Trial Outcomes & Findings for Pasireotide in Prevention of GI Toxicity (NCT NCT02215070)
NCT ID: NCT02215070
Last Updated: 2021-11-17
Results Overview
Number of participants who experience grades III-IV GI toxicity
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
37 participants
Primary outcome timeframe
30 Days
Results posted on
2021-11-17
Participant Flow
5 enrolled participants screen failed, 5 withdrew, and 1 was withdrawn by physician decision.
Participant milestones
| Measure |
Pasireotide + Preparatory Regimen
Eligible subjects will receive pasireotide daily for 5 days before stem cell transplant, the day of the stem cell transplant, and daily for 8 days following the stem cell transplant. Preparatory regimen will be given 4 days before stem cell transplant.
|
Historical Controls
Contemporaneous controls were matched using the following parameters: Transplant diagnosis (acute leukemias, lymphomas, myelodysplastic syndrome \[MDS\]/myeloproliferative neoplasm \[MPN\]/other), donor (related, unrelated), graft (bone marrow, peripheral blood progenitor cell \[PBPC\], and cord), GVHD prophylaxis (tacrolimus/methotrexate), age, hematopoietic cell transplantation-specific comorbidity index (HCT-CI), and conditioning regimen (TBI-based, chemotherapy only).
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
52
|
|
Overall Study
COMPLETED
|
20
|
52
|
|
Overall Study
NOT COMPLETED
|
6
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pasireotide in Prevention of GI Toxicity
Baseline characteristics by cohort
| Measure |
Pasireotide + Preparatory Regimen
n=26 Participants
Eligible subjects will receive pasireotide daily for 5 days before stem cell transplant, the day of the stem cell transplant, and daily for 8 days following the stem cell transplant. Preparatory regimen will be given 4 days before stem cell transplant.
|
Historical Controls
n=52 Participants
Contemporaneous controls were matched using the following parameters: Transplant diagnosis (acute leukemias, lymphomas, myelodysplastic syndrome \[MDS\]/myeloproliferative neoplasm \[MPN\]/other), donor (related, unrelated), graft (bone marrow, peripheral blood progenitor cell \[PBPC\], and cord), GVHD prophylaxis (tacrolimus/methotrexate), age, hematopoietic cell transplantation-specific comorbidity index (HCT-CI), and conditioning regimen (TBI-based, chemotherapy only).
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58 years
n=99 Participants
|
51 years
n=107 Participants
|
52 years
n=206 Participants
|
|
Sex: Female, Male
Gender · Female
|
8 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Sex: Female, Male
Gender · Male
|
18 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
72 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
66 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
26 Participants
n=99 Participants
|
52 Participants
n=107 Participants
|
78 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 30 DaysNumber of participants who experience grades III-IV GI toxicity
Outcome measures
| Measure |
Pasireotide + Preparatory Regimen
n=26 Participants
Eligible subjects will receive pasireotide daily for 5 days before stem cell transplant, the day of the stem cell transplant, and daily for 8 days following the stem cell transplant. Preparatory regimen will be given 4 days before stem cell transplant.
|
Historical Controls
Contemporaneous controls were matched using the following parameters: Transplant diagnosis (acute leukemias, lymphomas, myelodysplastic syndrome \[MDS\]/myeloproliferative neoplasm \[MPN\]/other), donor (related, unrelated), graft (bone marrow, peripheral blood progenitor cell \[PBPC\], and cord), GVHD prophylaxis (tacrolimus/methotrexate), age, hematopoietic cell transplantation-specific comorbidity index (HCT-CI), and conditioning regimen (TBI-based, chemotherapy only).
|
|---|---|---|
|
Percentage of GI Toxicity From the Preparatory Regimen and the GVHD Prophylaxis in Stem Cell Transplantation (SCT) Patients Who Are Treated With Pasireotide
|
21 Participants
|
—
|
SECONDARY outcome
Timeframe: 100 daysNumber of participants who experience acute GVHD
Outcome measures
| Measure |
Pasireotide + Preparatory Regimen
n=26 Participants
Eligible subjects will receive pasireotide daily for 5 days before stem cell transplant, the day of the stem cell transplant, and daily for 8 days following the stem cell transplant. Preparatory regimen will be given 4 days before stem cell transplant.
|
Historical Controls
Contemporaneous controls were matched using the following parameters: Transplant diagnosis (acute leukemias, lymphomas, myelodysplastic syndrome \[MDS\]/myeloproliferative neoplasm \[MPN\]/other), donor (related, unrelated), graft (bone marrow, peripheral blood progenitor cell \[PBPC\], and cord), GVHD prophylaxis (tacrolimus/methotrexate), age, hematopoietic cell transplantation-specific comorbidity index (HCT-CI), and conditioning regimen (TBI-based, chemotherapy only).
