Trial Outcomes & Findings for Stem Cell Transplant With or Without Tbo-filgrastim in Treating Patients With Multiple Myeloma or Non-Hodgkin Lymphoma (NCT NCT03317899)
NCT ID: NCT03317899
Last Updated: 2025-12-17
Results Overview
Will compare days to discharge readiness between the two groups.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
77 participants
Primary outcome timeframe
Up to 60 days
Results posted on
2025-12-17
Participant Flow
Participant milestones
| Measure |
Group I (auto HSCT tbo-filgrastim)
Beginning on day 3 after auto Hematopoietic Cell Transplantation (HSCT), patients receive tbo-filgrastim SC daily for 12-14 days.
Hematopoietic Cell Transplantation: Undergo auto HSCT
Tbo-filgrastim: Given subcutaneously
Laboratory Biomarker Analysis: Correlative Studies
|
Group II (auto HSCT)
Patients undergo auto Hematopoietic Cell Transplantation (HSCT).
Hematopoietic Cell Transplantation: Undergo auto HSCT
Laboratory Biomarker Analysis: Correlative Studies
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
39
|
|
Overall Study
COMPLETED
|
32
|
30
|
|
Overall Study
NOT COMPLETED
|
6
|
9
|
Reasons for withdrawal
| Measure |
Group I (auto HSCT tbo-filgrastim)
Beginning on day 3 after auto Hematopoietic Cell Transplantation (HSCT), patients receive tbo-filgrastim SC daily for 12-14 days.
Hematopoietic Cell Transplantation: Undergo auto HSCT
Tbo-filgrastim: Given subcutaneously
Laboratory Biomarker Analysis: Correlative Studies
|
Group II (auto HSCT)
Patients undergo auto Hematopoietic Cell Transplantation (HSCT).
Hematopoietic Cell Transplantation: Undergo auto HSCT
Laboratory Biomarker Analysis: Correlative Studies
|
|---|---|---|
|
Overall Study
Death
|
6
|
9
|
Baseline Characteristics
Stem Cell Transplant With or Without Tbo-filgrastim in Treating Patients With Multiple Myeloma or Non-Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
Group I (Auto HSCT Tbo-filgrastim)
n=38 Participants
Beginning on day 3 after auto Hematopoietic Cell Transplantation (HSCT), patients receive tbo-filgrastim SC daily for 12-14 days.
Hematopoietic Cell Transplantation: Undergo auto HSCT
Tbo-filgrastim: Given subcutaneously
Laboratory Biomarker Analysis: Correlative Studies
|
Group II (Auto HSCT)
n=39 Participants
Patients undergo auto Hematopoietic Cell Transplantation (HSCT).
Hematopoietic Cell Transplantation: Undergo auto HSCT
Laboratory Biomarker Analysis: Correlative Studies
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=6 Participants
|
20 Participants
n=5 Participants
|
49 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=6 Participants
|
19 Participants
n=5 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=6 Participants
|
20 Participants
n=5 Participants
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=6 Participants
|
19 Participants
n=5 Participants
|
45 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=6 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=6 Participants
|
37 Participants
n=5 Participants
|
70 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=6 Participants
|
9 Participants
n=5 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=6 Participants
|
27 Participants
n=5 Participants
|
51 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=6 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 60 daysWill compare days to discharge readiness between the two groups.
Outcome measures
| Measure |
Group I (auto HSCT tbo-filgrastim)
n=38 Participants
Beginning on day 3 after auto Hematopoietic Cell Transplantation (HSCT), patients receive tbo-filgrastim SC daily for 12-14 days.
Hematopoietic Cell Transplantation: Undergo auto HSCT
Tbo-filgrastim: Given subcutaneously
Laboratory Biomarker Analysis: Correlative Studies
|
Group II (auto HSCT)
n=39 Participants
Patients undergo auto Hematopoietic Cell Transplantation (HSCT).
Hematopoietic Cell Transplantation: Undergo auto HSCT
Laboratory Biomarker Analysis: Correlative Studies
|
|---|---|---|
|
Number of Days to Discharge
|
11 days
Interval 8.0 to 26.0
|
15 days
Interval 11.0 to 29.0
|
SECONDARY outcome
Timeframe: Up to 60 daysWill be defined as absolute neutrophil count \> 500 x 10\^9/L x 3 days. Day of engraftment is the first of the 3 days of absolute neutrophil count \> 500 x 10\^9/L.
Outcome measures
| Measure |
Group I (auto HSCT tbo-filgrastim)
n=38 Participants
Beginning on day 3 after auto Hematopoietic Cell Transplantation (HSCT), patients receive tbo-filgrastim SC daily for 12-14 days.
Hematopoietic Cell Transplantation: Undergo auto HSCT
Tbo-filgrastim: Given subcutaneously
Laboratory Biomarker Analysis: Correlative Studies
|
Group II (auto HSCT)
n=39 Participants
Patients undergo auto Hematopoietic Cell Transplantation (HSCT).
Hematopoietic Cell Transplantation: Undergo auto HSCT
Laboratory Biomarker Analysis: Correlative Studies
|
|---|---|---|
|
Median Days Post Autologous Hematopoietic Cell Transplantation (Auto HSCT) to Neutrophil Engraftment
|
11 days
Interval 8.0 to 13.0
|
13 days
Interval 11.0 to 16.0
|
SECONDARY outcome
Timeframe: Up to 60 daysWill be defined as date platelet greater than or equal to 20 x 10\^9 /L without a platelet transfusion within the last 7 days.
