Trial Outcomes & Findings for Vorinostat, Rituximab, and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Diffuse Large B-Cell Lymphoma (NCT NCT00972478)

NCT ID: NCT00972478

Last Updated: 2025-09-09

Results Overview

Safe dose of Vorinostat (in combination with R-CHOP) at which 3/10 or fewer patients have doselimiting toxicities (DLT). Toxicities graded according to the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE 4.0). DLT apply only during cycle 1 and should be drug-related (possible, probable, or definite).

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE1/PHASE2
• Target enrollment: 83 participants
• Primary outcome timeframe: 21 days
• Results posted on: 2025-09-09

Participant Flow

Participant milestones

Measure	Ph I: R-CHOP+Vorinostat (400mg D1-9) Patients receive vorinostat 400 mg PO once daily on days 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.	Ph II: R-CHOP+Vorinostat Patients receive vorinostat 400 mg PO once daily on days 1-5 or 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	11	72
Overall Study Eligible and Began Protocol Therapy	9	63
Overall Study COMPLETED	4	34
Overall Study NOT COMPLETED	7	38

Reasons for withdrawal

Measure	Ph I: R-CHOP+Vorinostat (400mg D1-9) Patients receive vorinostat 400 mg PO once daily on days 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.	Ph II: R-CHOP+Vorinostat Patients receive vorinostat 400 mg PO once daily on days 1-5 or 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Overall Study Adverse Event	3	16
Overall Study Withdrawal by Subject	1	8
Overall Study Progression/Relapse	0	2
Overall Study Death	0	2
Overall Study Not protocol specified	1	1
Overall Study Ineligible	1	7
Overall Study Not start protocol treatment	1	2

Baseline Characteristics

Vorinostat, Rituximab, and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Diffuse Large B-Cell Lymphoma

Baseline characteristics by cohort

Measure	Ph I: R-CHOP+Vorinostat (400mg D1-9) n=9 Participants Patients receive vorinostat 400 mg PO once daily on days 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.	Ph II: R-CHOP+Vorinostat n=63 Participants Patients receive vorinostat 400 mg PO once daily on days 1-5 or 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.	Total n=72 Participants Total of all reporting groups
Age, Continuous	66.9 years n=5 Participants	64.1 years n=7 Participants	64.2 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	27 Participants n=7 Participants	30 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	36 Participants n=7 Participants	42 Participants n=5 Participants
Race/Ethnicity, Customized White	9 participants n=5 Participants	54 participants n=7 Participants	63 participants n=5 Participants
Race/Ethnicity, Customized Black	0 participants n=5 Participants	3 participants n=7 Participants	3 participants n=5 Participants
Race/Ethnicity, Customized Asian	0 participants n=5 Participants	5 participants n=7 Participants	5 participants n=5 Participants
Race/Ethnicity, Customized Unknown	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	3 participants n=5 Participants	4 participants n=7 Participants	7 participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic	6 participants n=5 Participants	59 participants n=7 Participants	65 participants n=5 Participants

PRIMARY outcome

Timeframe: 21 days

Population: Phase I eligible patients receiving any amount of the assigned dose during Cycle 1 (1 Cycle = 21 days) or whom developed a dose-limiting toxicity (DLT).

Safe dose of Vorinostat (in combination with R-CHOP) at which 3/10 or fewer patients have doselimiting toxicities (DLT). Toxicities graded according to the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE 4.0). DLT apply only during cycle 1 and should be drug-related (possible, probable, or definite).

Outcome measures

Measure	Ph I: R-CHOP+Vorinostat (400mg D1-9) n=9 Participants Patients receive vorinostat 400 mg PO once daily on days 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.	Ph II: R-CHOP+Vorinostat Patients receive vorinostat 400 mg PO once daily on days 1-5 or 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Safe Dose of Vorinostat to be Used in Combination With R-CHOP Assessed by CTCAE Version 4.0 (Phase I)	400 mg PO Once daily Days 1-9	—

PRIMARY outcome

Timeframe: Up to 2 years

Population: Eligible patients who received the protocol treatment in the Phase II portion of the study.

From date of registration to date of first documentation of progressive disease, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact.

Outcome measures

Measure	Ph I: R-CHOP+Vorinostat (400mg D1-9) n=63 Participants Patients receive vorinostat 400 mg PO once daily on days 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.	Ph II: R-CHOP+Vorinostat Patients receive vorinostat 400 mg PO once daily on days 1-5 or 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Progression-free Survival (Phase II)	73 percentage of participants Interval 59.6 to 81.9	—

SECONDARY outcome

Timeframe: Up to 2 years

Population: Eligible patients who received the protocol treatment in the Phase II portion of the study.