|
|---|---|---|
|
Percentage of Acute GVHD
|
15 Participants
|
—
|
SECONDARY outcome
Timeframe: 100 daysAssess maximum severity of acute GVHD scored as stage 1 (least severe) through stage 4 (most severe) using BMT CTN, 2013 standards
Outcome measures
| Measure |
Pasireotide + Preparatory Regimen
n=26 Participants
Eligible subjects will receive pasireotide daily for 5 days before stem cell transplant, the day of the stem cell transplant, and daily for 8 days following the stem cell transplant. Preparatory regimen will be given 4 days before stem cell transplant.
|
Historical Controls
Contemporaneous controls were matched using the following parameters: Transplant diagnosis (acute leukemias, lymphomas, myelodysplastic syndrome \[MDS\]/myeloproliferative neoplasm \[MPN\]/other), donor (related, unrelated), graft (bone marrow, peripheral blood progenitor cell \[PBPC\], and cord), GVHD prophylaxis (tacrolimus/methotrexate), age, hematopoietic cell transplantation-specific comorbidity index (HCT-CI), and conditioning regimen (TBI-based, chemotherapy only).
|
|---|---|---|
|
Maximum Severity of Acute GVHD Compared to Historical Controls
|
2 units on a scale
Interval 1.0 to 3.0
|
—
|
SECONDARY outcome
Timeframe: 1 yearMeasure the number of participants who experience chronic GVHD
Outcome measures
| Measure |
Pasireotide + Preparatory Regimen
n=26 Participants
Eligible subjects will receive pasireotide daily for 5 days before stem cell transplant, the day of the stem cell transplant, and daily for 8 days following the stem cell transplant. Preparatory regimen will be given 4 days before stem cell transplant.
|
Historical Controls
n=52 Participants
Contemporaneous controls were matched using the following parameters: Transplant diagnosis (acute leukemias, lymphomas, myelodysplastic syndrome \[MDS\]/myeloproliferative neoplasm \[MPN\]/other), donor (related, unrelated), graft (bone marrow, peripheral blood progenitor cell \[PBPC\], and cord), GVHD prophylaxis (tacrolimus/methotrexate), age, hematopoietic cell transplantation-specific comorbidity index (HCT-CI), and conditioning regimen (TBI-based, chemotherapy only).
|
|---|---|---|
|
Incidence of Chronic GVHD Compared to Historical Controls
|
16 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: 1 yearAssess maximum severity of chronic GVHD scored as none, mild, moderate or severe using 2014 NIH Consensus Criteria
Outcome measures
| Measure |
Pasireotide + Preparatory Regimen
n=26 Participants
Eligible subjects will receive pasireotide daily for 5 days before stem cell transplant, the day of the stem cell transplant, and daily for 8 days following the stem cell transplant. Preparatory regimen will be given 4 days before stem cell transplant.
|
Historical Controls
n=52 Participants
Contemporaneous controls were matched using the following parameters: Transplant diagnosis (acute leukemias, lymphomas, myelodysplastic syndrome \[MDS\]/myeloproliferative neoplasm \[MPN\]/other), donor (related, unrelated), graft (bone marrow, peripheral blood progenitor cell \[PBPC\], and cord), GVHD prophylaxis (tacrolimus/methotrexate), age, hematopoietic cell transplantation-specific comorbidity index (HCT-CI), and conditioning regimen (TBI-based, chemotherapy only).
|
|---|---|---|
|
Maximum Severity of Chronic GVHD Compared to Historical Controls
|
8 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 1 yearRate of overall survival of participants at one year post transplant
Outcome measures
| Measure |
Pasireotide + Preparatory Regimen
n=26 Participants
Eligible subjects will receive pasireotide daily for 5 days before stem cell transplant, the day of the stem cell transplant, and daily for 8 days following the stem cell transplant. Preparatory regimen will be given 4 days before stem cell transplant.
|
Historical Controls
n=52 Participants
Contemporaneous controls were matched using the following parameters: Transplant diagnosis (acute leukemias, lymphomas, myelodysplastic syndrome \[MDS\]/myeloproliferative neoplasm \[MPN\]/other), donor (related, unrelated), graft (bone marrow, peripheral blood progenitor cell \[PBPC\], and cord), GVHD prophylaxis (tacrolimus/methotrexate), age, hematopoietic cell transplantation-specific comorbidity index (HCT-CI), and conditioning regimen (TBI-based, chemotherapy only).
