Trial Outcomes & Findings for Chemotherapy, Imatinib Mesylate, and Peripheral Stem Cell Transplantation in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia (NCT NCT00039377)
NCT ID: NCT00039377
Last Updated: 2014-11-24
Results Overview
Disease-free survival (DFS) was measured as the interval from achievement of complete remission (CR) until relapse or death, regardless of cause; patients alive and in CR were censored at last follow-up. DFS was estimated using the Kaplan Meier method. A complete remission (CR) was defined as recovery of morphologically normal bone marrow and blood counts (i.e., neutrophils \>= 1.5 x 10\^9/L and platelets \> 100 x 10\^9/L) and no circulating leukemic blasts or evidence of extramedullary leukemia and persisting for at least one month.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
58 participants
Primary outcome timeframe
Duration of treatment (up to 10 years)
Results posted on
2014-11-24
Participant Flow
58 participants were recruited.
One participant was deemed ineligible and is excluded from all analyses per study design.
Participant milestones
| Measure |
Entire Cohort
All participants treatment on this study, see the Detailed Description for treatment information.
|
Patients With HLA-matched Sibling Donor in Course 5
Patients undergo courses I-IV as in Detailed Description. Beginning 3-10 days after completion of course IV, patients with an HLA-matched sibling donor undergo total body irradiation (TBI) 2-3 times daily on days -7 to -4. Patients receive etoposide IV over 4 hours on day -3. Patients then undergo PBSCT on day 0. Patients then receive graft-vs-host disease prophylaxis with tacrolimus IV continuously on days -1 to 56 (or IV continuously on days -1 to 14 and then PO or IV every 12 hours on days 15-56) followed by a taper. Patients also receive methotrexate IV on days 1, 3, and 6, and filgrastim (G-CSF) subcutaneously (SC) beginning on day 4 and continuing until blood counts recover. Patients then undergo course VI as in Detailed Description.
|
Patients Without HLA-matched Sibling Donors in Course V
Patients undergo courses I-IV as in Detailed Description. Beginning 3-10 days after completion of course IV, patients without an HLA-matched sibling donor receive etoposide IV continuously and cytarabine IV over 2 hours on days 1-4. Patients also receive G-CSF SC beginning on day 14 and continuing until PBSC collection is complete. Patients receive imatinib mesylate PO twice daily beginning after completion of PBSC collection and continuing until 3 days before PBSCT. Patients then undergo TBI 2-3 times daily on days -8 to -5. Patients receive etoposide IV over 4 hours on day -4 and cyclophosphamide IV over 2 hours on day -2. Patients undergo PBSCT on day 0. Patients receive G-CSF SC beginning on day 0 and continuing until blood counts recover. Patients then undergo course VI as in Detailed Description.
|
Patients Who Did Not Undergo Transplant for Course V
Patients undergo courses I-IV as in Detailed Description. Beginning 3-10 days after completion of course IV, patients who are not candidates for PBSCT receive etoposide IV over 4 hours and cytarabine IV over 2 hours on days 1-4. Patients also receive G-CSF SC once or twice a day beginning on day 14 and continuing until blood counts recover. Patients then undergo course VI as in Detailed Description.
|
|---|---|---|---|---|
|
Initial Registration
STARTED
|
57
|
0
|
0
|
0
|
|
Initial Registration
COMPLETED
|
35
|
0
|
0
|
0
|
|
Initial Registration
NOT COMPLETED
|
22
|
0
|
0
|
0
|
|
Course 5 (Transplant Assignments)
STARTED
|
0
|
15
|
19
|
1
|
|
Course 5 (Transplant Assignments)
COMPLETED
|
0
|
15
|
19
|
1
|
|
Course 5 (Transplant Assignments)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Entire Cohort
All participants treatment on this study, see the Detailed Description for treatment information.
|
Patients With HLA-matched Sibling Donor in Course 5
Patients undergo courses I-IV as in Detailed Description. Beginning 3-10 days after completion of course IV, patients with an HLA-matched sibling donor undergo total body irradiation (TBI) 2-3 times daily on days -7 to -4. Patients receive etoposide IV over 4 hours on day -3. Patients then undergo PBSCT on day 0. Patients then receive graft-vs-host disease prophylaxis with tacrolimus IV continuously on days -1 to 56 (or IV continuously on days -1 to 14 and then PO or IV every 12 hours on days 15-56) followed by a taper. Patients also receive methotrexate IV on days 1, 3, and 6, and filgrastim (G-CSF) subcutaneously (SC) beginning on day 4 and continuing until blood counts recover. Patients then undergo course VI as in Detailed Description.
|
Patients Without HLA-matched Sibling Donors in Course V
Patients undergo courses I-IV as in Detailed Description. Beginning 3-10 days after completion of course IV, patients without an HLA-matched sibling donor receive etoposide IV continuously and cytarabine IV over 2 hours on days 1-4. Patients also receive G-CSF SC beginning on day 14 and continuing until PBSC collection is complete. Patients receive imatinib mesylate PO twice daily beginning after completion of PBSC collection and continuing until 3 days before PBSCT. Patients then undergo TBI 2-3 times daily on days -8 to -5. Patients receive etoposide IV over 4 hours on day -4 and cyclophosphamide IV over 2 hours on day -2. Patients undergo PBSCT on day 0. Patients receive G-CSF SC beginning on day 0 and continuing until blood counts recover. Patients then undergo course VI as in Detailed Description.
|
Patients Who Did Not Undergo Transplant for Course V
Patients undergo courses I-IV as in Detailed Description. Beginning 3-10 days after completion of course IV, patients who are not candidates for PBSCT receive etoposide IV over 4 hours and cytarabine IV over 2 hours on days 1-4. Patients also receive G-CSF SC once or twice a day beginning on day 14 and continuing until blood counts recover. Patients then undergo course VI as in Detailed Description.
|
|---|---|---|---|---|
|
Initial Registration
Adverse Event
|
2
|
0
|
0
|
0
|
|
Initial Registration
Relapsed
|
6
|
0
|
0
|
0
|
|
Initial Registration
Received non-protocol therapy
|
11
|
0
|
0
|
0
|
|
Initial Registration
Withdrawal by Subject
|
3
|
0
|
0
|
0
|
Baseline Characteristics
Chemotherapy, Imatinib Mesylate, and Peripheral Stem Cell Transplantation in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
Baseline characteristics by cohort
| Measure |
Entire Cohort
n=57 Participants
All participants treatment on this study, see the Detailed Description for treatment information.
|
|---|---|
|
Age, Continuous
|
44 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
57 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Duration of treatment (up to 10 years)Population: One participant was excluded per study design as they did not achieve a complete remission. DFS Analysis was powered to include all patients.
Disease-free survival (DFS) was measured as the interval from achievement of complete remission (CR) until relapse or death, regardless of cause; patients alive and in CR were censored at last follow-up. DFS was estimated using the Kaplan Meier method. A complete remission (CR) was defined as recovery of morphologically normal bone marrow and blood counts (i.e., neutrophils \>= 1.5 x 10\^9/L and platelets \> 100 x 10\^9/L) and no circulating leukemic blasts or evidence of extramedullary leukemia and persisting for at least one month.