From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.

Outcome measures

Measure	Ph I: R-CHOP+Vorinostat (400mg D1-9) n=63 Participants Patients receive vorinostat 400 mg PO once daily on days 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.	Ph II: R-CHOP+Vorinostat Patients receive vorinostat 400 mg PO once daily on days 1-5 or 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Overall Survival (Phase II)	86 percentage of participants Interval 74.3 to 92.3	—

SECONDARY outcome

Timeframe: Up to week 26

Population: Eligible patients who received the protocol treatment in the Phase II portion of the study

Objective disease status is evaluated according to the 2007 revised Cheson et al. criteria. Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow (BM) must be negative if positive at baseline. Normalization of markers. Partial Response (PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.

Outcome measures

Measure	Ph I: R-CHOP+Vorinostat (400mg D1-9) n=63 Participants Patients receive vorinostat 400 mg PO once daily on days 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.	Ph II: R-CHOP+Vorinostat Patients receive vorinostat 400 mg PO once daily on days 1-5 or 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Response Rate (Complete Response [CR]+Partial Response [PR]) (Phase II)	81 percentage of participants Interval 69.1 to 89.8	—

SECONDARY outcome

Timeframe: Up to week 26

Population: Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 4.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.

Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.

Outcome measures

Measure	Ph I: R-CHOP+Vorinostat (400mg D1-9) n=9 Participants Patients receive vorinostat 400 mg PO once daily on days 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.	Ph II: R-CHOP+Vorinostat n=63 Participants Patients receive vorinostat 400 mg PO once daily on days 1-5 or 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Anorexia	1 Participants	2 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Bronchial infection	0 Participants	1 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Creatinine increased	1 Participants	0 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Cystitis noninfective	0 Participants	1 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Dehydration	2 Participants	4 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Depression	1 Participants	0 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Diarrhea	2 Participants	2 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Dizziness	1 Participants	0 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Electrocardiogram QT corrected interval prolonged	1 Participants	1 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Generalized muscle weakness	2 Participants	2 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Hematuria	1 Participants	0 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Hiccups	0 Participants	1 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Hyperglycemia	0 Participants	4 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Urinary tract infection	0 Participants	3 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Urinary tract pain	0 Participants	2 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Hypocalcemia	1 Participants	0 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Hypokalemia	2 Participants	8 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Hyponatremia	0 Participants	6 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Left ventricular systolic dysfunction	0 Participants	1 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Leukocytosis	0 Participants	1 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Lung infection	0 Participants	4 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Lymphocyte count decreased	4 Participants	20 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Mucosal infection	0 Participants	1 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Mucositis oral	1 Participants	3 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Multi-organ failure	1 Participants	0 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Myalgia	1 Participants	2 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Myocardial infarction	0 Participants	2 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Neutrophil count decreased	8 Participants	37 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Obstruction gastric	0 Participants	1 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Pain	0 Participants	1 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Paronychia	0 Participants	1 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Small intestinal obstruction	0 Participants	1 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Abdominal pain	1 Participants	3 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Acute kidney injury	0 Participants	1 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Alanine aminotransferase increased	0 Participants	1 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Weight loss	0 Participants	3 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL White blood cell decreased	7 Participants	32 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Anemia	4 Participants	22 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Aspartate aminotransferase increased	0 Participants	1 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Atrial fibrillation	0 Participants	1 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Bladder spasm	0 Participants	1 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL CD4 lymphocytes decreased	0 Participants	1 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL CPK increased	0 Participants	1 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Carbon monoxide diffusing capacity decreased	0 Participants	1 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Colitis	1 Participants	0 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Disseminated intravascular coagulation	1 Participants	0 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Duodenal perforation	0 Participants	1 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Dysphagia	0 Participants	1 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Dyspnea	0 Participants	1 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Fatigue	3 Participants	9 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Febrile neutropenia	3 Participants	24 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Fecal incontinence	0 Participants	1 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Gastrointestinal disorders - Other, specify	0 Participants	1 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Hypoalbuminemia	1 Participants	3 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Hypophosphatemia	1 Participants	2 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Hypotension	0 Participants	3 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Infections and infestations - Other, specify	1 Participants	3 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Jejunal perforation	0 Participants	1 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Nausea	1 Participants	3 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Peripheral motor neuropathy	1 Participants	0 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Platelet count decreased	4 Participants	22 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Pneumonitis	0 Participants	1 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Recurrent laryngeal nerve palsy	0 Participants	1 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Respiratory failure	0 Participants	1 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Sepsis	3 Participants	11 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Sinus tachycardia	0 Participants	1 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Sinusitis	0 Participants	1 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Stoma site infection	0 Participants	1 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Syncope	0 Participants	4 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Urine output decreased	1 Participants	0 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Vasovagal reaction	0 Participants	1 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Visceral arterial ischemia	1 Participants	0 Participants
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL Vomiting	0 Participants	2 Participants

