Trial Outcomes & Findings for Combination Chemotherapy With or Without Donor Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia (NCT NCT00792948)

NCT ID: NCT00792948

Last Updated: 2025-11-24

Results Overview

Will be estimated using the method of Kaplan-Meier.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE2
• Target enrollment: 97 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2025-11-24

Participant Flow

Participant milestones

Measure	Treatment See Detailed Description Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant Cyclophosphamide: Given IV Cytarabine: Given IT Dasatinib: Given PO Dexamethasone: Given IV or PO Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Laboratory Biomarker Analysis: Correlative studies Leucovorin Calcium: Given IV Methotrexate: Given IV or IT Methylprednisolone: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic stem cell transplant Prednisone: Given PO Sirolimus: Given PO Tacrolimus: Given IV Total-Body Irradiation: Undergo TBI Vincristine Sulfate: Given IV
Overall Study STARTED	97
Overall Study COMPLETED	69
Overall Study NOT COMPLETED	28

Reasons for withdrawal

Measure	Treatment See Detailed Description Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant Cyclophosphamide: Given IV Cytarabine: Given IT Dasatinib: Given PO Dexamethasone: Given IV or PO Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Laboratory Biomarker Analysis: Correlative studies Leucovorin Calcium: Given IV Methotrexate: Given IV or IT Methylprednisolone: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic stem cell transplant Prednisone: Given PO Sirolimus: Given PO Tacrolimus: Given IV Total-Body Irradiation: Undergo TBI Vincristine Sulfate: Given IV
Overall Study Adverse Event	6
Overall Study Death	4
Overall Study Withdrawal by Subject	3
Overall Study Ineligible	2
Overall Study Insurance denial - not treated	1
Overall Study Physician Decision	11
Overall Study Protocol Violation	1

Baseline Characteristics

Combination Chemotherapy With or Without Donor Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia

Baseline characteristics by cohort

Measure	Treatment n=94 Participants
Age, Continuous	44 years n=45 Participants
Sex: Female, Male Female	52 Participants n=45 Participants
Sex: Female, Male Male	42 Participants n=45 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Patients who received allogeneic stem cell transplant

Will be estimated using the method of Kaplan-Meier.

Outcome measures

Measure

Treatment n=40 Participants See Detailed Description Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant Cyclophosphamide: Given IV Cytarabine: Given IT Dasatinib: Given PO Dexamethasone: Given IV or PO Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Laboratory Biomarker Analysis: Correlative studies Leucovorin Calcium: Given IV Methotrexate: Given IV or IT Methylprednisolone: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic stem cell transplant Prednisone: Given PO Sirolimus: Given PO Tacrolimus: Given IV Total-Body Irradiation: Undergo TBI Vincristine Sulfate: Given IV

Relapse-free Survival (RFS) After Allogeneic Stem Cell Transplantation

0.83 Probability of 12-month RFS Interval 0.67 to 0.91

SECONDARY outcome

Timeframe: 18 months

Population: Patients who had not received prior ALL therapy

Will be testing using an exact binomial test

Outcome measures

Measure

Treatment n=60 Participants See Detailed Description Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant Cyclophosphamide: Given IV Cytarabine: Given IT Dasatinib: Given PO Dexamethasone: Given IV or PO Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Laboratory Biomarker Analysis: Correlative studies Leucovorin Calcium: Given IV Methotrexate: Given IV or IT Methylprednisolone: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic stem cell transplant Prednisone: Given PO Sirolimus: Given PO Tacrolimus: Given IV Total-Body Irradiation: Undergo TBI Vincristine Sulfate: Given IV

Continuous Complete Remission (CCR) Rate

57 percentage of participants Interval 43.0 to 69.0

OTHER_PRE_SPECIFIED outcome

Timeframe: From the date of initial registration on the study until death from any cause, assessed up to 5 years

Population: Analysis includes eligible patients who received treatment.

OS will be estimated using the method of Kaplan-Meier.