Outcome measures
| Measure |
Group I (auto HSCT tbo-filgrastim)
n=38 Participants
Beginning on day 3 after auto Hematopoietic Cell Transplantation (HSCT), patients receive tbo-filgrastim SC daily for 12-14 days.
Hematopoietic Cell Transplantation: Undergo auto HSCT
Tbo-filgrastim: Given subcutaneously
Laboratory Biomarker Analysis: Correlative Studies
|
Group II (auto HSCT)
n=39 Participants
Patients undergo auto Hematopoietic Cell Transplantation (HSCT).
Hematopoietic Cell Transplantation: Undergo auto HSCT
Laboratory Biomarker Analysis: Correlative Studies
|
|---|---|---|
|
Median Days Post Auto HSCT to Platelet Engraftment
|
19 days
Interval 16.0 to 25.0
|
19 days
Interval 16.0 to 27.0
|
SECONDARY outcome
Timeframe: Up to 60 daysWill be defined by the Maiolino Criteria. Will be summarized by treatment arm and compared using a chi-square test
Outcome measures
| Measure |
Group I (auto HSCT tbo-filgrastim)
n=38 Participants
Beginning on day 3 after auto Hematopoietic Cell Transplantation (HSCT), patients receive tbo-filgrastim SC daily for 12-14 days.
Hematopoietic Cell Transplantation: Undergo auto HSCT
Tbo-filgrastim: Given subcutaneously
Laboratory Biomarker Analysis: Correlative Studies
|
Group II (auto HSCT)
n=39 Participants
Patients undergo auto Hematopoietic Cell Transplantation (HSCT).
Hematopoietic Cell Transplantation: Undergo auto HSCT
Laboratory Biomarker Analysis: Correlative Studies
|
|---|---|---|
|
Percentage of Participants With Engraftment Syndrome
|
48.6 percentage of participants
|
60 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 60 daysPopulation: This data set was not reported. Upon further inspection into the subject data, there were few infections and most of the fevers were from neutropenia. No qualifying infections or fevers were reported to fit this specific criteria. Therefore, the numbers are presented as zero for both arms. Specific adverse event reporting data can be found in more detail in the AE/SAE section of this record.
Will be summarized by treatment arm and compared using Wilcoxon rank sum tests
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 60 daysWill be summarized by treatment arm and compared using Wilcoxon rank sum tests.
Outcome measures
| Measure |
Group I (auto HSCT tbo-filgrastim)
n=38 Participants
Beginning on day 3 after auto Hematopoietic Cell Transplantation (HSCT), patients receive tbo-filgrastim SC daily for 12-14 days.
Hematopoietic Cell Transplantation: Undergo auto HSCT
Tbo-filgrastim: Given subcutaneously
Laboratory Biomarker Analysis: Correlative Studies
|
Group II (auto HSCT)
n=39 Participants
Patients undergo auto Hematopoietic Cell Transplantation (HSCT).
Hematopoietic Cell Transplantation: Undergo auto HSCT
Laboratory Biomarker Analysis: Correlative Studies
|
|---|---|---|
|
Median Number of Days of Febrile Neutropenia During the Auto HSCT Inpatient Stay
|
2 days of inpatient febrile neutropenia
Interval 0.0 to 6.0
|
4 days of inpatient febrile neutropenia
Interval 1.0 to 9.0
|
SECONDARY outcome
Timeframe: Up to 60 daysWill be defined as a positive blood culture not ultimately deemed to be due to a contaminant
Outcome measures
| Measure |
Group I (auto HSCT tbo-filgrastim)
n=38 Participants
Beginning on day 3 after auto Hematopoietic Cell Transplantation (HSCT), patients receive tbo-filgrastim SC daily for 12-14 days.
Hematopoietic Cell Transplantation: Undergo auto HSCT
Tbo-filgrastim: Given subcutaneously
Laboratory Biomarker Analysis: Correlative Studies
|
Group II (auto HSCT)
n=39 Participants
Patients undergo auto Hematopoietic Cell Transplantation (HSCT).
Hematopoietic Cell Transplantation: Undergo auto HSCT
Laboratory Biomarker Analysis: Correlative Studies
|
|---|---|---|
|
Median Number of Documented Infections Treatment During the Auto HSCT Inpatient Stay
|
0 documented inpatient stay infections
Interval 0.0 to 3.0
|
0 documented inpatient stay infections
Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: Up to 60 daysWill be summarized by treatment arm and compared using Wilcoxon rank sum tests.
Outcome measures
| Measure |
Group I (auto HSCT tbo-filgrastim)
n=38 Participants
Beginning on day 3 after auto Hematopoietic Cell Transplantation (HSCT), patients receive tbo-filgrastim SC daily for 12-14 days.
Hematopoietic Cell Transplantation: Undergo auto HSCT
Tbo-filgrastim: Given subcutaneously
Laboratory Biomarker Analysis: Correlative Studies
|
Group II (auto HSCT)
n=39 Participants
Patients undergo auto Hematopoietic Cell Transplantation (HSCT).
