Trial Outcomes & Findings for Perifosine in Patients With Relapsed/Refractory Waldenstrom's Macroglobulinemia (NCT NCT00422656)

Last Updated: 2017-12-26

Results Overview

OR rate is the percentage of patients achieving Complete Response (CR), Partial Response (PR) or Minimal Response (MR) during treatment based on criteria from the 2nd International Workshop on WM. (Weber D, Treon S, et al. Seminars in Oncology 2003). CR: Disappearance of serum monoclonal IgM protein (IgM M-protein) by immunofixation; no histologic evidence of bone marrow (BM) involvement, resolution of any adenopathy/organomegaly (confirmed by CT scan); PR: At least 50% reduction of IgM M-protein and at least 50% decrease in adenopathy/organomegaly on physical examination or on CT scan; and MR: At least 25% but less than 50% reduction of IgM M-protein by protein electrophoresis. Patients must have no new symptoms or signs of active disease.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

37 participants

Primary outcome timeframe

Disease was assessed every cycle for the first 12 months and every 3 months thereafter. The median duration of treatment with perifosine was 5.6 months (range, 1.8- 21.5+).

Results posted on

2017-12-26

Participant Flow

From October 2006 through November 2007, patients enrolled from the Dana-Farber Cancer Institute in Boston, MA as well as at the Community Hospital of Monterey Peninsula in Monterey, CA.

Participant milestones

Participant milestones
Measure	Perifosine Patients receive oral perifosine (150 mg) daily each cycle. Cycle duration is 28 days. After cycle 2, response is assessed and patients with stable or responding disease can continue for another 4 cycles or until disease progression (PD). Protocol treatment duration is 6 cycles but patients may receive perifosine maintenance per investigator discretion in absence of PD.
Overall Study STARTED	37
Overall Study COMPLETED	37
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Perifosine in Patients With Relapsed/Refractory Waldenstrom's Macroglobulinemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Perifosine n=37 Participants Patients receive oral perifosine (150 mg) daily each cycle. Cycle duration is 28 days. After cycle 2, response is assessed and patients with stable or responding disease can continue for another 4 cycles or until disease progression (PD). Protocol treatment duration is 6 cycles but patients may receive perifosine maintenance per investigator discretion in absence of PD.
Age, Continuous	65 years n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	36 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	36 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	37 Participants n=5 Participants

PRIMARY outcome

Timeframe: Disease was assessed every cycle for the first 12 months and every 3 months thereafter. The median duration of treatment with perifosine was 5.6 months (range, 1.8- 21.5+).

Population: The analysis dataset is comprised of all enrolled patients.

Outcome measures

Outcome measures
Measure	Perifosine n=37 Participants Patients receive oral perifosine (150 mg) daily each cycle. Cycle duration is 28 days. After cycle 2, response is assessed and patients with stable or responding disease can continue for another 4 cycles or until disease progression (PD). Protocol treatment duration is 6 cycles but patients may receive perifosine maintenance per investigator discretion in absence of PD.
Overall Response (OR) Rate	38 percentage of patients Interval 25.0 to 53.0

SECONDARY outcome

Timeframe: Disease was assessed every cycle for the first 12 months and every 3 months thereafter. Median follow-up time was 19.5 months and range up to 24 months.

Population: The analysis dataset is comprised of all enrolled patients.

TTP estimated using the Kaplan-Meier method is defined as the time from registration to disease progression (PD) based on criteria from the 2nd International Workshop on WM. (Weber D, Treon S, et al. Seminars in Oncology 2003) Patients without PD are censored at time of last disease assessment. PD: At least 25% increase in serum monoclonal IgM protein by electrophoresis confirmed with a second measurement at least 2 weeks apart, or progression of clinically significant findings due to disease (i.e., anemia, thrombocytopenia, leucopenia, bulky adenopathy/organomegaly) or symptoms (unexplained recurrent fever of at least 38.4oC, drenching night sweats, at least 10% body weight less, or hyperviscosity, neuropathy, symptomatic cryoglobulinemia, or amyloidosis) attributable to WM.

Outcome measures

Outcome measures
Measure	Perifosine n=37 Participants Patients receive oral perifosine (150 mg) daily each cycle. Cycle duration is 28 days. After cycle 2, response is assessed and patients with stable or responding disease can continue for another 4 cycles or until disease progression (PD). Protocol treatment duration is 6 cycles but patients may receive perifosine maintenance per investigator discretion in absence of PD.
Time to Progression (TTP)	12.6 months Interval 10.2 to 22.7

SECONDARY outcome

Timeframe: Disease was assessed every cycle for the first 12 months and every 3 months thereafter. Median follow-up time was 19.5 months and range up to 24 months.