Outcome measures

Measure

Treatment n=94 Participants See Detailed Description Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant Cyclophosphamide: Given IV Cytarabine: Given IT Dasatinib: Given PO Dexamethasone: Given IV or PO Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Laboratory Biomarker Analysis: Correlative studies Leucovorin Calcium: Given IV Methotrexate: Given IV or IT Methylprednisolone: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic stem cell transplant Prednisone: Given PO Sirolimus: Given PO Tacrolimus: Given IV Total-Body Irradiation: Undergo TBI Vincristine Sulfate: Given IV

Overall Survival (OS)

0.88 Probability of surviving 12 months Interval 0.8 to 0.93

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 5 years

Correlation between the two measures of MRD measured on the same remission specimens will be examined using scatterplots and correlation analysis. The prognostic effect for relapse of each measure will be illustrated using cumulative incidence plots, and estimated using Cox regression models. This outcome will be reported as funding allows.

Outcome measures

Outcome data not reported

Adverse Events

Induction/Consolidation

Serious events: 43 serious events

Other events: 89 other events

Deaths: 0 deaths

Vincristine/Prednisone/Dasatinib

Serious events: 5 serious events

Other events: 22 other events

Deaths: 0 deaths

Allogeneic Stem Cell Transplant

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Dasatinib

Serious events: 10 serious events

Other events: 36 other events

Deaths: 0 deaths

Serious adverse events

Measure	Induction/Consolidation n=93 participants at risk Patients receive up to 8 courses, alternating between hyper-CVAD plus dasatinib and high dose methotrexate and cytarabine plus dasatinib. There are nine possible induction/consolidation courses.	Vincristine/Prednisone/Dasatinib n=22 participants at risk Patients receive vincristine IV on day 1, prednisone PO on days 1 to 5, and dasatinib PO on days 1 to 28 for up to 24 courses or until transplant is available.	Allogeneic Stem Cell Transplant n=4 participants at risk Patients who have an available sibling donor or a 10/10 matched unrelated donor will be removed from therapy and proceed directly to allogeneic stem cell transplant after achieving CR or CRi.	Dasatinib n=39 participants at risk Patients receive Single-Agent Dasatinib therapy PO every day for up to five years from original registration.
Blood and lymphatic system disorders Febrile neutropenia	28.0% 26/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	4.5% 1/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Blood and lymphatic system disorders Hemoglobin	3.2% 3/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Cardiac disorders Pericarditis	0.00% 0/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	2.6% 1/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Cardiac disorders SVT and nodal arrhythmia - Atrial fibrillation	1.1% 1/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Cardiac disorders SVT and nodal arrhythmia - Sinus tachycardia	1.1% 1/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	2.6% 1/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Gastrointestinal disorders Colitis	2.2% 2/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	9.1% 2/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Gastrointestinal disorders Diarrhea	1.1% 1/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	2.6% 1/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Gastrointestinal disorders Enteritis (inflammation of the small bowel)	0.00% 0/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	25.0% 1/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Gastrointestinal disorders Gastrointestinal-Other	0.00% 0/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	2.6% 1/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Gastrointestinal disorders Mucositis/stomatitis (clinical exam) - Oral cavity	1.1% 1/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Gastrointestinal disorders Nausea	2.2% 2/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Gastrointestinal disorders Pain - Abdomen NOS	1.1% 1/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Gastrointestinal disorders Perforation, GI - Stomach	1.1% 1/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Gastrointestinal disorders Vomiting	2.2% 2/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
General disorders Edema: limb	0.00% 0/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	4.5% 1/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Infections and infestations Inf (clin/microbio) w/Gr 3-4 neuts - Blood	5.4% 5/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Infections and infestations Inf (clin/microbio) w/Gr 3-4 neuts - Catheter-rel	1.1% 1/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
General disorders Fatigue (asthenia, lethargy, malaise)	0.00% 0/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	4.5% 1/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
General disorders Fever in absence of neutropenia, ANC lt1.0x10e9/L	1.1% 1/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	2.6% 1/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
General disorders Pain - Chest/thorax NOS	0.00% 0/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	4.5% 1/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
General disorders Sudden death	1.1% 1/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Infections and infestations Colitis, infectious (e.g., Clostridium difficile)	1.1% 1/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	4.5% 1/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Infections and infestations Inf (clin/microbio) w/Gr 3-4 neuts - Skin	2.2% 2/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Infections and infestations Inf (clin/microbio) w/Gr 3-4 neuts - Upper airway	1.1% 1/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	4.5% 1/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Infections and infestations Inf w/normal ANC or Gr 1-2 neutrophils - Catheter	1.1% 1/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Infections and infestations Infection with unknown ANC - Blood	8.6% 8/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	4.5% 1/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Infections and infestations Infection with unknown ANC - Bronchus	1.1% 1/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Infections and infestations Infection with unknown ANC - Catheter-related	3.2% 3/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Infections and infestations Infection with unknown ANC - Lung (pneumonia)	5.4% 5/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	4.5% 1/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Infections and infestations Infection with unknown ANC - Meninges (meningitis)	0.00% 0/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	2.6% 1/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Infections