|
|---|---|---|
|
Overall Survival Compared to Historical Controls
|
63 percentage of participants
Interval 47.0 to 86.0
|
82 percentage of participants
Interval 72.0 to 93.0
|
SECONDARY outcome
Timeframe: 1 yearRate of disease free survival of participants at one year post transplant
Outcome measures
| Measure |
Pasireotide + Preparatory Regimen
n=26 Participants
Eligible subjects will receive pasireotide daily for 5 days before stem cell transplant, the day of the stem cell transplant, and daily for 8 days following the stem cell transplant. Preparatory regimen will be given 4 days before stem cell transplant.
|
Historical Controls
n=52 Participants
Contemporaneous controls were matched using the following parameters: Transplant diagnosis (acute leukemias, lymphomas, myelodysplastic syndrome \[MDS\]/myeloproliferative neoplasm \[MPN\]/other), donor (related, unrelated), graft (bone marrow, peripheral blood progenitor cell \[PBPC\], and cord), GVHD prophylaxis (tacrolimus/methotrexate), age, hematopoietic cell transplantation-specific comorbidity index (HCT-CI), and conditioning regimen (TBI-based, chemotherapy only).
|
|---|---|---|
|
Disease Free Survival Compared to Historical Controls
|
40 percentage of participants
Interval 25.0 to 65.0
|
78 percentage of participants
Interval 68.0 to 91.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 100 daysExploratory outcome-These levels will be evaluated as biomarkers of GI tract health and function in SCT patients and the correlation between these biomarkers and GI toxicity.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 14 daysExploratory outcome-Video capsule endoscopy will be performed in a subset of ten study participants on the last day study drug is administered. Images will be examined for evidence of the four following types of abnormalities: reddened/edema/villous blunting, erosion, ulcer and stenosis.
Outcome measures
Outcome data not reported
Adverse Events
Pasireotide + Preparatory Regimen
Serious events: 8 serious events
Other events: 26 other events
Deaths: 1 deaths
Historical Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pasireotide + Preparatory Regimen
n=26 participants at risk
Eligible subjects will receive pasireotide daily for 5 days before stem cell transplant, the day of the stem cell transplant, and daily for 8 days following the stem cell transplant. Preparatory regimen will be given 4 days before stem cell transplant.
|
Historical Controls
Contemporaneous controls were matched using the following parameters: Transplant diagnosis (acute leukemias, lymphomas, myelodysplastic syndrome \[MDS\]/myeloproliferative neoplasm \[MPN\]/other), donor (related, unrelated), graft (bone marrow, peripheral blood progenitor cell \[PBPC\], and cord), GVHD prophylaxis (tacrolimus/methotrexate), age, hematopoietic cell transplantation-specific comorbidity index (HCT-CI), and conditioning regimen (TBI-based, chemotherapy only).
|
|---|---|---|
|
Cardiac disorders
Mobitz - Type II AV Block
|
3.8%
1/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Gastrointestinal disorders
Enterocolitis
|
3.8%
1/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Hepatobiliary disorders
VOD
|
3.8%
1/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Nervous system disorders
Somnolence
|
3.8%
1/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Infections and infestations
Febrile Neutropenia
|
7.7%
2/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Infections and infestations
Infections and infestations - Other, specify; blood stream
|
3.8%
1/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Infections and infestations
Lung infection
|
3.8%
1/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
Other adverse events
| Measure |
Pasireotide + Preparatory Regimen
n=26 participants at risk
Eligible subjects will receive pasireotide daily for 5 days before stem cell transplant, the day of the stem cell transplant, and daily for 8 days following the stem cell transplant. Preparatory regimen will be given 4 days before stem cell transplant.
|
Historical Controls
Contemporaneous controls were matched using the following parameters: Transplant diagnosis (acute leukemias, lymphomas, myelodysplastic syndrome \[MDS\]/myeloproliferative neoplasm \[MPN\]/other), donor (related, unrelated), graft (bone marrow, peripheral blood progenitor cell \[PBPC\], and cord), GVHD prophylaxis (tacrolimus/methotrexate), age, hematopoietic cell transplantation-specific comorbidity index (HCT-CI), and conditioning regimen (TBI-based, chemotherapy only).