Outcome measures
| Measure |
Entire Cohort
n=56 Participants
All participants treatment on this study, see the Detailed Description for treatment information.
|
Patients Without HLA-matched Sibling Donors
Patients undergo courses I-IV as in Detailed Description. Beginning 3-10 days after completion of course IV, patients without an HLA-matched sibling donor receive etoposide IV continuously and cytarabine IV over 2 hours on days 1-4. Patients also receive G-CSF SC beginning on day 14 and continuing until PBSC collection is complete. Patients receive imatinib mesylate PO twice daily beginning after completion of PBSC collection and continuing until 3 days before PBSCT. Patients then undergo TBI 2-3 times daily on days -8 to -5. Patients receive etoposide IV over 4 hours on day -4 and cyclophosphamide IV over 2 hours on day -2. Patients undergo PBSCT on day 0. Patients receive G-CSF SC beginning on day 0 and continuing until blood counts recover. Patients then undergo course VI as in Detailed Description.
|
|---|---|---|
|
Disease Free Survival
|
1.7 years
Interval 1.1 to 4.1
|
—
|
SECONDARY outcome
Timeframe: Duration of study (up to 10 years)Population: OS Analysis was powered to include all participants.
Overall survival (OS) as the interval from the on-study date until death. OS was estimated using the Kaplan Meier method.
Outcome measures
| Measure |
Entire Cohort
n=57 Participants
All participants treatment on this study, see the Detailed Description for treatment information.
|
Patients Without HLA-matched Sibling Donors
Patients undergo courses I-IV as in Detailed Description. Beginning 3-10 days after completion of course IV, patients without an HLA-matched sibling donor receive etoposide IV continuously and cytarabine IV over 2 hours on days 1-4. Patients also receive G-CSF SC beginning on day 14 and continuing until PBSC collection is complete. Patients receive imatinib mesylate PO twice daily beginning after completion of PBSC collection and continuing until 3 days before PBSCT. Patients then undergo TBI 2-3 times daily on days -8 to -5. Patients receive etoposide IV over 4 hours on day -4 and cyclophosphamide IV over 2 hours on day -2. Patients undergo PBSCT on day 0. Patients receive G-CSF SC beginning on day 0 and continuing until blood counts recover. Patients then undergo course VI as in Detailed Description.
|
|---|---|---|
|
Overall Survival
|
3.6 years
Interval 1.9 to 6.2
|
—
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Peripheral blood stem cells were assayed from 13 patients.
BCR-ABL response is defined in two ways: complete molecular response (CMR) and major molecular response (MMR). Complete Molecular Response is defined as a Bcr-Abl (a fusion of gene of Bcr and ABl genes) ratio ≤0.0032% on the International Scale Bcr = breakpoint cluster gene Abl = abelson proto-oncogene MMR is defined as Bcr-Abl (A fusion gene of the breakpoint cluster region \[Bcr\] gene and Abelson proto-oncogene \[Abl\] genes) transcript ratio ≤0.1% (≥ 3 log reduction of BCR-ABL transcripts from a standardized baseline), as detected by reverse transcriptase polymerase chain reaction \[RT-PCR\] (performed centrally).
Outcome measures
| Measure |
Entire Cohort
n=13 Participants
All participants treatment on this study, see the Detailed Description for treatment information.
|
Patients Without HLA-matched Sibling Donors
Patients undergo courses I-IV as in Detailed Description. Beginning 3-10 days after completion of course IV, patients without an HLA-matched sibling donor receive etoposide IV continuously and cytarabine IV over 2 hours on days 1-4. Patients also receive G-CSF SC beginning on day 14 and continuing until PBSC collection is complete. Patients receive imatinib mesylate PO twice daily beginning after completion of PBSC collection and continuing until 3 days before PBSCT. Patients then undergo TBI 2-3 times daily on days -8 to -5. Patients receive etoposide IV over 4 hours on day -4 and cyclophosphamide IV over 2 hours on day -2. Patients undergo PBSCT on day 0. Patients receive G-CSF SC beginning on day 0 and continuing until blood counts recover. Patients then undergo course VI as in Detailed Description.
|
|---|---|---|
|
Number of Participants Who Achieved a BCR-ABL Response at 12 Months
Complete Molecular Response
|
9 participants
|
—
|
|
Number of Participants Who Achieved a BCR-ABL Response at 12 Months
Major Molecular Response
|
4 participants
|
—
|
SECONDARY outcome
Timeframe: 5 years from CRPopulation: Participants who received autologous or allogeneic transplants were analyzed (N=34)
Percentage of patients who achieved a complete remission (CR) and were alive and relapse free at 5 years. The 5-year progression free survival was estimated using the Kaplan Meier method.
Outcome measures
| Measure |
Entire Cohort
n=15 Participants
All participants treatment on this study, see the Detailed Description for treatment information.
|
Patients Without HLA-matched Sibling Donors
n=19 Participants
Patients undergo courses I-IV as in Detailed Description. Beginning 3-10 days after completion of course IV, patients without an HLA-matched sibling donor receive etoposide IV continuously and cytarabine IV over 2 hours on days 1-4. Patients also receive G-CSF SC beginning on day 14 and continuing until PBSC collection is complete. Patients receive imatinib mesylate PO twice daily beginning after completion of PBSC collection and continuing until 3 days before PBSCT. Patients then undergo TBI 2-3 times daily on days -8 to -5. Patients receive etoposide IV over 4 hours on day -4 and cyclophosphamide IV over 2 hours on day -2. Patients undergo PBSCT on day 0. Patients receive G-CSF SC beginning on day 0 and continuing until blood counts recover. Patients then undergo course VI as in Detailed Description.
|
|---|---|---|
|
5 Year Disease-free Survival for Autologous & Allogeneic Transplant Groups
|
46 percentage of patients
Interval 26.0 to 80.0
|
47 percentage of patients
Interval 29.0 to 76.0
|
SECONDARY outcome
Timeframe: 5 years from registrationPopulation: Participants who were on autologous or allogeneic transplant arms were analyzed (N=34).
Percentage of patients who were alive at 5 years. The 5-year progression free survival was estimated using the Kaplan Meier method.
Outcome measures
| Measure |
Entire Cohort
n=15 Participants
All participants treatment on this study, see the Detailed Description for treatment information.
|
Patients Without HLA-matched Sibling Donors
n=19 Participants
Patients undergo courses I-IV as in Detailed Description. Beginning 3-10 days after completion of course IV, patients without an HLA-matched sibling donor receive etoposide IV continuously and cytarabine IV over 2 hours on days 1-4. Patients also receive G-CSF SC beginning on day 14 and continuing until PBSC collection is complete. Patients receive imatinib mesylate PO twice daily beginning after completion of PBSC collection and continuing until 3 days before PBSCT. Patients then undergo TBI 2-3 times daily on days -8 to -5. Patients receive etoposide IV over 4 hours on day -4 and cyclophosphamide IV over 2 hours on day -2. Patients undergo PBSCT on day 0. Patients receive G-CSF SC beginning on day 0 and continuing until blood counts recover. Patients then undergo course VI as in Detailed Description.