and infestations Inf (clin/microbio) w/Gr 3-4 neuts - Lung	1.1% 1/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Investigations Lymphopenia	2.2% 2/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Investigations Metabolic/Laboratory-Other	1.1% 1/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Investigations Neutrophils/granulocytes (ANC/AGC)	7.5% 7/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Investigations Platelets	5.4% 5/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Metabolism and nutrition disorders Anorexia	0.00% 0/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	25.0% 1/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Metabolism and nutrition disorders Dehydration	3.2% 3/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Infections and infestations Infection with unknown ANC - Scrotum	0.00% 0/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	4.5% 1/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Infections and infestations Infection with unknown ANC - Sinus	1.1% 1/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Infections and infestations Infection with unknown ANC - Skin (cellulitis)	2.2% 2/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Nervous system disorders Neurology-Other	1.1% 1/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Infections and infestations Infection with unknown ANC - Soft tissue NOS	1.1% 1/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Nervous system disorders Neuropathy: motor	1.1% 1/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Infections and infestations Infection-Other	5.4% 5/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	4.5% 1/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	25.0% 1/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	7.7% 3/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Nervous system disorders Pain - Head/headache	2.2% 2/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Nervous system disorders Seizure	0.00% 0/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	2.6% 1/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Psychiatric disorders Confusion	1.1% 1/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Psychiatric disorders Mood alteration - anxiety	1.1% 1/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Vascular disorders Hemorrhage/Bleeding-Other	1.1% 1/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Vascular disorders Hypertension	1.1% 1/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Vascular disorders Hypotension	1.1% 1/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Vascular disorders Thrombosis/thrombus/embolism	1.1% 1/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	2.6% 1/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Investigations ALT, SGPT (serum glutamic pyruvic transaminase)	5.4% 5/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Investigations AST, SGOT	2.2% 2/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	4.5% 1/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Investigations Alkaline phosphatase	0.00% 0/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	4.5% 1/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Investigations Bilirubin (hyperbilirubinemia)	1.1% 1/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Investigations Carbon monoxide diffusion capacity (DL(co))	1.1% 1/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	25.0% 1/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	2.6% 1/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Investigations Creatinine	2.2% 2/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Investigations GGT (gamma-glutamyl transpeptidase)	1.1% 1/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Investigations Leukocytes (total WBC)	2.2% 2/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Musculoskeletal and connective tissue disorders Muscle weakness, not d/t neuropathy - Extrem-lower	1.1% 1/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Musculoskeletal and connective tissue disorders Pain - Back	1.1% 1/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Musculoskeletal and connective tissue disorders Pain - Joint	1.1% 1/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Musculoskeletal and connective tissue disorders Pain - Muscle	1.1% 1/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Musculoskeletal and connective tissue disorders Soft tissue necrosis - Extremity-lower	1.1% 1/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Secondary Malignancy-poss rel to cancer Tx	0.00% 0/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	2.6% 1/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Nervous system disorders Muscle weakness, not d/t neuropathy - Facial	0.00% 0/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	2.6% 1/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Psychiatric disorders Psychosis (hallucinations/delusions)	0.00% 0/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	4.5% 1/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Renal and urinary disorders Hemorrhage, GU - Urinary NOS	1.1% 1/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Renal and urinary disorders Renal failure	2.2% 2/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	2.6% 1/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Respiratory, thoracic and mediastinal disorders Adult respiratory distress syndrome (ARDS)	1.1% 1/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Respiratory, thoracic and mediastinal disorders Carbon monoxide diffusion capacity (DL(co))	1.1% 1/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	25.0% 1/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	2.6% 1/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Respiratory, thoracic and mediastinal disorders Cough	1.1% 1/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	4.5% 1/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	1.1% 1/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	25.0% 1/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Respiratory, thoracic and mediastinal disorders Pleural effusion (non-malignant)	2.2% 2/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	4.5% 1/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	2.6% 1/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Respiratory, thoracic and mediastinal disorders Pneumonitis/pulmonary infiltrates	1.1% 1/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Respiratory, thoracic and mediastinal disorders Pneumothorax	1.1% 1/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory-Other	1.1% 1/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	2.6% 1/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Skin and subcutaneous tissue disorders Petechiae/purpura (hemorrhage into skin or mucosa)	1.1% 1/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Vascular disorders Hematoma	1.1% 1/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	2.6% 1/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.