Adverse Events

Ph I: R-CHOP+Vorinostat (400mg D1-9)

Serious events: 5 serious events

Other events: 9 other events

Deaths: 0 deaths

Ph II: R-CHOP+Vorinostat

Serious events: 44 serious events

Other events: 63 other events

Deaths: 0 deaths

Serious adverse events

Measure	Ph I: R-CHOP+Vorinostat (400mg D1-9) n=9 participants at risk Patients receive vorinostat 400 mg PO once daily on days 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.	Ph II: R-CHOP+Vorinostat n=63 participants at risk Patients receive vorinostat 400 mg PO once daily on days 1-5 or 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Blood and lymphatic system disorders Anemia	33.3% 3/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	20.6% 13/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Blood and lymphatic system disorders Disseminated intravascular coagulation	11.1% 1/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	0.00% 0/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Blood and lymphatic system disorders Febrile neutropenia	33.3% 3/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	34.9% 22/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Cardiac disorders Atrial fibrillation	0.00% 0/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	1.6% 1/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Cardiac disorders Cardiac arrest	0.00% 0/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	1.6% 1/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Cardiac disorders Left ventricular systolic dysfunction	0.00% 0/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	1.6% 1/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Cardiac disorders Myocardial infarction	0.00% 0/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	4.8% 3/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Gastrointestinal disorders Abdominal pain	11.1% 1/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	1.6% 1/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Gastrointestinal disorders Colitis	11.1% 1/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	0.00% 0/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Gastrointestinal disorders Constipation	0.00% 0/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	1.6% 1/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Gastrointestinal disorders Diarrhea	0.00% 0/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	1.6% 1/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Gastrointestinal disorders Dysphagia	0.00% 0/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	1.6% 1/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Gastrointestinal disorders Gastroesophageal reflux disease	0.00% 0/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	1.6% 1/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Gastrointestinal disorders Gastrointestinal disorders-Other	0.00% 0/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	3.2% 2/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Gastrointestinal disorders Jejunal perforation	0.00% 0/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	1.6% 1/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Gastrointestinal disorders Mucositis oral	11.1% 1/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	0.00% 0/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Gastrointestinal disorders Nausea	0.00% 0/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	3.2% 2/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	1.6% 1/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Gastrointestinal disorders Vomiting	0.00% 0/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	3.2% 2/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
General disorders Death NOS	0.00% 0/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	1.6% 1/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
General disorders Fatigue	11.1% 1/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	4.8% 3/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
General disorders Fever	0.00% 0/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	3.2% 2/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
General disorders Malaise	0.00% 0/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	1.6% 1/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
General disorders Multi-organ failure	11.1% 1/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	0.00% 0/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
General disorders Non-cardiac chest pain	0.00% 0/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	1.6% 1/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
General disorders Pain	0.00% 0/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	3.2% 2/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Infections and infestations Bronchial infection	0.00% 0/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	1.6% 1/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Infections and infestations Infections and infestations-Other	0.00% 0/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	3.2% 2/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Infections and infestations Lung infection	11.1% 1/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	6.3% 4/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Infections and infestations Paronychia	0.00% 0/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	1.6% 1/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Infections and infestations Sepsis	33.3% 3/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	12.7% 8/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Infections and infestations Sinusitis	0.00% 0/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	1.6% 1/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Infections and infestations Stoma site infection	0.00% 0/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	1.6% 1/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Infections and infestations Urinary tract infection	0.00% 0/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	3.2% 2/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Investigations Aspartate aminotransferase increased	0.00% 0/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	1.6% 1/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Investigations Creatinine increased	11.1% 1/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	3.2% 2/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Investigations Electrocardiogram QT corrected interval prolonged	11.1% 1/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	1.6% 1/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Investigations Lymphocyte count decreased	11.1% 1/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	6.3% 4/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Investigations Neutrophil count decreased	33.3% 3/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	25.4% 16/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Investigations Platelet count decreased	44.4% 4/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	25.4% 16/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Investigations Weight loss	0.00% 0/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	1.6% 1/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Investigations White blood cell decreased	22.2% 2/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	15.9% 10/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Metabolism and nutrition disorders Anorexia	0.00% 0/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	3.2% 2/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Metabolism and nutrition disorders Dehydration	11.1% 1/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	6.3% 4/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Metabolism and nutrition disorders Hypercalcemia	0.00% 0/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	1.6% 1/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Metabolism and nutrition disorders Hypoalbuminemia	0.00% 0/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	1.6% 1/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Metabolism and nutrition disorders Hypocalcemia	11.1% 1/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	0.00% 0/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Metabolism and nutrition disorders Hypokalemia	22.2% 2/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	4.8% 3/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Metabolism and nutrition disorders Hypophosphatemia	11.1% 1/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	0.00% 0/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	1.6% 1/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified - Other	0.00% 0/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	1.6% 1/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Nervous system disorders Cognitive disturbance	0.00% 0/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	1.6% 1/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Nervous system disorders Dizziness	0.00% 0/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	1.6% 1/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Nervous system disorders Recurrent laryngeal nerve palsy	0.00% 0/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	1.6% 1/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Nervous system disorders Reversible posterior leukoencephalopathy syndrome	0.00% 0/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	1.6% 1/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Nervous system disorders Syncope	0.00% 0/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	4.8% 3/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Psychiatric disorders Confusion	0.00% 0/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	3.2% 2/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Renal and urinary disorders Acute kidney injury	0.00% 0/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	1.6% 1/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Renal and urinary disorders Cystitis noninfective	0.00% 0/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	1.6% 1/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Renal and urinary disorders Urinary frequency	0.00% 0/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	1.6% 1/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Renal and urinary disorders Urinary tract pain	0.00% 0/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	1.6% 1/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	1.6% 1/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	1.6% 1/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	1.6% 1/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	3.2% 2/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	0.00% 0/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	1.6% 1/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	1.6% 1/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Vascular disorders Hypotension	0.00% 0/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	4.8% 3/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Vascular disorders Thromboembolic event	0.00% 0/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	3.2% 2/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Vascular disorders Visceral arterial ischemia	11.1% 1/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	0.00% 0/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.