Hematopoietic Cell Transplantation: Undergo auto HSCT
Laboratory Biomarker Analysis: Correlative Studies
|
|---|---|---|
|
Median Number of Antibiotic Days During the Auto HSCT Inpatient Stay
|
4 antibiotic inpatient days
Interval 0.0 to 14.0
|
7 antibiotic inpatient days
Interval 2.0 to 16.0
|
SECONDARY outcome
Timeframe: Up to 60 daysPopulation: Protocol initially stated that median number of days on corticosteroids will be summarized by treatment arm and compared using Wilcoxon rank sum tests up to 60 days; data reported as Steroids initiated percentage
will be presented as percentage of number of subjects who had the treatment
Outcome measures
| Measure |
Group I (auto HSCT tbo-filgrastim)
n=38 Participants
Beginning on day 3 after auto Hematopoietic Cell Transplantation (HSCT), patients receive tbo-filgrastim SC daily for 12-14 days.
Hematopoietic Cell Transplantation: Undergo auto HSCT
Tbo-filgrastim: Given subcutaneously
Laboratory Biomarker Analysis: Correlative Studies
|
Group II (auto HSCT)
n=39 Participants
Patients undergo auto Hematopoietic Cell Transplantation (HSCT).
Hematopoietic Cell Transplantation: Undergo auto HSCT
Laboratory Biomarker Analysis: Correlative Studies
|
|---|---|---|
|
Percentage of Participants Receiving Corticosteroids
|
31.4 percentage of patients
|
51.4 percentage of patients
|
SECONDARY outcome
Timeframe: Up to 60 daysPopulation: Protocol initially stated that number of post discharge granulocyte colony-stimulating factor administrations through day +60 post auto HSCT will be summarized by treatment arm and compared using Wilcoxon rank sum tests up to 60 days; data available is reported as reported as number with G-CSF
will be presented as percentage of number of subjects who had the treatment
Outcome measures
| Measure |
Group I (auto HSCT tbo-filgrastim)
n=38 Participants
Beginning on day 3 after auto Hematopoietic Cell Transplantation (HSCT), patients receive tbo-filgrastim SC daily for 12-14 days.
Hematopoietic Cell Transplantation: Undergo auto HSCT
Tbo-filgrastim: Given subcutaneously
Laboratory Biomarker Analysis: Correlative Studies
|
Group II (auto HSCT)
n=39 Participants
Patients undergo auto Hematopoietic Cell Transplantation (HSCT).
Hematopoietic Cell Transplantation: Undergo auto HSCT
Laboratory Biomarker Analysis: Correlative Studies
|
|---|---|---|
|
Percentage of Participants With Post Discharge Granulocyte Colony-stimulating Factor Administrations Through Day +60 Post Auto HSCT
|
5.7 Percentage of Participants
|
8.6 Percentage of Participants
|
Adverse Events
Group I (auto HSCT tbo-filgrastim)
Serious events: 6 serious events
Other events: 37 other events
Deaths: 6 deaths
Group II (auto HSCT)
Serious events: 10 serious events
Other events: 39 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Group I (auto HSCT tbo-filgrastim)
n=37 participants at risk
Beginning on day 3 after auto Hematopoietic Cell Transplantation (HSCT), patients receive tbo-filgrastim SC daily for 12-14 days.
Hematopoietic Cell Transplantation: Undergo auto HSCT
Tbo-filgrastim: Given subcutaneously
Laboratory Biomarker Analysis: Correlative Studies
|
Group II (auto HSCT)
n=39 participants at risk
Patients undergo auto Hematopoietic Cell Transplantation (HSCT).
Hematopoietic Cell Transplantation: Undergo auto HSCT
Laboratory Biomarker Analysis: Correlative Studies
|
|---|---|---|
|
Vascular disorders
Hypoxia
|
13.5%
5/37 • Number of events 5 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Blood and lymphatic system disorders
Hypoglycemia
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Blood and lymphatic system disorders
Asparte aminotransferase
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Blood and lymphatic system disorders
Alanine aminotransferase increased
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Vascular disorders
syncope
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Blood and lymphatic system disorders
Typhlitis
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Vascular disorders
hypotension
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
5.1%
2/39 • Number of events 2 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Gastrointestinal disorders
Small Bowel Obstruction
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Gastrointestinal disorders
Colitis
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
General disorders
infection/infestation
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Immune system disorders
Engraftment syndrome
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Hepatobiliary disorders
Urinary tract infection
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Blood and lymphatic system disorders
AST increase
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
Other adverse events
| Measure |
Group I (auto HSCT tbo-filgrastim)
n=37 participants at risk
Beginning on day 3 after auto Hematopoietic Cell Transplantation (HSCT), patients receive tbo-filgrastim SC daily for 12-14 days.
Hematopoietic Cell Transplantation: Undergo auto HSCT
Tbo-filgrastim: Given subcutaneously
Laboratory Biomarker Analysis: Correlative Studies
|
Group II (auto HSCT)
n=39 participants at risk
Patients undergo auto Hematopoietic Cell Transplantation (HSCT).