Other adverse events

Measure	Induction/Consolidation n=93 participants at risk Patients receive up to 8 courses, alternating between hyper-CVAD plus dasatinib and high dose methotrexate and cytarabine plus dasatinib. There are nine possible induction/consolidation courses.	Vincristine/Prednisone/Dasatinib n=22 participants at risk Patients receive vincristine IV on day 1, prednisone PO on days 1 to 5, and dasatinib PO on days 1 to 28 for up to 24 courses or until transplant is available.	Allogeneic Stem Cell Transplant n=4 participants at risk Patients who have an available sibling donor or a 10/10 matched unrelated donor will be removed from therapy and proceed directly to allogeneic stem cell transplant after achieving CR or CRi.	Dasatinib n=39 participants at risk Patients receive Single-Agent Dasatinib therapy PO every day for up to five years from original registration.
Musculoskeletal and connective tissue disorders Muscle weakness, not d/t neuropathy - body/general	10.8% 10/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	18.2% 4/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	7.7% 3/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Eye disorders Pain - Eye	7.5% 7/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	2.6% 1/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Eye disorders Vision-blurred vision	5.4% 5/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	27.3% 6/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	12.8% 5/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Gastrointestinal disorders Colitis	1.1% 1/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	4.5% 1/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	7.7% 3/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Gastrointestinal disorders Constipation	44.1% 41/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	45.5% 10/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	25.6% 10/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Gastrointestinal disorders Diarrhea	41.9% 39/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	27.3% 6/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	56.4% 22/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Gastrointestinal disorders Distention/bloating, abdominal	9.7% 9/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	4.5% 1/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	5.1% 2/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Gastrointestinal disorders Dry mouth/salivary gland (xerostomia)	1.1% 1/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	17.9% 7/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Gastrointestinal disorders Dysphagia (difficulty swallowing)	1.1% 1/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	5.1% 2/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Gastrointestinal disorders Gastrointestinal-Other	4.3% 4/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	9.1% 2/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	12.8% 5/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Gastrointestinal disorders Heartburn/dyspepsia	23.7% 22/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	13.6% 3/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	17.9% 7/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Gastrointestinal disorders Hemorrhoids	12.9% 12/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	4.5% 1/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	2.6% 1/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Gastrointestinal disorders Malabsorption	0.00% 0/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	5.1% 2/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Gastrointestinal disorders Mucositis/stomatitis (clinical exam) - Oral cavity	16.1% 15/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	4.5% 1/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	7.7% 3/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Gastrointestinal disorders Mucositis/stomatitis (functional/symp) - Oral cav	18.3% 17/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	4.5% 1/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	5.1% 2/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Gastrointestinal disorders Nausea	83.9% 78/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	50.0% 11/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	71.8% 28/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Gastrointestinal disorders Pain - Abdomen NOS	35.5% 33/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	27.3% 6/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	25.6% 10/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Gastrointestinal disorders Pain - Oral cavity	7.5% 7/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	4.5% 1/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	5.1% 2/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Gastrointestinal disorders Vomiting	54.8% 51/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	22.7% 5/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	59.0% 23/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
General disorders Edema: head and neck	10.8% 10/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	9.1% 2/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	12.8% 5/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
General disorders Edema: limb	33.3% 31/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	31.8% 7/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	53.8% 21/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
General disorders Edema: trunk/genital	1.1% 1/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	5.1% 2/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
General disorders Fatigue (asthenia, lethargy, malaise)	63.4% 59/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	50.0% 11/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	69.2% 27/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
General disorders Fever in absence of neutropenia, ANC lt1.0x10e9/L	32.3% 30/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	31.8% 7/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	28.2% 11/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
General disorders Flu-like syndrome	0.00% 0/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	12.8% 5/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
General disorders Injection site reaction/extravasation changes	4.3% 4/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	5.1% 2/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
General disorders Pain - Chest/thorax NOS	5.4% 5/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	13.6% 3/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	10.3% 4/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
General disorders Pain - Pain NOS	1.1% 1/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	10.3% 4/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
General disorders Pain-Other	10.8% 10/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	13.6% 3/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	23.1% 9/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