Other adverse events

Measure	Ph I: R-CHOP+Vorinostat (400mg D1-9) n=9 participants at risk Patients receive vorinostat 400 mg PO once daily on days 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.	Ph II: R-CHOP+Vorinostat n=63 participants at risk Patients receive vorinostat 400 mg PO once daily on days 1-5 or 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Blood and lymphatic system disorders Anemia	100.0% 9/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	82.5% 52/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Cardiac disorders Sinus tachycardia	0.00% 0/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	14.3% 9/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Eye disorders Blurred vision	22.2% 2/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	12.7% 8/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Eye disorders Dry eye	22.2% 2/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	0.00% 0/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Eye disorders Eye disorders-Other	11.1% 1/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	0.00% 0/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Eye disorders Photophobia	11.1% 1/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	0.00% 0/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Eye disorders Watering eyes	11.1% 1/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	0.00% 0/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Gastrointestinal disorders Abdominal pain	22.2% 2/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	25.4% 16/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Gastrointestinal disorders Bloating	11.1% 1/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	4.8% 3/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Gastrointestinal disorders Constipation	55.6% 5/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	41.3% 26/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Gastrointestinal disorders Diarrhea	77.8% 7/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	49.2% 31/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Gastrointestinal disorders Dry mouth	33.3% 3/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	9.5% 6/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Gastrointestinal disorders Dyspepsia	0.00% 0/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	6.3% 4/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Gastrointestinal disorders Fecal incontinence	11.1% 1/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	1.6% 1/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Gastrointestinal disorders Gastrointestinal disorders-Other	22.2% 2/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	3.2% 2/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Gastrointestinal disorders Hemorrhoids	0.00% 0/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	6.3% 4/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Gastrointestinal disorders Mucositis oral	11.1% 1/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	34.9% 22/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Gastrointestinal disorders Nausea	88.9% 8/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	68.3% 43/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Gastrointestinal disorders Oral pain	11.1% 1/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	3.2% 2/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Gastrointestinal disorders Rectal mucositis	11.1% 1/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	0.00% 0/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Gastrointestinal disorders Vomiting	44.4% 4/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	34.9% 22/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
General disorders Chills	22.2% 2/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	15.9% 10/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
General disorders Edema face	33.3% 3/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	0.00% 0/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
General disorders Edema limbs	22.2% 2/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	27.0% 17/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
General disorders Fatigue	88.9% 8/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	71.4% 45/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
General disorders Fever	11.1% 1/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	28.6% 18/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
General disorders Gait disturbance	22.2% 2/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	4.8% 3/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
General disorders Infusion related reaction	0.00% 0/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	6.3% 4/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
General disorders Non-cardiac chest pain	0.00% 0/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	6.3% 4/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
General disorders Pain	44.4% 4/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	11.1% 7/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Infections and infestations Infections and infestations-Other	11.1% 1/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	6.3% 4/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Infections and infestations Mucosal infection	11.1% 1/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	4.8% 3/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Infections and infestations Peripheral nerve infection	11.1% 1/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	0.00% 0/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Infections and infestations Rhinitis infective	11.1% 1/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	3.2% 2/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Infections and infestations Skin infection	11.1% 1/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	7.9% 5/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Infections and infestations Urinary tract infection	11.1% 1/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	7.9% 5/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Infections and infestations Wound infection	11.1% 1/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	0.00% 0/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Injury, poisoning and procedural complications Bruising	22.2% 2/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	4.8% 3/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Injury, poisoning and procedural complications Fall	11.1% 1/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	3.2% 2/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Injury, poisoning and procedural complications Fracture	11.1% 1/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	0.00% 0/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Investigations