|
|---|---|---|
|
General disorders
Nasal Congestion
|
30.8%
8/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Infections and infestations
Otitis Media
|
3.8%
1/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Gastrointestinal disorders
Abdominal Pain
|
53.8%
14/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Gastrointestinal disorders
Anorexia
|
80.8%
21/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Gastrointestinal disorders
Bloating
|
19.2%
5/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Gastrointestinal disorders
Constipation
|
30.8%
8/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Gastrointestinal disorders
Diarrhea
|
92.3%
24/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Gastrointestinal disorders
Dysphagia
|
3.8%
1/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Gastrointestinal disorders
Dyspepsia
|
19.2%
5/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Gastrointestinal disorders
Dysgeusia
|
34.6%
9/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Immune system disorders
Allergic reaction
|
7.7%
2/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Cardiac disorders
Afib
|
0.00%
0/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Psychiatric disorders
Anxiety
|
26.9%
7/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
General disorders
Chills
|
3.8%
1/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Cardiac disorders
Sinus Bradycardia
|
26.9%
7/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Cardiac disorders
2nd deg AVB
|
3.8%
1/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
General disorders
Chest pain
|
7.7%
2/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Infections and infestations
Enterocolitis
|
19.2%
5/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
30.8%
8/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Renal and urinary disorders
Inreased Creatinine
|
19.2%
5/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
7.7%
2/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Eye disorders
Dry Eyes
|
7.7%
2/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
26.9%
7/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
General disorders
Epistaxis
|
7.7%
2/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Renal and urinary disorders
Dysuria
|
23.1%
6/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
General disorders
Bone Pain
|
3.8%
1/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Renal and urinary disorders
Bladder Spasm
|
3.8%
1/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
General disorders
Dehydration
|
3.8%
1/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Respiratory, thoracic and mediastinal disorders
URI
|
3.8%
1/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Nervous system disorders
Encephalopathy
|
23.1%
6/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
General disorders
Fatigue
|
76.9%
20/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Infections and infestations
Febrile Neutropenia
|
65.4%
17/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Infections and infestations
Fever
|
15.4%
4/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Eye disorders
Floaters
|
0.00%
0/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
General disorders
Fracture
|
3.8%
1/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Skin and subcutaneous tissue disorders
Folliculitis
|
0.00%
0/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
General disorders
Hiccups
|
0.00%
0/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Nervous system disorders
Hallucination
|
11.5%
3/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Nervous system disorders
Headache
|
42.3%
11/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Nervous system disorders
Intracranial Hemorrhage
|
0.00%
0/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Blood and lymphatic system disorders
Hematoma
|
0.00%
0/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
3.8%
1/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Renal and urinary disorders
Hematuria
|
3.8%
1/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Infections and infestations
HSV Reactivation
|
11.5%
3/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
11.5%
3/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
3.8%
1/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
26.9%
7/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Endocrine disorders
Hyperglycemia
|
46.2%
12/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.8%
1/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Vascular disorders
Hypertension
|
53.8%
14/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Vascular disorders
Hypotension
|
19.2%
5/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Immune system disorders
Infusion Reaction
|
11.5%
3/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
General disorders
Insomnia
|
15.4%
4/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Infections and infestations
Lung Infection
|
15.4%
4/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
General disorders
Myalgias
|
0.00%
0/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
General disorders
Pain in Extremity
|
3.8%
1/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
7.7%
2/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
General disorders
Pruritis
|
7.7%
2/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Infections and infestations
Joint Infection
|
0.00%
0/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
General disorders
Menorrhagia
|
0.00%
0/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Cardiac disorders
Pericardial effusion
|
3.8%
1/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
3.8%
1/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Cardiac disorders
Pulmonary Edema
|
15.4%
4/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Renal and urinary disorders
Prostatic Obstruction
|
3.8%
1/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Skin and subcutaneous tissue disorders
Acne Rash
|
3.8%
1/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
General disorders
Rhinorrhea
|
11.5%
3/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Skin and subcutaneous tissue disorders
Rash
|
73.1%
19/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Infections and infestations
Skin Infection
|
11.5%
3/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Infections and infestations
Catheter-Related Infection
|
23.1%
6/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
General disorders
Toe Trauma
|
3.8%
1/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Nervous system disorders
PRES
|
0.00%
0/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Infections and infestations
Sepsis
|
26.9%
7/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Blood and lymphatic system disorders
Thromboembolic event
|
3.8%
1/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Infections and infestations
Thrush
|
15.4%
4/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Renal and urinary disorders
Urinary incontinence
|
3.8%
1/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Infections and infestations
UTI
|
7.7%
2/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Renal and urinary disorders
Urinary Retention
|
11.5%
3/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Infections and infestations
Viremia
|
15.4%
4/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Hepatobiliary disorders
VOD
|
3.8%
1/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Hepatobiliary disorders
AST Elevation
|
7.7%
2/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Hepatobiliary disorders
ALT Elevation
|
7.7%
2/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Hepatobiliary disorders
Alk Phos Elevation
|
3.8%
1/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Hepatobiliary disorders
Bilirubin Elevation
|
23.1%
6/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Gastrointestinal disorders
Mucositis
|
92.3%
24/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Gastrointestinal disorders
Ileus
|
7.7%
2/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Gastrointestinal disorders
Nausea
|
96.2%
25/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Gastrointestinal disorders
Vomiting
|
76.9%
20/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
|
Gastrointestinal disorders
Bowel Obstruction
|
3.8%
1/26 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
—
0/0 • AEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place