|
|---|---|---|
|
5 Year Overall Survival for Autologous & Allogeneic Transplant Groups
|
53 percentage of patients
Interval 32.0 to 86.0
|
51 percentage of patients
Interval 32.0 to 80.0
|
Adverse Events
Patients With HLA-matched Sibling Donor
Serious events: 6 serious events
Other events: 15 other events
Deaths: 0 deaths
Patients Without HLA-matched Sibling Donors
Serious events: 9 serious events
Other events: 19 other events
Deaths: 0 deaths
Patients Who Did Not Undergo Transplant
Serious events: 3 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Patients With HLA-matched Sibling Donor
n=15 participants at risk
Patients undergo courses I-IV as in Detailed Description. Beginning 3-10 days after completion of course IV, patients with an HLA-matched sibling donor undergo total body irradiation (TBI) 2-3 times daily on days -7 to -4. Patients receive etoposide IV over 4 hours on day -3. Patients then undergo PBSCT on day 0. Patients then receive graft-vs-host disease prophylaxis with tacrolimus IV continuously on days -1 to 56 (or IV continuously on days -1 to 14 and then PO or IV every 12 hours on days 15-56) followed by a taper. Patients also receive methotrexate IV on days 1, 3, and 6, and filgrastim (G-CSF) subcutaneously (SC) beginning on day 4 and continuing until blood counts recover. Patients then undergo course VI as in Detailed Description.
|
Patients Without HLA-matched Sibling Donors
n=19 participants at risk
Patients undergo courses I-IV as in Detailed Description. Beginning 3-10 days after completion of course IV, patients without an HLA-matched sibling donor receive etoposide IV continuously and cytarabine IV over 2 hours on days 1-4. Patients also receive G-CSF SC beginning on day 14 and continuing until PBSC collection is complete. Patients receive imatinib mesylate PO twice daily beginning after completion of PBSC collection and continuing until 3 days before PBSCT. Patients then undergo TBI 2-3 times daily on days -8 to -5. Patients receive etoposide IV over 4 hours on day -4 and cyclophosphamide IV over 2 hours on day -2. Patients undergo PBSCT on day 0. Patients receive G-CSF SC beginning on day 0 and continuing until blood counts recover. Patients then undergo course VI as in Detailed Description.
|
Patients Who Did Not Undergo Transplant
n=23 participants at risk
Patients undergo courses I-IV as in Detailed Description. Beginning 3-10 days after completion of course IV, patients who are not candidates for PBSCT receive etoposide IV over 4 hours and cytarabine IV over 2 hours on days 1-4. Patients also receive G-CSF SC once or twice a day beginning on day 14 and continuing until blood counts recover. Patients then undergo course VI as in Detailed Description.
|
|---|---|---|---|
|
Gastrointestinal disorders
Anal hemorrhage
|
0.00%
0/15
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/15
|
5.3%
1/19 • Number of events 1
|
4.3%
1/23 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
3/15 • Number of events 3
|
26.3%
5/19 • Number of events 5
|
8.7%
2/23 • Number of events 2
|
|
Gastrointestinal disorders
Dry mouth
|
6.7%
1/15 • Number of events 1
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Cardiac disorders
Sinus tachycardia
|
13.3%
2/15 • Number of events 2
|
10.5%
2/19 • Number of events 2
|
0.00%
0/23
|
|
Cardiac disorders
Ventricular arrhythmia
|
13.3%
2/15 • Number of events 2
|
0.00%
0/19
|
4.3%
1/23 • Number of events 1
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/15
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Eye disorders
Diplopia
|
6.7%
1/15 • Number of events 2
|
0.00%
0/19
|
0.00%
0/23
|
|
Eye disorders
Dry eye syndrome
|
6.7%
1/15 • Number of events 1
|
0.00%
0/19
|
0.00%
0/23
|
|
Eye disorders
Eye disorder
|
13.3%
2/15 • Number of events 3
|
0.00%
0/19
|
0.00%
0/23
|
|
Eye disorders
Vision blurred
|
6.7%
1/15 • Number of events 1
|
0.00%
0/19
|
0.00%
0/23
|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
1/15 • Number of events 1
|
0.00%
0/19
|
4.3%
1/23 • Number of events 1
|
|
Cardiac disorders
Pericardial effusion
|
6.7%
1/15 • Number of events 1
|
0.00%
0/19
|
0.00%
0/23
|
|
Cardiac disorders
Edema
|
13.3%
2/15 • Number of events 3
|
10.5%
2/19 • Number of events 2
|
0.00%
0/23
|
|
Cardiac disorders
Left ventricular failure
|
6.7%
1/15 • Number of events 2
|
0.00%
0/19
|
4.3%
1/23 • Number of events 1
|
|
Cardiac disorders
Palpitations
|
0.00%
0/15
|
0.00%
0/19
|
4.3%
1/23 • Number of events 1
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.7%
1/15 • Number of events 1
|
10.5%
2/19 • Number of events 3
|
0.00%
0/23
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
26.7%
4/15 • Number of events 8
|
42.1%
8/19 • Number of events 10
|
13.0%
3/23 • Number of events 5
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/15
|
0.00%
0/19
|
4.3%
1/23 • Number of events 1
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.00%
0/15
|
5.3%
1/19 • Number of events 1
|
4.3%
1/23 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/15
|
0.00%
0/19
|
4.3%
1/23 • Number of events 1
|
|
Cardiac disorders
Cardiac disorder
|
6.7%
1/15 • Number of events 1
|
0.00%
0/19
|
8.7%
2/23 • Number of events 2
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/15
|
0.00%
0/19
|
4.3%
1/23 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/15
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
6.7%
1/15 • Number of events 1
|
0.00%
0/19
|
0.00%
0/23
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/15
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Gastrointestinal disorders
Mucositis due to radiation
|
6.7%
1/15 • Number of events 1
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Gastrointestinal disorders
Mucositis oral
|
13.3%
2/15 • Number of events 3
|
21.1%
4/19 • Number of events 5
|
0.00%
0/23
|
|
Gastrointestinal disorders
Nausea
|
33.3%
5/15 • Number of events 8
|
36.8%
7/19 • Number of events 8
|
13.0%
3/23 • Number of events 4
|
|
Gastrointestinal disorders
Typhlitis
|
0.00%
0/15
|
10.5%
2/19 • Number of events 2
|
0.00%
0/23
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
3/15 • Number of events 3
|
31.6%
6/19 • Number of events 6
|
4.3%
1/23 • Number of events 1
|
|
General disorders
Chest pain
|
0.00%
0/15
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
General disorders
Chills
|
6.7%
1/15 • Number of events 1
|
0.00%
0/19
|
4.3%
1/23 • Number of events 1
|
|
General disorders
Edema limbs
|
0.00%
0/15
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
General disorders
Fatigue
|
26.7%
4/15 • Number of events 5
|
36.8%
7/19 • Number of events 7
|
8.7%
2/23 • Number of events 2
|
|
General disorders
Fever
|
6.7%
1/15 • Number of events 1
|
0.00%
0/19
|
8.7%
2/23 • Number of events 2
|
|
General disorders
Pain
|
6.7%
1/15 • Number of events 1
|
21.1%
4/19 • Number of events 4
|
8.7%
2/23 • Number of events 2
|
|
Infections and infestations
Infection
|
0.00%
0/15
|
5.3%
1/19 • Number of events 1
|
4.3%
1/23 • Number of events 1
|
|
Infections and infestations
Infection with grade 3 or 4 neutropenia
|
13.3%
2/15 • Number of events 2
|
26.3%
5/19 • Number of events 5
|
0.00%
0/23
|
|
Infections and infestations
Infection without neutropenia
|
13.3%
2/15 • Number of events 2
|
15.8%
3/19 • Number of events 3
|
13.0%
3/23 • Number of events 3
|
|
Infections and infestations
Sepsis
|
0.00%
0/15
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/15
|
5.3%
1/19 • Number of events 1
|
4.3%
1/23 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
26.7%
4/15 • Number of events 6
|
36.8%
7/19 • Number of events 7
|
4.3%
1/23 • Number of events 2
|
|
Investigations
Alkaline phosphatase
|
0.00%
0/15
|
5.3%
1/19 • Number of events 1
|
4.3%
1/23 • Number of events 1
|
|
Investigations
Alkaline phosphatase increased
|
6.7%
1/15 • Number of events 2
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Investigations
Aspartate aminotransferase increased
|
26.7%
4/15 • Number of events 6
|
26.3%
5/19 • Number of events 5
|
4.3%
1/23 • Number of events 2
|
|
Investigations
Blood bilirubin increased
|
13.3%
2/15 • Number of events 2
|
15.8%
3/19 • Number of events 3
|
0.00%
0/23
|
|
Investigations
Creatinine increased
|
20.0%
3/15 • Number of events 5
|
10.5%
2/19 • Number of events 3
|
0.00%
0/23
|
|
Investigations
Electrocardiogram QTc interval prolonged
|
0.00%
0/15
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Investigations
INR increased
|
13.3%
2/15 • Number of events 3