Hematopoietic Cell Transplantation: Undergo auto HSCT
Laboratory Biomarker Analysis: Correlative Studies
|
|---|---|---|
|
Gastrointestinal disorders
diverticulitis grade 1
|
5.4%
2/37 • Number of events 2 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
General disorders
diverticulitis grade 2
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Gastrointestinal disorders
dry mouth
|
13.5%
5/37 • Number of events 5 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
15.4%
6/39 • Number of events 6 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Gastrointestinal disorders
DYSGEUSIA
|
10.8%
4/37 • Number of events 4 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Gastrointestinal disorders
elevated ALT grade 1
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Gastrointestinal disorders
elevated ALT grade 2
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Gastrointestinal disorders
dyspepsia grade 2
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Gastrointestinal disorders
elevated LDH
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Gastrointestinal disorders
elevated liver function test grade 2
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Gastrointestinal disorders
EPIGASTRIC BURNING
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Gastrointestinal disorders
EPIGASTRIC TIGHTNESS
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Gastrointestinal disorders
ESOPHAGEAL SPASMS grade 2
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Gastrointestinal disorders
Fistula
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Gastrointestinal disorders
Flatulence grade 1
|
18.9%
7/37 • Number of events 7 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
7.7%
3/39 • Number of events 3 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Gastrointestinal disorders
Flatulence grade 2
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Gastrointestinal disorders
gas distention
|
16.2%
6/37 • Number of events 6 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
20.5%
8/39 • Number of events 8 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Gastrointestinal disorders
gastritis
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Gastrointestinal disorders
GERD
|
32.4%
12/37 • Number of events 12 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
28.2%
11/39 • Number of events 11 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Gastrointestinal disorders
HEMORRHOIDS
|
5.4%
2/37 • Number of events 2 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
5.1%
2/39 • Number of events 2 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Gastrointestinal disorders
HEPTOBILIARY DISORDER Grade 3
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Gastrointestinal disorders
hiccups
|
10.8%
4/37 • Number of events 4 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Gastrointestinal disorders
irritable bowel syndrome
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Gastrointestinal disorders
ICTERUS/JAUNDICE
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Gastrointestinal disorders
indigestion
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
5.1%
2/39 • Number of events 2 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Gastrointestinal disorders
JAW TENDERNESS
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Gastrointestinal disorders
LOWER GI HEMORRHAGE grade 3
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Gastrointestinal disorders
mouth sores
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Gastrointestinal disorders
MUCOSITIS Grade 1
|
37.8%
14/37 • Number of events 14 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
35.9%
14/39 • Number of events 14 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Gastrointestinal disorders
MUCOSITIS Grade 2
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
7.7%
3/39 • Number of events 3 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Gastrointestinal disorders
MUCOSITIS Grade 3
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Gastrointestinal disorders
nausea grade 1
|
81.1%
30/37 • Number of events 30 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
82.1%
32/39 • Number of events 32 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Gastrointestinal disorders
nausea grade 2
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Gastrointestinal disorders
obesity
|
8.1%
3/37 • Number of events 3 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
12.8%
5/39 • Number of events 5 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Gastrointestinal disorders
Ostomy prolapse
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Gastrointestinal disorders
SMALL BOWEL OBSTRUCTION Grade 2
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Gastrointestinal disorders
Small intestine obstruction Grade 3
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Gastrointestinal disorders
TROUBLE SWALLOWING
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Gastrointestinal disorders
TYPHILITIS Grade 3
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Gastrointestinal disorders
ULCER SUBLINGUAL
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Gastrointestinal disorders
vomiting grade 1
|
43.2%
16/37 • Number of events 16 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
33.3%
13/39 • Number of events 13 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Gastrointestinal disorders
vomiting grade 2
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Endocrine disorders
alopecia
|
40.5%
15/37 • Number of events 15 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
20.5%
8/39 • Number of events 8 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Endocrine disorders
DECREASED/ LOSS OF APPETITE grade 1
|
64.9%
24/37 • Number of events 24 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
43.6%
17/39 • Number of events 17 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Endocrine disorders
DECREASED/ LOSS OF APPETITE grade 2
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Endocrine disorders
DIABETES
|
18.9%
7/37 • Number of events 7 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
5.1%
2/39 • Number of events 2 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Endocrine disorders
HYPOGLYCEMIA
|
5.4%
2/37 • Number of events 2 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Endocrine disorders
HYPOTHYROIDISM
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
5.1%
2/39 • Number of events 2 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Immune system disorders
LYMPHEDEMA
|
5.4%
2/37 • Number of events 2 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Endocrine disorders
WEIGHT GAIN
|
5.4%
2/37 • Number of events 2 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Blood and lymphatic system disorders
alkaline grade 2
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Blood and lymphatic system disorders
leukocytosis
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Immune system disorders
allergies
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
5.1%
2/39 • Number of events 2 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Immune system disorders
chills grade 1
|
27.0%
10/37 • Number of events 10 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
33.3%
13/39 • Number of events 13 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Immune system disorders
chills grade 2
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Immune system disorders
fever grade 1
|
73.0%
27/37 • Number of events 27 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
66.7%
26/39 • Number of events 26 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Immune system disorders
fever grade 2
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
5.1%
2/39 • Number of events 2 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Immune system disorders
HYPOGAMMAGLOBULINEMIA
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Infections and infestations
infection grade 1
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Infections and infestations