General disorders Rigors/chills	9.7% 9/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	13.6% 3/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	17.9% 7/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
General disorders Syndromes-Other	1.1% 1/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	7.7% 3/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Immune system disorders Allergic reaction/hypersensitivity	9.7% 9/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	9.1% 2/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	12.8% 5/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Immune system disorders Allergy/Immunology-Other	3.2% 3/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	7.7% 3/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Infections and infestations Colitis, infectious (e.g., Clostridium difficile)	5.4% 5/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	13.6% 3/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Infections and infestations Inf (clin/microbio) w/Gr 3-4 neuts - Blood	12.9% 12/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Infections and infestations Inf (clin/microbio) w/Gr 3-4 neuts - Lung	7.5% 7/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Infections and infestations Inf (clin/microbio) w/Gr 3-4 neuts - Oral cav-gums	5.4% 5/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Infections and infestations Inf w/normal ANC or Gr 1-2 neutrophils - Blood	1.1% 1/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	4.5% 1/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	5.1% 2/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Infections and infestations Inf w/normal ANC or Gr 1-2 neutrophils - Bronchus	1.1% 1/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	4.5% 1/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	5.1% 2/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Infections and infestations Inf w/normal ANC or Gr 1-2 neutrophils - Eye NOS	0.00% 0/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	5.1% 2/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Infections and infestations Inf w/normal ANC or Gr 1-2 neutrophils - Lung	7.5% 7/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	9.1% 2/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	10.3% 4/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Infections and infestations Inf w/normal ANC or Gr 1-2 neutrophils - Sinus	1.1% 1/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	4.5% 1/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	15.4% 6/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Infections and infestations Inf w/normal ANC or Gr 1-2 neutrophils - Skin	4.3% 4/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	10.3% 4/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Infections and infestations Inf w/normal ANC or Gr 1-2 neutrophils - UTI	2.2% 2/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	4.5% 1/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	10.3% 4/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Infections and infestations Inf w/normal ANC or Gr 1-2 neutrophils - Up airway	6.5% 6/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	4.5% 1/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	23.1% 9/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Infections and infestations Inf w/unknown ANC - Middle ear (otitis media)	0.00% 0/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	5.1% 2/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Infections and infestations Infection with unknown ANC - Upper airway NOS	0.00% 0/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	4.5% 1/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	7.7% 3/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Infections and infestations Infection with unknown ANC - Urinary tract NOS	1.1% 1/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	5.1% 2/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Infections and infestations Infection-Other	10.8% 10/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	27.3% 6/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	17.9% 7/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Injury, poisoning and procedural complications Bruising (in absence of Gr 3-4 thrombocytopenia)	8.6% 8/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	13.6% 3/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	17.9% 7/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Injury, poisoning and procedural complications Fracture	1.1% 1/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	4.5% 1/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	5.1% 2/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Investigations ALT, SGPT (serum glutamic pyruvic transaminase)	47.3% 44/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	54.5% 12/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	53.8% 21/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Investigations AST, SGOT	49.5% 46/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	54.5% 12/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	46.2% 18/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Investigations Alkaline phosphatase	29.0% 27/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	18.2% 4/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	30.8% 12/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Investigations Bilirubin (hyperbilirubinemia)	29.0% 27/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	12.8% 5/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Investigations Cholesterol, serum-high (hypercholesterolemia)	0.00% 0/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	13.6% 3/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	12.8% 5/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Investigations Creatinine	20.4% 19/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	18.2% 4/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	46.2% 18/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Investigations Fibrinogen	8.6% 8/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Investigations INR (of prothrombin time)	8.6% 8/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	4.5% 1/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	5.1% 2/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Investigations Leukocytes (total WBC)	64.5% 60/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	68.2% 15/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	48.7% 19/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Investigations Lymphopenia	43.0% 40/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	22.7% 5/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	43.6% 17/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Investigations Metabolic/Laboratory-Other	12.9% 12/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	9.1% 2/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	12.8% 5/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Investigations Neutrophils/granulocytes (ANC/AGC)	60.2% 56/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	40.9% 9/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	51.3% 20/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Investigations PTT (Partial thromboplastin time)	6.5% 