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Investigations
Leukocyte count decreased
|
6.7%
1/15 • Number of events 1
|
0.00%
0/19
|
4.3%
1/23 • Number of events 1
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/15
|
0.00%
0/19
|
4.3%
1/23 • Number of events 1
|
|
Investigations
Neutrophil count decreased
|
26.7%
4/15 • Number of events 5
|
36.8%
7/19 • Number of events 8
|
8.7%
2/23 • Number of events 3
|
|
Investigations
Platelet count decreased
|
33.3%
5/15 • Number of events 9
|
42.1%
8/19 • Number of events 10
|
4.3%
1/23 • Number of events 2
|
|
Investigations
Weight loss
|
13.3%
2/15 • Number of events 3
|
0.00%
0/19
|
0.00%
0/23
|
|
Metabolism and nutrition disorders
Acidosis
|
6.7%
1/15 • Number of events 1
|
0.00%
0/19
|
0.00%
0/23
|
|
Metabolism and nutrition disorders
Alkalosis
|
6.7%
1/15 • Number of events 1
|
0.00%
0/19
|
0.00%
0/23
|
|
Metabolism and nutrition disorders
Anorexia
|
13.3%
2/15 • Number of events 3
|
10.5%
2/19 • Number of events 2
|
4.3%
1/23 • Number of events 1
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
33.3%
5/15 • Number of events 8
|
21.1%
4/19 • Number of events 4
|
8.7%
2/23 • Number of events 4
|
|
Metabolism and nutrition disorders
Blood uric acid increased
|
13.3%
2/15 • Number of events 2
|
0.00%
0/19
|
0.00%
0/23
|
|
Metabolism and nutrition disorders
Dehydration
|
6.7%
1/15 • Number of events 2
|
0.00%
0/19
|
0.00%
0/23
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
13.3%
2/15 • Number of events 3
|
10.5%
2/19 • Number of events 2
|
4.3%
1/23 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
26.7%
4/15 • Number of events 6
|
15.8%
3/19 • Number of events 3
|
8.7%
2/23 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum calcium increased
|
6.7%
1/15 • Number of events 1
|
0.00%
0/19
|
0.00%
0/23
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
0.00%
0/15
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
6.7%
1/15 • Number of events 1
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Metabolism and nutrition disorders
Serum magnesium increased
|
6.7%
1/15 • Number of events 2
|
0.00%
0/19
|
0.00%
0/23
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
13.3%
2/15 • Number of events 3
|
10.5%
2/19 • Number of events 2
|
0.00%
0/23
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
20.0%
3/15 • Number of events 4
|
15.8%
3/19 • Number of events 4
|
8.7%
2/23 • Number of events 3
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
6.7%
1/15 • Number of events 2
|
0.00%
0/19
|
0.00%
0/23
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
13.3%
2/15 • Number of events 3
|
10.5%
2/19 • Number of events 2
|
4.3%
1/23 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum sodium increased
|
6.7%
1/15 • Number of events 1
|
0.00%
0/19
|
0.00%
0/23
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
6.7%
1/15 • Number of events 1
|
0.00%
0/19
|
0.00%
0/23
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
0.00%
0/15
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
0.00%
0/15
|
0.00%
0/19
|
4.3%
1/23 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/15
|
15.8%
3/19 • Number of events 3
|
4.3%
1/23 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/15
|
5.3%
1/19 • Number of events 1
|
4.3%
1/23 • Number of events 1
|
|
Nervous system disorders
Ataxia
|
6.7%
1/15 • Number of events 1
|
0.00%
0/19
|
0.00%
0/23
|
|
Nervous system disorders
Depressed level of consciousness
|
6.7%
1/15 • Number of events 1
|
0.00%
0/19
|
0.00%
0/23
|
|
Nervous system disorders
Dizziness
|
6.7%
1/15 • Number of events 1
|
10.5%
2/19 • Number of events 2
|
4.3%
1/23 • Number of events 1
|
|
Nervous system disorders
Headache
|
13.3%
2/15 • Number of events 2
|
0.00%
0/19
|
4.3%
1/23 • Number of events 1
|
|
Nervous system disorders
Memory impairment
|
6.7%
1/15 • Number of events 1
|
0.00%
0/19
|
4.3%
1/23 • Number of events 1
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/15
|
5.3%
1/19 • Number of events 1
|
8.7%
2/23 • Number of events 2
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
13.3%
2/15 • Number of events 2
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Nervous system disorders
Seizure
|
0.00%
0/15
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Nervous system disorders
Syncope
|
0.00%
0/15
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Nervous system disorders
Tremor
|
13.3%
2/15 • Number of events 2
|
0.00%
0/19
|
0.00%
0/23
|
|
Psychiatric disorders
Anxiety
|
6.7%
1/15 • Number of events 2
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Psychiatric disorders
Confusion
|
6.7%
1/15 • Number of events 1
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Psychiatric disorders
Depression
|
13.3%
2/15 • Number of events 2
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Psychiatric disorders
Insomnia
|
6.7%
1/15 • Number of events 1
|
0.00%
0/19
|
0.00%
0/23
|
|
Renal and urinary disorders
Dysuria (painful urination)
|
0.00%
0/15
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Renal and urinary disorders
Hematuria (in the absence of vaginal bleeding)
|
0.00%
0/15
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/15
|
0.00%
0/19
|
4.3%
1/23 • Number of events 1
|
|
Renal and urinary disorders
Urogenital disorder
|
13.3%
2/15 • Number of events 2
|
0.00%
0/19
|
0.00%
0/23
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
0.00%
0/15
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
13.3%
2/15 • Number of events 3
|
0.00%
0/19
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
6.7%
1/15 • Number of events 2
|
0.00%
0/19
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
3/15 • Number of events 4
|
5.3%
1/19 • Number of events 1
|
8.7%
2/23 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
3/15 • Number of events 3
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
26.7%
4/15 • Number of events 5
|
5.3%
1/19 • Number of events 1
|
13.0%
3/23 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/15
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/15
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.7%
1/15 • Number of events 1
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.7%
1/15 • Number of events 1
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
13.3%
2/15 • Number of events 3
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
6.7%
1/15 • Number of events 1
|
0.00%
0/19
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
6.7%
1/15 • Number of events 1
|
0.00%
0/19
|
0.00%
0/23
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/15
|
5.3%
1/19 • Number of events 1
|
4.3%
1/23 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/15
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/15
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
13.3%
2/15 • Number of events 2
|
0.00%
0/19
|
0.00%
0/23
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
26.7%
4/15 • Number of events 4
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
6.7%
1/15 • Number of events 1
|
0.00%
0/19
|
0.00%
0/23
|
|
Vascular disorders
Flushing
|
6.7%
1/15 • Number of events 1
|
0.00%
0/19
|
0.00%
0/23
|
|
Vascular disorders
Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia
|
0.00%
0/15
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Vascular disorders
Hot flashes
|
0.00%
0/15
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Vascular disorders
Hypotension
|
20.0%
3/15 • Number of events 3
|
21.1%
4/19 • Number of events 4
|
4.3%
1/23 • Number of events 1
|
|
Vascular disorders
Thrombosis
|
6.7%
1/15 • Number of events 1
|
15.8%
3/19 • Number of events 3
|
0.00%
0/23
|
Other adverse events
| Measure |
Patients With HLA-matched Sibling Donor
n=15 participants at risk
Patients undergo courses I-IV as in Detailed Description. Beginning 3-10 days after completion of course IV, patients with an HLA-matched sibling donor undergo total body irradiation (TBI) 2-3 times daily on days -7 to -4. Patients receive etoposide IV over 4 hours on day -3. Patients then undergo PBSCT on day 0. Patients then receive graft-vs-host disease prophylaxis with tacrolimus IV continuously on days -1 to 56 (or IV continuously on days -1 to 14 and then PO or IV every 12 hours on days 15-56) followed by a taper. Patients also receive methotrexate IV on days 1, 3, and 6, and filgrastim (G-CSF) subcutaneously (SC) beginning on day 4 and continuing until blood counts recover. Patients then undergo course VI as in Detailed Description.