infection grade 2
|
5.4%
2/37 • Number of events 2 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Infections and infestations
infection grade 3
|
8.1%
3/37 • Number of events 3 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Infections and infestations
NEUTROPENIC SEPSIS
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Skin and subcutaneous tissue disorders
HYPERPIGMENTATION
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Skin and subcutaneous tissue disorders
IV SITE
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Skin and subcutaneous tissue disorders
PRURITIS-ITCH GRADE 1
|
13.5%
5/37 • Number of events 5 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
17.9%
7/39 • Number of events 7 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Skin and subcutaneous tissue disorders
PRURITIS-ITCH GRADE 2
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Skin and subcutaneous tissue disorders
Rash Grade 1
|
45.9%
17/37 • Number of events 17 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
30.8%
12/39 • Number of events 12 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Skin and subcutaneous tissue disorders
Rash Grade 2
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Skin and subcutaneous tissue disorders
SUBCUTANEOUS TISSUE DISORDER
|
5.4%
2/37 • Number of events 2 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Skin and subcutaneous tissue disorders
wound
|
5.4%
2/37 • Number of events 2 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Immune system disorders
enlarged lymph nodes
|
5.4%
2/37 • Number of events 2 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Metabolism and nutrition disorders
weight loss
|
8.1%
3/37 • Number of events 3 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
5.1%
2/39 • Number of events 2 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Musculoskeletal and connective tissue disorders
ARM PAIN
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Musculoskeletal and connective tissue disorders
ARM TWITCHING
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
32.4%
12/37 • Number of events 12 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
12.8%
5/39 • Number of events 5 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS R HIP
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN Grade 1
|
8.1%
3/37 • Number of events 3 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
30.8%
12/39 • Number of events 12 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN Grade 2
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
25.6%
10/39 • Number of events 10 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Eye disorders
BLIND IN LEFT EYE
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
7.7%
3/39 • Number of events 3 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Musculoskeletal and connective tissue disorders
BRUISES/BLEEDS
|
5.4%
2/37 • Number of events 2 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Musculoskeletal and connective tissue disorders
BUTTOCK PAIN
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Eye disorders
CATARACT
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Musculoskeletal and connective tissue disorders
CHEST TIGHTNESS
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Musculoskeletal and connective tissue disorders
CHIN NUMBNESS
|
5.4%
2/37 • Number of events 2 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Eye disorders
EYE DISCHARGE
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Musculoskeletal and connective tissue disorders
COMPRESSION FRACTURE
|
5.4%
2/37 • Number of events 2 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Musculoskeletal and connective tissue disorders
FACIAL SWELLING
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Eye disorders
DRY EYE
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Ear and labyrinth disorders
EAR PAIN
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Musculoskeletal and connective tissue disorders
EXTREMITY WEAKNESS
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Eye disorders
EYE IRRITATION
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
5.1%
2/39 • Number of events 2 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Eye disorders
EYE SWELLING
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
5.1%
2/39 • Number of events 2 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Musculoskeletal and connective tissue disorders
Fall grade 2
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Musculoskeletal and connective tissue disorders
FACIAL FLUSHING
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Musculoskeletal and connective tissue disorders
FACIAL ASYMMETRY
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
General disorders
FATIGUE
|
86.5%
32/37 • Number of events 32 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
33.3%
13/39 • Number of events 13 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Musculoskeletal and connective tissue disorders
FLANK PAIN
|
5.4%
2/37 • Number of events 2 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Musculoskeletal and connective tissue disorders
GAIT PROBLEM Grade 1
|
5.4%
2/37 • Number of events 2 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Musculoskeletal and connective tissue disorders
GAIT PROBLEM Grade 2
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Musculoskeletal and connective tissue disorders
Gout
|
8.1%
3/37 • Number of events 3 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Musculoskeletal and connective tissue disorders
HAND SPASM
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Ear and labyrinth disorders
HEARING LOSS
|
5.4%
2/37 • Number of events 2 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
7.7%
3/39 • Number of events 3 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Musculoskeletal and connective tissue disorders
HEEL SPUR PAIN
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Musculoskeletal and connective tissue disorders
HIP PAIN
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Blood and lymphatic system disorders
HYPOMAGNESEMIA
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Musculoskeletal and connective tissue disorders
JAW PAIN
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Musculoskeletal and connective tissue disorders
JOINT SWELLING Grade 1
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Musculoskeletal and connective tissue disorders
JOINT SWELLING Grade 2
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Musculoskeletal and connective tissue disorders
KNEE PAIN Grade 2
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Musculoskeletal and connective tissue disorders
KYPHOSIS
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Musculoskeletal and connective tissue disorders
L HAND SWELLING/TENDERNESS
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Ear and labyrinth disorders
LEFT EAR FULLNESS
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Eye disorders
LEFT GAZE PALSY
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Musculoskeletal and connective tissue disorders
LEG CRAMPS
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Musculoskeletal and connective tissue disorders
LEG WEAKNESS
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
16.2%
6/37 • Number of events 6 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Musculoskeletal and connective tissue disorders
NECK STIFFNESS
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Musculoskeletal and connective tissue disorders
NON-CARDIAC CHEST PAIN
|
5.4%
2/37 • Number of events 2 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
8.1%
3/37 • Number of events 3 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Musculoskeletal and connective tissue disorders
osteopenia
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Musculoskeletal and connective tissue disorders
PAIN-PICC SITE
|
5.4%
2/37 • Number of events 2 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Musculoskeletal and connective tissue disorders
PELVIS-BURNING PRESSURE