6/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	4.5% 1/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Investigations Platelets	71.0% 66/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	50.0% 11/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	48.7% 19/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Investigations Weight gain	9.7% 9/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	9.1% 2/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	15.4% 6/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Investigations Weight loss	14.0% 13/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	23.1% 9/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Metabolism and nutrition disorders Albumin, serum-low (hypoalbuminemia)	43.0% 40/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	22.7% 5/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	30.8% 12/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Metabolism and nutrition disorders Anorexia	36.6% 34/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	13.6% 3/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	35.9% 14/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Metabolism and nutrition disorders Bicarbonate, serum-low	6.5% 6/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	5.1% 2/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Metabolism and nutrition disorders Calcium, serum-high (hypercalcemia)	0.00% 0/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	4.5% 1/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	5.1% 2/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Metabolism and nutrition disorders Calcium, serum-low (hypocalcemia)	52.7% 49/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	36.4% 8/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	41.0% 16/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Metabolism and nutrition disorders Dehydration	7.5% 7/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	4.5% 1/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	12.8% 5/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Metabolism and nutrition disorders Glucose, serum-high (hyperglycemia)	58.1% 54/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	36.4% 8/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	35.9% 14/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Metabolism and nutrition disorders Glucose, serum-low (hypoglycemia)	9.7% 9/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	9.1% 2/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	12.8% 5/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Metabolism and nutrition disorders Magnesium, serum-high (hypermagnesemia)	14.0% 13/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	4.5% 1/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	2.6% 1/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Metabolism and nutrition disorders Magnesium, serum-low (hypomagnesemia)	24.7% 23/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	13.6% 3/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	28.2% 11/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Metabolism and nutrition disorders Phosphate, serum-low (hypophosphatemia)	18.3% 17/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	4.5% 1/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	20.5% 8/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Metabolism and nutrition disorders Potassium, serum-high (hyperkalemia)	8.6% 8/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	4.5% 1/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	15.4% 6/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Metabolism and nutrition disorders Potassium, serum-low (hypokalemia)	62.4% 58/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	36.4% 8/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	30.8% 12/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Metabolism and nutrition disorders Sodium, serum-high (hypernatremia)	9.7% 9/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	13.6% 3/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	2.6% 1/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Metabolism and nutrition disorders Sodium, serum-low (hyponatremia)	29.0% 27/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	22.7% 5/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	23.1% 9/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Metabolism and nutrition disorders Triglyceride, serum-high (hypertriglyceridemia)	3.2% 3/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	9.1% 2/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	10.3% 4/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Metabolism and nutrition disorders Uric acid, serum-high (hyperuricemia)	6.5% 6/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	12.8% 5/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Musculoskeletal and connective tissue disorders Joint-function	0.00% 0/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	5.1% 2/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Musculoskeletal and connective tissue disorders Muscle weakness, not d/t neuropathy - Extrem-lower	2.2% 2/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	13.6% 3/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	10.3% 4/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Musculoskeletal and connective tissue disorders Pain - Muscle	17.2% 16/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	13.6% 3/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	33.3% 13/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Musculoskeletal and connective tissue disorders Pain - Neck	7.5% 7/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	13.6% 3/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	10.3% 4/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Nervous system disorders Dizziness	23.7% 22/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	18.2% 4/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	28.2% 11/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Nervous system disorders Memory impairment	0.00% 0/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	7.7% 3/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Nervous system disorders Neurology-Other	1.1% 1/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	4.5% 1/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	7.7% 3/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Nervous system disorders Neuropathy: motor	3.2% 3/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	9.1% 2/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	2.6% 1/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Nervous system disorders Neuropathy: sensory	29.0% 27/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	59.1% 13/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	51.3% 20/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Nervous system disorders Ocular/Visual-Other	6.5% 6/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	18.2% 4/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	10.3% 4/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Nervous system disorders Pain - Head/headache	59.1% 55/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	31.8% 