|
Patients Without HLA-matched Sibling Donors
n=19 participants at risk
Patients undergo courses I-IV as in Detailed Description. Beginning 3-10 days after completion of course IV, patients without an HLA-matched sibling donor receive etoposide IV continuously and cytarabine IV over 2 hours on days 1-4. Patients also receive G-CSF SC beginning on day 14 and continuing until PBSC collection is complete. Patients receive imatinib mesylate PO twice daily beginning after completion of PBSC collection and continuing until 3 days before PBSCT. Patients then undergo TBI 2-3 times daily on days -8 to -5. Patients receive etoposide IV over 4 hours on day -4 and cyclophosphamide IV over 2 hours on day -2. Patients undergo PBSCT on day 0. Patients receive G-CSF SC beginning on day 0 and continuing until blood counts recover. Patients then undergo course VI as in Detailed Description.
|
Patients Who Did Not Undergo Transplant
n=23 participants at risk
Patients undergo courses I-IV as in Detailed Description. Beginning 3-10 days after completion of course IV, patients who are not candidates for PBSCT receive etoposide IV over 4 hours and cytarabine IV over 2 hours on days 1-4. Patients also receive G-CSF SC once or twice a day beginning on day 14 and continuing until blood counts recover. Patients then undergo course VI as in Detailed Description.
|
|---|---|---|---|
|
Vascular disorders
Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia
|
13.3%
2/15 • Number of events 2
|
10.5%
2/19 • Number of events 2
|
0.00%
0/23
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/15
|
10.5%
2/19 • Number of events 2
|
0.00%
0/23
|
|
Blood and lymphatic system disorders
Blood disorder
|
0.00%
0/15
|
0.00%
0/19
|
4.3%
1/23 • Number of events 1
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
26.7%
4/15 • Number of events 4
|
52.6%
10/19 • Number of events 10
|
4.3%
1/23 • Number of events 1
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
93.3%
14/15 • Number of events 70
|
100.0%
19/19 • Number of events 149
|
82.6%
19/23 • Number of events 53
|
|
Blood and lymphatic system disorders
Lymphatic disorder
|
6.7%
1/15 • Number of events 1
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Blood and lymphatic system disorders
Transfusion: Platelets
|
6.7%
1/15 • Number of events 1
|
10.5%
2/19 • Number of events 2
|
0.00%
0/23
|
|
Blood and lymphatic system disorders
Transfusion: pRBCs
|
6.7%
1/15 • Number of events 2
|
10.5%
2/19 • Number of events 3
|
0.00%
0/23
|
|
Cardiac disorders
Arrhythmia
|
6.7%
1/15 • Number of events 1
|
10.5%
2/19 • Number of events 3
|
0.00%
0/23
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.00%
0/15
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/15
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Cardiac disorders
Cardiac disorder
|
6.7%
1/15 • Number of events 1
|
0.00%
0/19
|
4.3%
1/23 • Number of events 4
|
|
Cardiac disorders
Cardiac pain
|
0.00%
0/15
|
10.5%
2/19 • Number of events 2
|
0.00%
0/23
|
|
Cardiac disorders
Edema
|
60.0%
9/15 • Number of events 24
|
52.6%
10/19 • Number of events 25
|
39.1%
9/23 • Number of events 13
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/15
|
5.3%
1/19 • Number of events 1
|
4.3%
1/23 • Number of events 1
|
|
Cardiac disorders
Myocardial ischemia
|
0.00%
0/15
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Cardiac disorders
Nodal arrhythmia
|
0.00%
0/15
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Cardiac disorders
Palpitations
|
20.0%
3/15 • Number of events 4
|
15.8%
3/19 • Number of events 3
|
4.3%
1/23 • Number of events 1
|
|
Cardiac disorders
Sinus arrhythmia
|
6.7%
1/15 • Number of events 1
|
0.00%
0/19
|
0.00%
0/23
|
|
Cardiac disorders
Sinus tachycardia
|
26.7%
4/15 • Number of events 4
|
21.1%
4/19 • Number of events 11
|
0.00%
0/23
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/15
|
0.00%
0/19
|
4.3%
1/23 • Number of events 1
|
|
Ear and labyrinth disorders
Ear disorder
|
6.7%
1/15 • Number of events 3
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Ear and labyrinth disorders
Hearing impaired
|
6.7%
1/15 • Number of events 1
|
0.00%
0/19
|
0.00%
0/23
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
0.00%
0/15
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/15
|
5.3%
1/19 • Number of events 2
|
0.00%
0/23
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/15
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Endocrine disorders
Cushingoid
|
0.00%
0/15
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Eye disorders
Dry eye syndrome
|
20.0%
3/15 • Number of events 19
|
10.5%
2/19 • Number of events 2
|
0.00%
0/23
|
|
Eye disorders
Eye disorder
|
20.0%
3/15 • Number of events 3
|
10.5%
2/19 • Number of events 2
|
4.3%
1/23 • Number of events 1
|
|
Eye disorders
Flashing vision
|
0.00%
0/15
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Eye disorders
Photophobia
|
0.00%
0/15
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Eye disorders
Vision blurred
|
13.3%
2/15 • Number of events 3
|
5.3%
1/19 • Number of events 1
|
4.3%
1/23 • Number of events 1
|
|
Eye disorders
Watering eyes
|
6.7%
1/15 • Number of events 1
|
0.00%
0/19
|
4.3%
1/23 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal distension
|
6.7%
1/15 • Number of events 1
|
0.00%
0/19
|
0.00%
0/23
|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
3/15 • Number of events 4
|
31.6%
6/19 • Number of events 12
|
8.7%
2/23 • Number of events 2
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/15
|
10.5%
2/19 • Number of events 2
|
0.00%
0/23
|
|
Gastrointestinal disorders
Constipation
|
13.3%
2/15 • Number of events 3
|
52.6%
10/19 • Number of events 14
|
8.7%
2/23 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
80.0%
12/15 • Number of events 30
|
68.4%
13/19 • Number of events 42
|
39.1%
9/23 • Number of events 15
|
|
Gastrointestinal disorders
Dry mouth
|
33.3%
5/15 • Number of events 13
|
0.00%
0/19
|
0.00%
0/23
|
|
Gastrointestinal disorders
Dyspepsia
|
26.7%
4/15 • Number of events 9
|
15.8%
3/19 • Number of events 3
|
4.3%
1/23 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia
|
6.7%
1/15 • Number of events 1
|
21.1%
4/19 • Number of events 4
|
0.00%
0/23
|
|
Gastrointestinal disorders
Esophagitis
|
13.3%
2/15 • Number of events 2
|
21.1%
4/19 • Number of events 4
|
4.3%
1/23 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/15
|
21.1%
4/19 • Number of events 6
|
8.7%
2/23 • Number of events 3