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Musculoskeletal and connective tissue disorders
PERI-ANAL ITCHING
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Musculoskeletal and connective tissue disorders
PETECHHIAE OF BILATERAL CALVES
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Eye disorders
RED EYE
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Musculoskeletal and connective tissue disorders
R HAND SWELLING
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Musculoskeletal and connective tissue disorders
R THIGH PAIN
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Musculoskeletal and connective tissue disorders
RIB PAIN
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Musculoskeletal and connective tissue disorders
SHOULDER PAIN
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Musculoskeletal and connective tissue disorders
SORENESS BILATERAL LEGS
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Eye disorders
STYE OF RIGHT EYELID
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Musculoskeletal and connective tissue disorders
SWELLING
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Musculoskeletal and connective tissue disorders
WEAKNESS GRADE 1
|
18.9%
7/37 • Number of events 7 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
17.9%
7/39 • Number of events 7 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Musculoskeletal and connective tissue disorders
WEAKNESS GRADE 2
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Nervous system disorders
ADHD
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Nervous system disorders
ANXIETY GRADE 1
|
21.6%
8/37 • Number of events 8 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
25.6%
10/39 • Number of events 10 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Nervous system disorders
ANXIETY GRADE 2
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Nervous system disorders
AGITATION GRADE 2
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Nervous system disorders
BIPOLAR DSORDER
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Eye disorders
BLURRED VISION
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Eye disorders
CONJUNCTIVITIS
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Nervous system disorders
CONFUSION GRADE 1
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
7.7%
3/39 • Number of events 3 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Nervous system disorders
CONFUSION GRADE 2
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Nervous system disorders
DEPRESSION
|
10.8%
4/37 • Number of events 4 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
15.4%
6/39 • Number of events 6 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Nervous system disorders
DIAPHORESIS
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Nervous system disorders
DIZZINESS GRADE 1
|
24.3%
9/37 • Number of events 9 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
20.5%
8/39 • Number of events 8 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Nervous system disorders
DIZZINESS GRADE 2
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Eye disorders
DOUBLE VISION
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Nervous system disorders
FLAT AFFECT
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Nervous system disorders
FLUSHING
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Eye disorders
GLAUCOMA
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Nervous system disorders
HALLUCINATIONS GRADE 1
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Nervous system disorders
HALLUCINATIONS GRADE 2
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Nervous system disorders
HEADACHE
|
24.3%
9/37 • Number of events 9 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
10.3%
4/39 • Number of events 4 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Nervous system disorders
HERPETIC POLYNEUROPATHY
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Endocrine disorders
HOT FLASHES
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
General disorders
INSOMNIA
|
37.8%
14/37 • Number of events 14 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
10.3%
4/39 • Number of events 4 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
General disorders
INSOMNIA GRADE 2
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
General disorders
LEFT FACIAL DROOP
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Nervous system disorders
LIGHTHEADED GRADE 1
|
5.4%
2/37 • Number of events 2 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
7.7%
3/39 • Number of events 3 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Nervous system disorders
LIGHTHEADED GRADE 2
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Musculoskeletal and connective tissue disorders
LIP QUIVER
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Psychiatric disorders
MAJOR DEPRESSIVE DISORDER
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Nervous system disorders
MIGRAINE
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Nervous system disorders
NEUROPATHY GRADE 1
|
35.1%
13/37 • Number of events 13 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
20.5%
8/39 • Number of events 8 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Nervous system disorders
NEUROPATHY GRADE 2
|
8.1%
3/37 • Number of events 3 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Nervous system disorders
NUMBNESS
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Nervous system disorders
NYSTAGMUS GRADE 2
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Eye disorders
PALE CONJUNCTIVAE
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Reproductive system and breast disorders
PRURITIS-VAGINAL
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Skin and subcutaneous tissue disorders
BURNING-TOES
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Skin and subcutaneous tissue disorders
DERMATITIS
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Skin and subcutaneous tissue disorders
DUPUYTRENS DISEASE
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Skin and subcutaneous tissue disorders
EDEMATOUS SKIN
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
5.4%
2/37 • Number of events 2 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
10.3%
4/39 • Number of events 4 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Skin and subcutaneous tissue disorders
FOLLICULITIS
|
5.4%
2/37 • Number of events 2 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Reproductive system and breast disorders
SCROTAL EDEMA
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Reproductive system and breast disorders
VAGINAL DISCHARGE
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
5.4%
2/37 • Number of events 2 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Reproductive system and breast disorders
BPH
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Respiratory, thoracic and mediastinal disorders
ATELECTASIS
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM GRADE 2
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Respiratory, thoracic and mediastinal disorders
RALES
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Respiratory, thoracic and mediastinal disorders
RHINITIS
|
8.1%
3/37 • Number of events 3 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHEA
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Respiratory, thoracic and mediastinal disorders
SLEEP APNEA
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Respiratory, thoracic and mediastinal disorders
SNEEZING
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Respiratory, thoracic and mediastinal disorders
SORE THROAT
|
16.2%
6/37 • Number of events 6 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
5.1%
2/39 • Number of events 2 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Respiratory, thoracic and mediastinal disorders
TACHYPNEA GRADE 1
|
5.4%
2/37 • Number of events 2 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Respiratory, thoracic and mediastinal disorders
TACHYPNEA GRADE 2