Population: The analysis dataset is comprised of all enrolled patients.

PFS estimated using the Kaplan-Meier method is defined as the time from registration to death from any cause or disease progression (PD) based on criteria from the 2nd International Workshop on WM. (Weber D, Treon S, et al. Seminars in Oncology 2003) Patients alive without PD are censored at time of last disease assessment. PD: At least 25% increase in serum monoclonal IgM protein by electrophoresis confirmed with a second measurement at least 2 weeks apart, or progression of clinically significant findings due to disease (i.e., anemia, thrombocytopenia, leucopenia, bulky adenopathy/organomegaly) or symptoms (unexplained recurrent fever of at least 38.4oC, drenching night sweats, at least 10% body weight less, or hyperviscosity, neuropathy, symptomatic cryoglobulinemia, or amyloidosis) attributable to WM.

Outcome measures

Outcome measures
Measure	Perifosine n=37 Participants Patients receive oral perifosine (150 mg) daily each cycle. Cycle duration is 28 days. After cycle 2, response is assessed and patients with stable or responding disease can continue for another 4 cycles or until disease progression (PD). Protocol treatment duration is 6 cycles but patients may receive perifosine maintenance per investigator discretion in absence of PD.
Progression Free Survival (PFS)	12.6 months Interval 10.2 to 22.7

SECONDARY outcome

Timeframe: Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+).

Population: The analysis dataset is comprised of all enrolled patients.

The percentage of patients experiencing treatment-related grade 3-4 adverse events based on CTCAEv3 as reported on case report forms.

Outcome measures

Outcome measures
Measure	Perifosine n=37 Participants Patients receive oral perifosine (150 mg) daily each cycle. Cycle duration is 28 days. After cycle 2, response is assessed and patients with stable or responding disease can continue for another 4 cycles or until disease progression (PD). Protocol treatment duration is 6 cycles but patients may receive perifosine maintenance per investigator discretion in absence of PD.
Treatment-Related Grade 3-4 Adverse Event Rate	35 percentage of patients Interval 22.0 to 50.0

Adverse Events

Perifosine

Serious events: 14 serious events

Other events: 37 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Perifosine n=37 participants at risk Patients receive oral perifosine (150 mg) daily each cycle. Cycle duration is 28 days. After cycle 2, response is assessed and patients with stable or responding disease can continue for another 4 cycles or until disease progression (PD). Protocol treatment duration is 6 cycles but patients may receive perifosine maintenance per investigator discretion in absence of PD.
Blood and lymphatic system disorders Hemoglobin	2.7% 1/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Eye disorders Vision-blurred	2.7% 1/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Eye disorders Eye, pain	2.7% 1/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Diarrhea w/o prior colostomy	2.7% 1/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
General disorders Fatigue	2.7% 1/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Infections and infestations Infection Gr0-2 neut, bronchus	2.7% 1/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Investigations Leukocytes	13.5% 5/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Investigations Neutrophils	16.2% 6/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Musculoskeletal and connective tissue disorders Arthritis	5.4% 2/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Gastritis/Dyspepsia	2.7% 1/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Blood and lymphatic system disorders Hypokalemia	2.7% 1/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Blood and lymphatic system disorders Lymphopenia	2.7% 1/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.