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
26.7%
4/15 • Number of events 7
|
15.8%
3/19 • Number of events 3
|
0.00%
0/23
|
|
Gastrointestinal disorders
Hemorrhoids
|
6.7%
1/15 • Number of events 1
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
6.7%
1/15 • Number of events 2
|
0.00%
0/19
|
0.00%
0/23
|
|
Gastrointestinal disorders
Mucositis due to radiation
|
0.00%
0/15
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Gastrointestinal disorders
Mucositis oral
|
93.3%
14/15 • Number of events 19
|
68.4%
13/19 • Number of events 16
|
8.7%
2/23 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
86.7%
13/15 • Number of events 39
|
94.7%
18/19 • Number of events 80
|
60.9%
14/23 • Number of events 28
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/15
|
0.00%
0/19
|
4.3%
1/23 • Number of events 1
|
|
Gastrointestinal disorders
Rectal pain
|
0.00%
0/15
|
10.5%
2/19 • Number of events 2
|
0.00%
0/23
|
|
Gastrointestinal disorders
Stomatitis/pharyngitis (oral/pharyngeal mucositis) for BMT studies, if specified in
|
6.7%
1/15 • Number of events 1
|
0.00%
0/19
|
0.00%
0/23
|
|
Gastrointestinal disorders
Tooth disorder
|
0.00%
0/15
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Gastrointestinal disorders
Vomiting
|
80.0%
12/15 • Number of events 23
|
78.9%
15/19 • Number of events 48
|
47.8%
11/23 • Number of events 17
|
|
General disorders
Chest pain
|
0.00%
0/15
|
15.8%
3/19 • Number of events 5
|
4.3%
1/23 • Number of events 1
|
|
General disorders
Chills
|
13.3%
2/15 • Number of events 5
|
31.6%
6/19 • Number of events 8
|
8.7%
2/23 • Number of events 2
|
|
General disorders
Edema limbs
|
0.00%
0/15
|
21.1%
4/19 • Number of events 7
|
4.3%
1/23 • Number of events 2
|
|
General disorders
Fatigue
|
73.3%
11/15 • Number of events 43
|
89.5%
17/19 • Number of events 77
|
52.2%
12/23 • Number of events 26
|
|
General disorders
Fever
|
33.3%
5/15 • Number of events 5
|
31.6%
6/19 • Number of events 12
|
21.7%
5/23 • Number of events 6
|
|
General disorders
Ill-defined disorder
|
6.7%
1/15 • Number of events 2
|
0.00%
0/19
|
0.00%
0/23
|
|
General disorders
Localized edema
|
0.00%
0/15
|
5.3%
1/19 • Number of events 4
|
0.00%
0/23
|
|
General disorders
Pain
|
26.7%
4/15 • Number of events 7
|
36.8%
7/19 • Number of events 19
|
21.7%
5/23 • Number of events 5
|
|
Infections and infestations
Bladder infection
|
0.00%
0/15
|
5.3%
1/19 • Number of events 2
|
0.00%
0/23
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/15
|
15.8%
3/19 • Number of events 3
|
0.00%
0/23
|
|
Infections and infestations
Colitis, infectious (e.g., Clostridium difficile)
|
0.00%
0/15
|
0.00%
0/19
|
4.3%
1/23 • Number of events 1
|
|
Infections and infestations
Gingival infection
|
0.00%
0/15
|
5.3%
1/19 • Number of events 1
|
4.3%
1/23 • Number of events 1
|
|
Infections and infestations
Infection
|
13.3%
2/15 • Number of events 2
|
21.1%
4/19 • Number of events 5
|
13.0%
3/23 • Number of events 4
|
|
Infections and infestations
Infection with grade 3 or 4 neutropenia
|
40.0%
6/15 • Number of events 8
|
42.1%
8/19 • Number of events 11
|
4.3%
1/23 • Number of events 1
|
|
Infections and infestations
Infection without neutropenia
|
40.0%
6/15 • Number of events 10
|
57.9%
11/19 • Number of events 19
|
17.4%
4/23 • Number of events 5
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/15
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Infections and infestations
Pneumonia
|
6.7%
1/15 • Number of events 1
|
5.3%
1/19 • Number of events 2
|
0.00%
0/23
|
|
Infections and infestations
Sinusitis
|
0.00%
0/15
|
5.3%
1/19 • Number of events 2
|
0.00%
0/23
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/15
|
0.00%
0/19
|
4.3%
1/23 • Number of events 1
|
|
Infections and infestations
Wound-infectious
|
0.00%
0/15
|
0.00%
0/19
|
4.3%
1/23 • Number of events 1
|
|
Injury, poisoning and procedural complications
Bruising
|
6.7%
1/15 • Number of events 1
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
0.00%
0/15
|
10.5%
2/19 • Number of events 2
|
0.00%
0/23
|
|
Injury, poisoning and procedural complications
Postoperative hemorrhage
|
0.00%
0/15
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Injury, poisoning and procedural complications
Radiation recall reaction (dermatologic)
|
0.00%
0/15
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/15
|
0.00%
0/19
|
4.3%
1/23 • Number of events 1
|
|
Investigations
Activated partial thromboplastin time prolonged
|
26.7%
4/15 • Number of events 4
|
42.1%
8/19 • Number of events 13
|
0.00%
0/23
|
|
Investigations
Alanine aminotransferase increased
|
66.7%
10/15 • Number of events 26
|
63.2%
12/19 • Number of events 36
|
30.4%
7/23 • Number of events 11
|
|
Investigations
Alkaline phosphatase
|
26.7%
4/15 • Number of events 6
|
21.1%
4/19 • Number of events 6
|
8.7%
2/23 • Number of events 3
|
|
Investigations
Alkaline phosphatase increased
|
6.7%
1/15 • Number of events 1
|
21.1%
4/19 • Number of events 4
|
17.4%
4/23 • Number of events 6
|
|
Investigations
Amylase increased
|
6.7%
1/15 • Number of events 1
|
0.00%
0/19
|
0.00%
0/23
|
|
Investigations
Aspartate aminotransferase increased
|
73.3%
11/15 • Number of events 22
|
78.9%
15/19 • Number of events 44
|
39.1%
9/23 • Number of events 12
|
|
Investigations
Blood bilirubin increased
|
40.0%
6/15 • Number of events 11
|
42.1%
8/19 • Number of events 11
|
8.7%
2/23 • Number of events 2
|
|
Investigations
Coagulopathy
|
6.7%
1/15 • Number of events 1
|
0.00%
0/19
|
0.00%
0/23
|
|
Investigations
Creatine phosphokinase increased
|
0.00%
0/15
|
0.00%
0/19
|
4.3%
1/23 • Number of events 2
|
|
Investigations
Creatinine increased
|
46.7%
7/15 • Number of events 14
|
42.1%
8/19 • Number of events 35
|
17.4%
4/23 • Number of events 5
|
|
Investigations
Electrocardiogram QTc interval prolonged
|
0.00%
0/15
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Investigations
Gamma-glutamyltransferase increased
|
6.7%
1/15 • Number of events 4
|
0.00%
0/19
|
0.00%
0/23
|
|
Investigations
INR increased
|
20.0%
3/15 • Number of events 3
|
15.8%
3/19 • Number of events 5
|
4.3%
1/23 • Number of events 2
|
|
Investigations
Laboratory test abnormal
|
6.7%
1/15 • Number of events 1
|
0.00%
0/19
|
8.7%
2/23 • Number of events 2
|
|
Investigations
Leukocyte count decreased
|
46.7%
7/15 • Number of events 26
|
21.1%
4/19 • Number of events 28
|
39.1%
9/23 • Number of events 14
|
|
Investigations
Leukocytes (total WBC) for BMT studies, if specified in the protocol.