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Respiratory, thoracic and mediastinal disorders
WHEEZING
|
8.1%
3/37 • Number of events 3 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
5.1%
2/39 • Number of events 2 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Renal and urinary disorders
BLADDER OUTLET OBSTRUCTION GRADE 2
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Renal and urinary disorders
AKI
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Renal and urinary disorders
BPH
|
32.4%
12/37 • Number of events 12 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Renal and urinary disorders
CKD
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Renal and urinary disorders
CKD GRADE 2
|
5.4%
2/37 • Number of events 2 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Renal and urinary disorders
DEHYDRATION
|
5.4%
2/37 • Number of events 2 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
5.1%
2/39 • Number of events 2 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Renal and urinary disorders
DIFFICULTY URINATING
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Renal and urinary disorders
DYSURIA GRADE 1
|
8.1%
3/37 • Number of events 3 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
7.7%
3/39 • Number of events 3 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Renal and urinary disorders
DYSURIA GRADE 2
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Renal and urinary disorders
HEMATURIA GRADE 1
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Renal and urinary disorders
HEMATURIA GRADE 2
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Renal and urinary disorders
HYDRONEPHROSIS
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Blood and lymphatic system disorders
HYPERKALEMIA
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Renal and urinary disorders
HYPERVOLEMIA GRADE 2
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Renal and urinary disorders
INCONTINENCE
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Blood and lymphatic system disorders
HYPOKALEMIA
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Renal and urinary disorders
LUPUS NEPHRITIS
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Renal and urinary disorders
METABOLIC ACIDOSIS
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Renal and urinary disorders
NOCTURIA
|
35.1%
13/37 • Number of events 13 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
10.3%
4/39 • Number of events 4 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Renal and urinary disorders
MYELOMA KIDNEY DISEASE
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Renal and urinary disorders
OVERACTIVE BLADDER
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Reproductive system and breast disorders
VAGINAL SPOTTING/CRAMPS
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Renal and urinary disorders
RENAL DISORDER
|
5.4%
2/37 • Number of events 2 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Renal and urinary disorders
URINARY HESITANCY
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Renal and urinary disorders
URINARY FREQUENCY
|
16.2%
6/37 • Number of events 6 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
12.8%
5/39 • Number of events 5 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Renal and urinary disorders
URINARY RETENTION
|
13.5%
5/37 • Number of events 5 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Blood and lymphatic system disorders
Anemia
|
5.4%
2/37 • Number of events 2 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Cardiac disorders
Aortic Stenosis Grade 2
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Cardiac disorders
asymptomatic LV dysfunction
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Blood and lymphatic system disorders
B12 deficiency
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Cardiac disorders
bradycardia
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Cardiac disorders
cardiomyopathy
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Cardiac disorders
coronary artery disease
|
5.4%
2/37 • Number of events 2 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Cardiac disorders
chest pain grade 1
|
5.4%
2/37 • Number of events 2 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Cardiac disorders
chest pain grade 2
|
5.4%
2/37 • Number of events 2 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Cardiac disorders
deep vein thrombosis grade 1
|
5.4%
2/37 • Number of events 2 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
5.1%
2/39 • Number of events 2 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Cardiac disorders
deep vein thrombosis grade 2
|
5.4%
2/37 • Number of events 2 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Blood and lymphatic system disorders
dyslipidemia
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Cardiac disorders
edema grade 1
|
54.1%
20/37 • Number of events 20 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
30.8%
12/39 • Number of events 12 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Cardiac disorders
edema grade 2
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Blood and lymphatic system disorders
Hypercholesterolemia
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Blood and lymphatic system disorders
hyperlipidemia
|
13.5%
5/37 • Number of events 5 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Blood and lymphatic system disorders
hypergylcemia
|
13.5%
5/37 • Number of events 5 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Cardiac disorders
hypertension grade 1
|
43.2%
16/37 • Number of events 26 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
33.3%
13/39 • Number of events 13 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Cardiac disorders
hypertension grade 2
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Cardiac disorders
hypotension Grade 1
|
48.6%
18/37 • Number of events 18 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
17.9%
7/39 • Number of events 7 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Cardiac disorders
hypotension grade 2
|
8.1%
3/37 • Number of events 3 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
5.1%
2/39 • Number of events 2 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Cardiac disorders
hypotension grade 3
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
5.1%
2/39 • Number of events 2 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Cardiac disorders
hypotension grade 4
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Cardiac disorders
hypoxia grade 2
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Cardiac disorders
hypoxia grade 3
|
13.5%
5/37 • Number of events 5 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Cardiac disorders
hypoxia grade 5
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Cardiac disorders
Infusion Related Reaction Grade 1
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
5.1%
2/39 • Number of events 2 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Cardiac disorders
tacycardia
|
40.5%
15/37 • Number of events 15 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
38.5%
15/39 • Number of events 15 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Gastrointestinal disorders
DIARRHEA Grade 2
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
10.3%
4/39 • Number of events 4 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Cardiac disorders
infusion related reaction grade 2
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Cardiac disorders
murmur
|
8.1%
3/37 • Number of events 3 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
7.7%
3/39 • Number of events 3 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Blood and lymphatic system disorders
normocytic anemia
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Cardiac disorders
palpitations
|
8.1%
3/37 • Number of events 3 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
7.7%
3/39 • Number of events 3 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Cardiac disorders
supraventriculartachycardia grade2