7/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	61.5% 24/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Nervous system disorders Pain - Sinus	4.3% 4/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	7.7% 3/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Nervous system disorders Seizure	0.00% 0/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	9.1% 2/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	5.1% 2/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Nervous system disorders Speech impairment (e.g., dysphasia or aphasia)	0.00% 0/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	5.1% 2/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Nervous system disorders Taste alteration (dysgeusia)	6.5% 6/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	4.5% 1/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	5.1% 2/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Nervous system disorders Tremor	2.2% 2/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	15.4% 6/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Psychiatric disorders Insomnia	28.0% 26/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	27.3% 6/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	28.2% 11/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Psychiatric disorders Libido	1.1% 1/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	4.5% 1/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	5.1% 2/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Psychiatric disorders Mood alteration - anxiety	33.3% 31/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	22.7% 5/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	20.5% 8/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Psychiatric disorders Mood alteration - depression	16.1% 15/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	31.8% 7/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	28.2% 11/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Renal and urinary disorders Hemorrhage, GU - Urinary NOS	1.1% 1/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	5.1% 2/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Renal and urinary disorders Proteinuria	1.1% 1/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	5.1% 2/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Renal and urinary disorders Renal/Genitourinary-Other	3.2% 3/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	9.1% 2/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	7.7% 3/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Reproductive system and breast disorders Erectile dysfunction	0.00% 0/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	5.1% 2/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Reproductive system and breast disorders Vaginitis (not due to infection)	0.00% 0/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	5.1% 2/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	9.7% 9/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	18.2% 4/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	15.4% 6/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Respiratory, thoracic and mediastinal disorders Bronchospasm, wheezing	1.1% 1/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	4.5% 1/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	7.7% 3/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Respiratory, thoracic and mediastinal disorders Cough	23.7% 22/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	31.8% 7/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	53.8% 21/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	22.6% 21/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	13.6% 3/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	30.8% 12/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Skin and subcutaneous tissue disorders Dry skin	1.1% 1/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	4.5% 1/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	20.5% 8/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Skin and subcutaneous tissue disorders Hair loss/Alopecia (scalp or body)	22.6% 21/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	4.5% 1/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	10.3% 4/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Skin and subcutaneous tissue disorders Hyperpigmentation	0.00% 0/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	5.1% 2/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Skin and subcutaneous tissue disorders Hypopigmentation	0.00% 0/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	5.1% 2/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Reproductive system and breast disorders Gynecomastia	0.00% 0/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	4.5% 1/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	7.7% 3/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Reproductive system and breast disorders Hemorrhage, GU - Vagina	7.5% 7/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	7.7% 3/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Reproductive system and breast disorders Pain - Pelvis	1.1% 1/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	5.1% 2/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Reproductive system and breast disorders Sexual/Reproductive Function-Other	2.2% 2/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	9.1% 2/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	12.8% 5/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Reproductive system and breast disorders Vaginal dryness	0.00% 0/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	9.1% 2/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	2.6% 1/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Skin and subcutaneous tissue disorders Nail changes	3.2% 3/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	5.1% 2/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Skin and subcutaneous tissue disorders Pain - Skin	0.00% 0/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	4.5% 1/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	7.7% 3/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Skin and subcutaneous tissue disorders Urticaria (hives, welts, wheals)	2.2% 2/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	9.1% 2/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	5.1% 2/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Vascular disorders Flushing	4.3% 4/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	10.3% 4/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Vascular disorders Hot flashes/flushes	2.2% 2/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	9.1% 2/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	20.5% 8/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Vascular disorders Hypertension	11.8% 11/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	9.1% 2/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	23.1% 9/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Vascular disorders Hypotension	17.2% 16/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	4.5% 1/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	2.6% 1/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Vascular disorders Thrombosis/thrombus/embolism	