|
0.00%
0/15
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Investigations
Lymphocyte count decreased
|
20.0%
3/15 • Number of events 8
|
15.8%
3/19 • Number of events 16
|
34.8%
8/23 • Number of events 14
|
|
Investigations
Neutrophil count decreased
|
86.7%
13/15 • Number of events 42
|
89.5%
17/19 • Number of events 72
|
30.4%
7/23 • Number of events 20
|
|
Investigations
Platelet count decreased
|
80.0%
12/15 • Number of events 43
|
100.0%
19/19 • Number of events 97
|
39.1%
9/23 • Number of events 14
|
|
Investigations
Weight gain
|
33.3%
5/15 • Number of events 5
|
5.3%
1/19 • Number of events 3
|
4.3%
1/23 • Number of events 1
|
|
Investigations
Weight loss
|
20.0%
3/15 • Number of events 3
|
10.5%
2/19 • Number of events 2
|
4.3%
1/23 • Number of events 1
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/15
|
0.00%
0/19
|
4.3%
1/23 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
60.0%
9/15 • Number of events 15
|
68.4%
13/19 • Number of events 27
|
21.7%
5/23 • Number of events 5
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
60.0%
9/15 • Number of events 40
|
84.2%
16/19 • Number of events 62
|
52.2%
12/23 • Number of events 22
|
|
Metabolism and nutrition disorders
Blood uric acid increased
|
0.00%
0/15
|
15.8%
3/19 • Number of events 3
|
0.00%
0/23
|
|
Metabolism and nutrition disorders
Dehydration
|
6.7%
1/15 • Number of events 1
|
10.5%
2/19 • Number of events 3
|
0.00%
0/23
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
33.3%
5/15 • Number of events 9
|
42.1%
8/19 • Number of events 20
|
21.7%
5/23 • Number of events 8
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
53.3%
8/15 • Number of events 20
|
52.6%
10/19 • Number of events 23
|
39.1%
9/23 • Number of events 12
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
13.3%
2/15 • Number of events 2
|
31.6%
6/19 • Number of events 9
|
0.00%
0/23
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
53.3%
8/15 • Number of events 16
|
42.1%
8/19 • Number of events 16
|
4.3%
1/23 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum magnesium increased
|
6.7%
1/15 • Number of events 1
|
15.8%
3/19 • Number of events 3
|
0.00%
0/23
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
26.7%
4/15 • Number of events 9
|
31.6%
6/19 • Number of events 9
|
13.0%
3/23 • Number of events 3
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
53.3%
8/15 • Number of events 17
|
73.7%
14/19 • Number of events 49
|
39.1%
9/23 • Number of events 14
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
6.7%
1/15 • Number of events 2
|
15.8%
3/19 • Number of events 4
|
0.00%
0/23
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
26.7%
4/15 • Number of events 11
|
26.3%
5/19 • Number of events 10
|
17.4%
4/23 • Number of events 5
|
|
Metabolism and nutrition disorders
Serum sodium increased
|
6.7%
1/15 • Number of events 2
|
5.3%
1/19 • Number of events 2
|
8.7%
2/23 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
26.7%
4/15 • Number of events 7
|
31.6%
6/19 • Number of events 9
|
13.0%
3/23 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/15
|
0.00%
0/19
|
4.3%
1/23 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.3%
2/15 • Number of events 5
|
0.00%
0/19
|
13.0%
3/23 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
13.3%
2/15 • Number of events 2
|
10.5%
2/19 • Number of events 2
|
8.7%
2/23 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
0.00%
0/15
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/15
|
10.5%
2/19 • Number of events 2
|
4.3%
1/23 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Joint disorder
|
0.00%
0/15
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
20.0%
3/15 • Number of events 6
|
15.8%
3/19 • Number of events 3
|
4.3%
1/23 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
6.7%
1/15 • Number of events 1
|
5.3%
1/19 • Number of events 1
|
4.3%
1/23 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
53.3%
8/15 • Number of events 13
|
52.6%
10/19 • Number of events 23
|
21.7%
5/23 • Number of events 9
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
6.7%
1/15 • Number of events 3
|
0.00%
0/19
|
0.00%
0/23
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.7%
1/15 • Number of events 2
|
0.00%
0/19
|
0.00%
0/23
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/15
|
15.8%
3/19 • Number of events 5
|
0.00%
0/23
|
|
Nervous system disorders
Arachnoiditis
|
6.7%
1/15 • Number of events 1
|
0.00%
0/19
|
0.00%
0/23
|
|
Nervous system disorders
Ataxia
|
0.00%
0/15
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/15
|
10.5%
2/19 • Number of events 3
|
0.00%
0/23
|
|
Nervous system disorders
Dizziness
|
33.3%
5/15 • Number of events 10
|
47.4%
9/19 • Number of events 14
|
8.7%
2/23 • Number of events 2
|
|
Nervous system disorders
Dysgeusia
|
20.0%
3/15 • Number of events 7
|
5.3%
1/19 • Number of events 1
|
4.3%
1/23 • Number of events 1
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.00%
0/15
|
10.5%
2/19 • Number of events 2
|
0.00%
0/23
|
|
Nervous system disorders
Headache
|
80.0%
12/15 • Number of events 28
|
89.5%
17/19 • Number of events 40
|
52.2%
12/23 • Number of events 14
|
|
Nervous system disorders
Memory impairment
|
6.7%
1/15 • Number of events 1
|
5.3%
1/19 • Number of events 1
|
8.7%
2/23 • Number of events 2
|
|
Nervous system disorders
Neurological disorder NOS
|
6.7%
1/15 • Number of events 1
|
10.5%
2/19 • Number of events 2
|
0.00%
0/23
|
|
Nervous system disorders
Nystagmus
|
0.00%
0/15
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Nervous system disorders
Peripheral motor neuropathy
|
26.7%
4/15 • Number of events 4
|
26.3%
5/19 • Number of events 12
|
4.3%
1/23 • Number of events 1
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
60.0%
9/15 • Number of events 20
|
73.7%
14/19 • Number of events 48
|
43.5%
10/23 • Number of events 17
|
|
Nervous system disorders
Syncope
|
6.7%
1/15 • Number of events 1
|
0.00%
0/19
|
0.00%
0/23
|
|
Nervous system disorders
Tremor
|
53.3%
8/15 • Number of events 15
|
10.5%
2/19 • Number of events 3
|
0.00%
0/23
|
|
Psychiatric disorders
Agitation
|
0.00%
0/15
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Psychiatric disorders
Anxiety
|
20.0%
3/15 • Number of events 7
|
36.8%
7/19 • Number of events 11
|
13.0%