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Cardiac disorders
supraventriculartachycardia grade 4
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Cardiac disorders
stroke grade 4
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Surgical and medical procedures
PERICATHETER THROMBUS
|
5.4%
2/37 • Number of events 2 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Cardiac disorders
premature ventricular contractions
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Respiratory, thoracic and mediastinal disorders
shortness of breath
|
16.2%
6/37 • Number of events 6 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
12.8%
5/39 • Number of events 5 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Cardiac disorders
thromboembolic event grade1
|
8.1%
3/37 • Number of events 3 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Cardiac disorders
thromboembolic event grade 2
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Cardiac disorders
thromboembolic event grade 4
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Gastrointestinal disorders
abdominal cramps
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Gastrointestinal disorders
abdominal pain grade 1
|
45.9%
17/37 • Number of events 17 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
33.3%
13/39 • Number of events 13 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
General disorders
abdominal pain grade 2
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
5.1%
2/39 • Number of events 2 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Gastrointestinal disorders
abdominal swelling
|
8.1%
3/37 • Number of events 3 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
5.1%
2/39 • Number of events 2 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Gastrointestinal disorders
altered taste
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Gastrointestinal disorders
anorexia grade 2
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Gastrointestinal disorders
belching
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
5.1%
2/39 • Number of events 2 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Gastrointestinal disorders
blisters in mouth
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Gastrointestinal disorders
bloating
|
18.9%
7/37 • Number of events 7 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
5.1%
2/39 • Number of events 2 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Gastrointestinal disorders
bloody stools
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Gastrointestinal disorders
c-diff infection
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Gastrointestinal disorders
colitis grade 1
|
5.4%
2/37 • Number of events 2 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
5.1%
2/39 • Number of events 2 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Gastrointestinal disorders
colitis grade 2
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Gastrointestinal disorders
colon polyps
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Gastrointestinal disorders
constipation
|
40.5%
15/37 • Number of events 15 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
46.2%
18/39 • Number of events 18 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Gastrointestinal disorders
DIARRHEA Grade 1
|
83.8%
31/37 • Number of events 31 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
53.8%
21/39 • Number of events 21 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Cardiac disorders
Atrial Fibrillation (Grade 3)
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Cardiac disorders
Atrial Fibrillation (grade1)
|
5.4%
2/37 • Number of events 2 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Cardiac disorders
Atrial Fibrillation ( grade 2)
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PERIPHERAL NEUROPATHY
|
5.4%
2/37 • Number of events 2 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Nervous system disorders
PAIN/MYALGIA GRADE 1
|
32.4%
12/37 • Number of events 12 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
15.4%
6/39 • Number of events 6 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Nervous system disorders
PAIN/MYALGIA GRADE 2
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
7.7%
3/39 • Number of events 3 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Nervous system disorders
PLOYNEUROPATHY
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Nervous system disorders
PRESYNCOPE GRADE 2
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
General disorders
RIGHT FACIAL DROOP
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Nervous system disorders
RIGORS GRADE 1
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
7.7%
3/39 • Number of events 3 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Nervous system disorders
RIGORS GRADE 2
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Nervous system disorders
SYNCOPE GRADE 3
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Nervous system disorders
SCIATIC PAIN
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Nervous system disorders
SLURRED SPEECH
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Nervous system disorders
TINNITUS
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
5.1%
2/39 • Number of events 2 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Nervous system disorders
TREMORS
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Reproductive system and breast disorders
ERECTILE DYSFUNCTION
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Reproductive system and breast disorders
FIBROIDS
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Reproductive system and breast disorders
PENILE BLEEDING
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Reproductive system and breast disorders
PENILE RASH
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Respiratory, thoracic and mediastinal disorders
ATELECTASIS BILATERAL LOWER LOBE
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Respiratory, thoracic and mediastinal disorders
COPD
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
29.7%
11/37 • Number of events 11 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
20.5%
8/39 • Number of events 8 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Respiratory, thoracic and mediastinal disorders
COURSE BREATH SOUNDS
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Respiratory, thoracic and mediastinal disorders
CRACKLES @ BASES
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Respiratory, thoracic and mediastinal disorders
DEEP BREATHING
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Respiratory, thoracic and mediastinal disorders
DRY THROAT
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA ON EXERTION
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
10.8%
4/37 • Number of events 4 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
7.7%
3/39 • Number of events 3 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Respiratory, thoracic and mediastinal disorders
EXERCISE INDUCED ASTHMA
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Respiratory, thoracic and mediastinal disorders
HEMOPTYSIS
|
5.4%
2/37 • Number of events 2 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
8.1%
3/37 • Number of events 3 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
5.1%
2/39 • Number of events 2 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive Sleep apnea
|
2.7%
1/37 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS GRADE 2
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Respiratory, thoracic and mediastinal disorders
POST NASAL DRIP
|
5.4%
2/37 • Number of events 2 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
0.00%
0/39 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
|
Respiratory, thoracic and mediastinal disorders
POST NASAL DRIP GRADE 2
|
0.00%
0/37 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
2.6%
1/39 • Number of events 1 • Patients will be followed for adverse events for 60 days post-Auto HSCT
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place