Activated partial thromboplastin time prolonged	11.1% 1/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	0.00% 0/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Investigations Alanine aminotransferase increased	22.2% 2/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	25.4% 16/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Investigations Alkaline phosphatase increased	0.00% 0/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	17.5% 11/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Investigations Aspartate aminotransferase increased	22.2% 2/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	20.6% 13/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Investigations Blood bilirubin increased	11.1% 1/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	6.3% 4/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Investigations CD4 lymphocytes decreased	0.00% 0/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	6.3% 4/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Investigations Cardiac troponin I increased	11.1% 1/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	1.6% 1/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Investigations Creatinine increased	11.1% 1/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	9.5% 6/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Investigations Electrocardiogram QT corrected interval prolonged	0.00% 0/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	7.9% 5/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Investigations Investigations-Other	22.2% 2/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	0.00% 0/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Investigations Lymphocyte count decreased	77.8% 7/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	41.3% 26/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Investigations Neutrophil count decreased	77.8% 7/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	55.6% 35/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Investigations Platelet count decreased	88.9% 8/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	50.8% 32/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Investigations Urine output decreased	11.1% 1/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	0.00% 0/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Investigations Weight gain	22.2% 2/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	6.3% 4/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Investigations Weight loss	22.2% 2/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	20.6% 13/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Investigations White blood cell decreased	88.9% 8/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	63.5% 40/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Metabolism and nutrition disorders Anorexia	66.7% 6/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	36.5% 23/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Metabolism and nutrition disorders Dehydration	22.2% 2/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	11.1% 7/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Metabolism and nutrition disorders Hyperglycemia	22.2% 2/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	19.0% 12/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Metabolism and nutrition disorders Hyperkalemia	22.2% 2/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	0.00% 0/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Metabolism and nutrition disorders Hypoalbuminemia	44.4% 4/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	31.7% 20/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Metabolism and nutrition disorders Hypocalcemia	33.3% 3/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	31.7% 20/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Metabolism and nutrition disorders Hypoglycemia	11.1% 1/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	6.3% 4/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Metabolism and nutrition disorders Hypokalemia	44.4% 4/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	27.0% 17/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Metabolism and nutrition disorders Hypomagnesemia	11.1% 1/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	12.7% 8/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Metabolism and nutrition disorders Hyponatremia	44.4% 4/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	36.5% 23/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Metabolism and nutrition disorders Hypophosphatemia	11.1% 1/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	11.1% 7/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specify	22.2% 2/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	1.6% 1/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	12.7% 8/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Musculoskeletal and connective tissue disorders Back pain	11.1% 1/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	15.9% 10/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Musculoskeletal and connective tissue disorders Bone pain	44.4% 4/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	14.3% 9/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Musculoskeletal and connective tissue disorders Chest wall pain	22.2% 2/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	7.9% 5/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Musculoskeletal and connective tissue disorders Flank pain	11.1% 1/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	0.00% 0/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	55.6% 5/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	19.0% 12/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Musculoskeletal and connective tissue disorders Muscle weakness upper limb	11.1% 1/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	0.00% 0/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Musculoskeletal and connective tissue disorders Myalgia	11.1% 1/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	14.3% 9/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	6.3% 4/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Musculoskeletal and connective tissue disorders Pain in extremity	22.2% 2/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	6.3% 4/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Nervous system disorders Dizziness	44.4% 4/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	31.7% 20/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Nervous system disorders Dysgeusia	33.3% 3/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	12.7% 8/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Nervous system disorders Headache	44.4% 4/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	31.7% 20/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Nervous