3/23 • Number of events 3
|
|
Psychiatric disorders
Confusion
|
33.3%
5/15 • Number of events 5
|
21.1%
4/19 • Number of events 4
|
8.7%
2/23 • Number of events 2
|
|
Psychiatric disorders
Depression
|
20.0%
3/15 • Number of events 6
|
36.8%
7/19 • Number of events 11
|
13.0%
3/23 • Number of events 4
|
|
Psychiatric disorders
Insomnia
|
26.7%
4/15 • Number of events 4
|
36.8%
7/19 • Number of events 10
|
13.0%
3/23 • Number of events 4
|
|
Renal and urinary disorders
Dysuria (painful urination)
|
13.3%
2/15 • Number of events 2
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Renal and urinary disorders
Hematuria (in the absence of vaginal bleeding)
|
0.00%
0/15
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Renal and urinary disorders
Hemorrhage urinary tract
|
0.00%
0/15
|
10.5%
2/19 • Number of events 2
|
0.00%
0/23
|
|
Renal and urinary disorders
Urinary frequency
|
6.7%
1/15 • Number of events 1
|
0.00%
0/19
|
0.00%
0/23
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/15
|
10.5%
2/19 • Number of events 2
|
0.00%
0/23
|
|
Renal and urinary disorders
Urine discoloration
|
6.7%
1/15 • Number of events 1
|
0.00%
0/19
|
0.00%
0/23
|
|
Renal and urinary disorders
Urogenital disorder
|
6.7%
1/15 • Number of events 1
|
0.00%
0/19
|
0.00%
0/23
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/15
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Reproductive system and breast disorders
Gynecomastia
|
0.00%
0/15
|
5.3%
1/19 • Number of events 2
|
0.00%
0/23
|
|
Reproductive system and breast disorders
Irregular menstruation
|
0.00%
0/15
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Reproductive system and breast disorders
Reproductive tract disorder
|
0.00%
0/15
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/15
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
6.7%
1/15 • Number of events 1
|
15.8%
3/19 • Number of events 3
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
20.0%
3/15 • Number of events 3
|
10.5%
2/19 • Number of events 10
|
13.0%
3/23 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
6.7%
1/15 • Number of events 1
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
46.7%
7/15 • Number of events 16
|
63.2%
12/19 • Number of events 23
|
8.7%
2/23 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
3/15 • Number of events 4
|
5.3%
1/19 • Number of events 3
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
33.3%
5/15 • Number of events 6
|
47.4%
9/19 • Number of events 12
|
4.3%
1/23 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.7%
1/15 • Number of events 1
|
31.6%
6/19 • Number of events 6
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.7%
1/15 • Number of events 1
|
0.00%
0/19
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/15
|
5.3%
1/19 • Number of events 1
|
4.3%
1/23 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.7%
1/15 • Number of events 2
|
0.00%
0/19
|
8.7%
2/23 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/15
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
6.7%
1/15 • Number of events 1
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/15
|
21.1%
4/19 • Number of events 4
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
6.7%
1/15 • Number of events 1
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
40.0%
6/15 • Number of events 10
|
26.3%
5/19 • Number of events 9
|
13.0%
3/23 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
13.3%
2/15 • Number of events 4
|
15.8%
3/19 • Number of events 3
|
4.3%
1/23 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
6.7%
1/15 • Number of events 1
|
0.00%
0/19
|
0.00%
0/23
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
13.3%
2/15 • Number of events 2
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
6.7%
1/15 • Number of events 1
|
0.00%
0/19
|
4.3%
1/23 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
13.3%
2/15 • Number of events 2
|
15.8%
3/19 • Number of events 3
|
0.00%
0/23
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
13.3%
2/15 • Number of events 2
|
0.00%
0/19
|
0.00%
0/23
|
|
Skin and subcutaneous tissue disorders
Pigmentation changes (e.g., vitiligo)
|
6.7%
1/15 • Number of events 2
|
10.5%
2/19 • Number of events 2
|
4.3%
1/23 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
13.3%
2/15 • Number of events 3
|
15.8%
3/19 • Number of events 4
|
0.00%
0/23
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
6.7%
1/15 • Number of events 3
|
0.00%
0/19
|
0.00%
0/23
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
73.3%
11/15 • Number of events 20
|
57.9%
11/19 • Number of events 16
|
21.7%
5/23 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Rash/dermatitis associated with high-dose chemotherapy or BMT studies.
|
6.7%
1/15 • Number of events 1
|
0.00%
0/19
|
0.00%
0/23
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation associated with graft versus host disease (GVHD) for BMT studies
|
13.3%
2/15 • Number of events 2
|
0.00%
0/19
|
0.00%
0/23
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
26.7%
4/15 • Number of events 4
|
15.8%
3/19 • Number of events 3
|
0.00%
0/23
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/15
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.00%
0/15
|
5.3%
1/19 • Number of events 3
|
0.00%
0/23
|
|
Skin and subcutaneous tissue disorders
Sweating
|
0.00%
0/15
|
5.3%
1/19 • Number of events 1
|
8.7%
2/23 • Number of events 2
|
|
Vascular disorders
Flushing
|
13.3%
2/15 • Number of events 2
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Vascular disorders
Hemorrhage
|
0.00%
0/15
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Vascular disorders
Hemorrhage/bleeding without grade 3 or 4 thrombocytopenia
|
13.3%
2/15 • Number of events 2
|
0.00%
0/19
|
0.00%
0/23
|
|
Vascular disorders
Hot flashes
|
0.00%
0/15
|
5.3%
1/19 • Number of events 1
|
0.00%
0/23
|
|
Vascular disorders
Hypertension
|
26.7%
4/15 • Number of events 5
|
21.1%
4/19 • Number of events 6
|
8.7%
2/23 • Number of events 2
|
|
Vascular disorders
Hypotension
|
13.3%
2/15 • Number of events 2
|
15.8%
3/19 • Number of events 6
|
8.7%
2/23 • Number of events 2
|
|
Vascular disorders
Thrombosis
|
6.7%
1/15 • Number of events 1
|
15.8%
3/19 • Number of events 5
|
0.00%
0/23
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60