12.9% 12/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	4.5% 1/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	2.6% 1/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Blood and lymphatic system disorders Lymphatics-Other	5.4% 5/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	7.7% 3/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Cardiac disorders Cardiac General-Other	3.2% 3/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	5.1% 2/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Cardiac disorders Pericardial effusion (non-malignant)	1.1% 1/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	12.8% 5/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Cardiac disorders SVT and nodal arrhythmia - Sinus tachycardia	11.8% 11/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	5.1% 2/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Endocrine disorders Cushingoid appearance	0.00% 0/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	5.1% 2/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Eye disorders Cataract	0.00% 0/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	7.7% 3/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Eye disorders Dry eye syndrome	2.2% 2/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	30.8% 12/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Eye disorders Ocular/Visual-Other	6.5% 6/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	18.2% 4/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	10.3% 4/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Blood and lymphatic system disorders Blood/Bone Marrow-Other	5.4% 5/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	4.5% 1/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	2.6% 1/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Blood and lymphatic system disorders Febrile neutropenia	30.1% 28/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	4.5% 1/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	2.6% 1/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Blood and lymphatic system disorders Hemoglobin	74.2% 69/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	63.6% 14/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	74.4% 29/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Musculoskeletal and connective tissue disorders Musculoskeletal/Soft Tissue-Other	2.2% 2/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	13.6% 3/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	15.4% 6/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Musculoskeletal and connective tissue disorders Pain - Back	28.0% 26/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	27.3% 6/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	20.5% 8/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Musculoskeletal and connective tissue disorders Pain - Bone	18.3% 17/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	4.5% 1/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	12.8% 5/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Musculoskeletal and connective tissue disorders Pain - Chest wall	5.4% 5/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	10.3% 4/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Musculoskeletal and connective tissue disorders Pain - Extremity-limb	10.8% 10/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	9.1% 2/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	30.8% 12/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Musculoskeletal and connective tissue disorders Pain - Joint	7.5% 7/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	9.1% 2/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	33.3% 13/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Respiratory, thoracic and mediastinal disorders Hemorrhage, pulmonary/upper respiratory - Nose	24.7% 23/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	4.5% 1/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Respiratory, thoracic and mediastinal disorders Hiccoughs (hiccups, singultus)	4.3% 4/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	4.5% 1/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	10.3% 4/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Respiratory, thoracic and mediastinal disorders Pain - Throat/pharynx/larynx	8.6% 8/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	13.6% 3/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	15.4% 6/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Respiratory, thoracic and mediastinal disorders Pleural effusion (non-malignant)	11.8% 11/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	9.1% 2/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	15.4% 6/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Respiratory, thoracic and mediastinal disorders Pneumonitis/pulmonary infiltrates	2.2% 2/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	13.6% 3/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	5.1% 2/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory-Other	9.7% 9/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	18.2% 4/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	15.4% 6/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Skin and subcutaneous tissue disorders Dermatology/Skin-Other	11.8% 11/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	9.1% 2/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	23.1% 9/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Skin and subcutaneous tissue disorders Petechiae/purpura (hemorrhage into skin or mucosa)	10.8% 10/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Skin and subcutaneous tissue disorders Photosensitivity	1.1% 1/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	7.7% 3/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Skin and subcutaneous tissue disorders Pruritus/itching	7.5% 7/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	22.7% 5/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	23.1% 9/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Skin and subcutaneous tissue disorders Rash/desquamation	31.2% 29/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	13.6% 3/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	59.0% 23/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Skin and subcutaneous tissue disorders Rash: acne/acneiform	3.2% 3/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	27.3% 6/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	17.9% 7/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Skin and subcutaneous tissue disorders Rash: hand-foot skin reaction	1.1% 1/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	5.1% 2/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.
Skin and subcutaneous tissue disorders Sweating (diaphoresis)	12.9% 12/93 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	18.2% 4/22 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	0.00% 0/4 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.	7.7% 3/39 • Up to 5 years Analysis includes eligible patients who were assessed for adverse events.

Additional Information

Leukemia Committee Statistician

SWOG Statistics and Data Management Center

Phone: (206) 667-4623

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60