system disorders Lethargy	11.1% 1/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	1.6% 1/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Nervous system disorders Memory impairment	11.1% 1/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	0.00% 0/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Nervous system disorders Movements involuntary	11.1% 1/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	0.00% 0/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Nervous system disorders Paresthesia	33.3% 3/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	1.6% 1/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Nervous system disorders Peripheral motor neuropathy	55.6% 5/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	6.3% 4/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Nervous system disorders Peripheral sensory neuropathy	44.4% 4/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	30.2% 19/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Nervous system disorders Tremor	11.1% 1/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	0.00% 0/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Psychiatric disorders Agitation	11.1% 1/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	0.00% 0/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Psychiatric disorders Anxiety	11.1% 1/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	14.3% 9/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Psychiatric disorders Confusion	11.1% 1/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	1.6% 1/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Psychiatric disorders Depression	33.3% 3/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	9.5% 6/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Psychiatric disorders Insomnia	66.7% 6/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	15.9% 10/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Renal and urinary disorders Hematuria	11.1% 1/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	6.3% 4/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Renal and urinary disorders Proteinuria	0.00% 0/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	11.1% 7/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Renal and urinary disorders Renal and urinary disorders-Other	11.1% 1/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	1.6% 1/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Renal and urinary disorders Urinary frequency	66.7% 6/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	7.9% 5/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Renal and urinary disorders Urinary incontinence	11.1% 1/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	3.2% 2/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Renal and urinary disorders Urinary retention	11.1% 1/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	0.00% 0/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	11.1% 1/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	4.8% 3/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Respiratory, thoracic and mediastinal disorders Cough	55.6% 5/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	23.8% 15/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Respiratory, thoracic and mediastinal disorders Dyspnea	22.2% 2/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	25.4% 16/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Respiratory, thoracic and mediastinal disorders Hiccups	22.2% 2/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	4.8% 3/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Respiratory, thoracic and mediastinal disorders Hypoxia	22.2% 2/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	0.00% 0/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Respiratory, thoracic and mediastinal disorders Postnasal drip	22.2% 2/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	1.6% 1/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Respiratory, thoracic and mediastinal disorders Resp, thoracic and mediastinal disorders - Other	11.1% 1/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	0.00% 0/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Respiratory, thoracic and mediastinal disorders Sore throat	11.1% 1/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	7.9% 5/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Skin and subcutaneous tissue disorders Alopecia	77.8% 7/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	33.3% 21/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Skin and subcutaneous tissue disorders Dry skin	11.1% 1/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	4.8% 3/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Skin and subcutaneous tissue disorders Erythema multiforme	22.2% 2/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	0.00% 0/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Skin and subcutaneous tissue disorders Hyperhidrosis	22.2% 2/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	3.2% 2/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Skin and subcutaneous tissue disorders Nail discoloration	22.2% 2/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	4.8% 3/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Skin and subcutaneous tissue disorders Pruritus	11.1% 1/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	4.8% 3/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Skin and subcutaneous tissue disorders Rash maculo-papular	44.4% 4/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	6.3% 4/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other	22.2% 2/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	6.3% 4/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	11.1% 1/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	0.00% 0/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Vascular disorders Hematoma	11.1% 1/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	0.00% 0/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Vascular disorders Hot flashes	11.1% 1/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	7.9% 5/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Vascular disorders Hypertension	44.4% 4/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	17.5% 11/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Vascular disorders Hypotension	22.2% 2/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	12.7% 8/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Vascular disorders Thromboembolic event	11.1% 1/9 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.	6.3% 4/63 • Up to week 26 Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.

Additional Information

Study Statistician

SWOG

Phone: 206-667-4623

Results disclosure agreements

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

Restriction type: LTE60