/4 • Number of events 3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
20.0%
1/5 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 2 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
18.2%
2/11 • Number of events 4 • Adverse events occurred over a period of 3 years.
"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, generalized or specific area (not due to neuropathy)
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
50.0%
3/6 • Number of events 6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
27.3%
3/11 • Number of events 6 • Adverse events occurred over a period of 3 years.
"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
|
50.0%
2/4 • Number of events 9 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
80.0%
4/5 • Number of events 8 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
75.0%
3/4 • Number of events 9 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
2/6 • Number of events 4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
81.8%
9/11 • Number of events 34 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Dizziness
|
25.0%
1/4 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/11 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Extrapyramidal/involuntary movement/restlessness
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
9.1%
1/11 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
20.0%
1/5 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
18.2%
2/11 • Number of events 3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Neurology - Other (Specify, __)
|
25.0%
1/4 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/11 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Neuropathy: motor
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/11 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Neuropathy: sensory
|
75.0%
3/4 • Number of events 11 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
60.0%
3/5 • Number of events 5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
50.0%
2/4 • Number of events 2 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
1/3 • Number of events 3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
2/6 • Number of events 9 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
45.5%
5/11 • Number of events 14 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Somnolence/depressed level of consciousness
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
9.1%
1/11 • Number of events 3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Taste alteration (dysgeusia)
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
9.1%
1/11 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Tremor
|
25.0%
1/4 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
20.0%
1/5 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/11 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
20.0%
1/5 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/11 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Insomnia
|
25.0%
1/4 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
40.0%
2/5 • Number of events 3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
18.2%
2/11 • Number of events 5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Mood alteration
|
25.0%
1/4 • Number of events 2 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
80.0%
4/5 • Number of events 10 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
18.2%
2/11 • Number of events 3 • Adverse events occurred over a period of 3 years.
"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%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
9.1%
1/11 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Renal/Genitourinary - Other (Specify, __)
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
20.0%
1/5 • Number of events 4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/11 • Adverse events occurred over a period of 3 years.
"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 (including sneezing, nasal stuffiness, postnasal drip)
|
25.0%
1/4 • Number of events 3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/11 • Adverse events occurred over a period of 3 years.
"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
|
25.0%
1/4 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
40.0%
2/5 • Number of events 2 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
2/6 • Number of events 5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
36.4%
4/11 • Number of events 6 • Adverse events occurred over a period of 3 years.
"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 (shortness of breath)
|
25.0%
1/4 • Number of events 3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
18.2%
2/11 • Number of events 4 • Adverse events occurred over a period of 3 years.
"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, pulmonary/upper respiratory
|
50.0%
2/4 • Number of events 3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/11 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs (hiccups, singultus)
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
20.0%
1/5 • Number of events 2 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/11 • Adverse events occurred over a period of 3 years.
"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%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
9.1%
1/11 • Number of events 4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis (radiographic changes)
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/11 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (Specify, __)
|
25.0%
1/4 • Number of events 7 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
20.0%
1/5 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/11 • Adverse events occurred over a period of 3 years.
"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 changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/11 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, __)
|
25.0%
1/4 • Number of events 3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
20.0%
1/5 • Number of events 2 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/11 • Adverse events occurred over a period of 3 years.
"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
|
25.0%
1/4 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/11 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
25.0%
1/4 • Number of events 3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/11 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Induration/fibrosis (skin and subcutaneous tissue)
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
20.0%
1/5 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/11 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
25.0%
1/4 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/11 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)
|
25.0%
1/4 • Number of events 4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
20.0%
1/5 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/11 • Adverse events occurred over a period of 3 years.
"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/itching
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
18.2%
2/11 • Number of events 2 • Adverse events occurred over a period of 3 years.
"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/desquamation
|
25.0%
1/4 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
40.0%
2/5 • Number of events 3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
50.0%
2/4 • Number of events 2 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
9.1%
1/11 • Number of events 1 • Adverse events occurred over a period of 3 years.
"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 breakdown/decubitus ulcer
|
25.0%
1/4 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/11 • Adverse events occurred over a period of 3 years.
"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 (diaphoresis)
|
50.0%
2/4 • Number of events 2 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
40.0%
2/5 • Number of events 2 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
18.2%
2/11 • Number of events 2 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Flushing
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
20.0%
1/5 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/11 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
40.0%
2/5 • Number of events 3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/11 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
20.0%
1/5 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
1/6 • Number of events 1 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
9.1%
1/11 • Number of events 2 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Phlebitis (including superficial thrombosis)
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
9.1%
1/11 • Number of events 2 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
1/4 • Number of events 2 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/11 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Vascular - Other (Specify, __)
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/5 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/4 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/3 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/6 • Adverse events occurred over a period of 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
9.1%
1/11 • Number of events 1 • Adverse events occurred over a period of 3 years.
"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