Other adverse events

Other adverse events
Measure	Perifosine n=37 participants at risk Patients receive oral perifosine (150 mg) daily each cycle. Cycle duration is 28 days. After cycle 2, response is assessed and patients with stable or responding disease can continue for another 4 cycles or until disease progression (PD). Protocol treatment duration is 6 cycles but patients may receive perifosine maintenance per investigator discretion in absence of PD.
Ear and labyrinth disorders Tinnitus	5.4% 2/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Infections and infestations Infection Gr0-2 neut, eye NOS	2.7% 1/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Infections and infestations Infection Gr0-2 neut, lung	2.7% 1/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Infections and infestations Infection Gr0-2 neut, skin	2.7% 1/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Infections and infestations Infection Gr0-2 neut, upper airway	2.7% 1/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Infections and infestations Infection w/ unk ANC oral cavity/gums	2.7% 1/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Infections and infestations Infection w/ unk ANC upper airway NOS	2.7% 1/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Blood and lymphatic system disorders Hemoglobin	70.3% 26/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Cardiac disorders Palpitations	5.4% 2/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Ear and labyrinth disorders Hearing-other	2.7% 1/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Eye disorders Vision-blurred	21.6% 8/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Eye disorders Ocular-other	5.4% 2/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Eye disorders Eye, pain	10.8% 4/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Constipation	35.1% 13/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Diarrhea w/o prior colostomy	81.1% 30/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Distention/bloating, abdominal	5.4% 2/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Dry mouth	2.7% 1/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Flatulence	2.7% 1/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Gastritis	21.6% 8/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Dyspepsia	27.0% 10/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Hemorrhoids	2.7% 1/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Muco/stomatitis (symptom) oral cavity	5.4% 2/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Nausea	81.1% 30/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Vomiting	67.6% 25/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Oral cavity, hemorrhage	2.7% 1/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Rectum, hemorrhage	5.4% 2/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Abdomen, pain	8.1% 3/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Stomach, pain	10.8% 4/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
General disorders Fatigue	73.0% 27/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
General disorders Fever w/o neutropenia	8.1% 3/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
General disorders Rigors/chills	2.7% 1/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
General disorders Edema limb	5.4% 2/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
General disorders Pain-other	5.4% 2/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
General disorders Flu-like syndrome	8.1% 3/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Infections and infestations Infection Gr0-2 neut, middle ear	2.7% 1/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Infections and infestations Infection-other	5.4% 2/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Injury, poisoning and procedural complications Fracture	2.7% 1/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Investigations Haptoglobin	5.4% 2/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Investigations Leukocytes	54.1% 20/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Investigations Lymphopenia	10.8% 4/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Investigations Neutrophils	51.4% 19/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Investigations Platelets	8.1% 3/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Investigations Weight gain	5.4% 2/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Investigations Weight loss	27.0% 10/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Investigations INR	2.7% 1/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Investigations Alkaline phosphatase	13.5% 5/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Investigations ALT, SGPT	8.1% 3/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Investigations AST, SGOT	10.8% 4/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Investigations Bilirubin	18.9% 7/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Investigations Creatinine	24.3% 9/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Metabolism and nutrition disorders Anorexia	5.4% 2/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Metabolism and nutrition disorders Dehydration	2.7% 1/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Metabolism and nutrition disorders Hypoalbuminemia	64.9% 24/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Metabolism and nutrition disorders Alkalosis	2.7% 1/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Metabolism and nutrition disorders Bicarbonate	37.8% 14/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Metabolism and nutrition disorders Hypercalcemia	8.1% 3/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Metabolism and nutrition disorders Hypocalcemia	45.9% 17/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Metabolism and nutrition disorders Hyperglycemia	75.7% 28/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Metabolism and nutrition disorders Hypoglycemia	16.2% 6/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Metabolism and nutrition disorders Hypermagnesemia	2.7% 1/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Metabolism and nutrition disorders Hyperkalemia	2.7% 1/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Metabolism and nutrition disorders Hypokalemia	10.8% 4/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Metabolism and nutrition disorders Hypernatremia	51.4% 19/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Metabolism and nutrition disorders Hyponatremia	16.2% 6/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Metabolism and nutrition disorders Hyperuricemia	2.7% 1/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Musculoskeletal and connective tissue disorders Arthritis	8.1% 3/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Musculoskeletal and connective tissue disorders Joint effusion	2.7% 1/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Musculoskeletal and connective tissue disorders Musculoskeletal/soft tissue-other	5.4% 2/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Musculoskeletal and connective tissue disorders Back, pain	16.2% 6/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Musculoskeletal and connective tissue disorders Bone, pain	8.1% 3/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Musculoskeletal and connective tissue disorders Extremity-limb, pain	13.5% 5/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Musculoskeletal and connective tissue disorders Joint, pain	16.2% 6/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Nervous system disorders Taste disturbance	2.7% 1/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Nervous system disorders Cognitive disturbance	2.7% 1/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Nervous system disorders Dizziness	5.4% 2/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Nervous system disorders Extrapyramidal movement	2.7% 1/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Nervous system disorders Memory impairment	2.7% 1/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Nervous system disorders Neuropathy-sensory	24.3% 9/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Nervous system disorders Seizure	2.7% 1/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Nervous system disorders Head/headache	24.3% 9/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Nervous system disorders Sinus, pain	2.7% 1/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Psychiatric disorders Insomnia	2.7% 1/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Psychiatric disorders Confusion	8.1% 3/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Psychiatric disorders Depression	2.7% 1/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Psychiatric disorders Psychosis	2.7% 1/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Psychiatric disorders Libido	5.4% 2/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Renal and urinary disorders Hemoglobinuria	5.4% 2/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Renal and urinary disorders Urinary frequency/urgency	2.7% 1/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Respiratory, thoracic and mediastinal disorders Nose, hemorrhage	13.5% 5/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Respiratory, thoracic and mediastinal disorders Throat/pharynx/larynx, pain	5.4% 2/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Respiratory, thoracic and mediastinal disorders Cough	8.1% 3/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Respiratory, thoracic and mediastinal disorders Dyspnea	2.7% 1/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Respiratory, thoracic and mediastinal disorders Obstruction, airway-bronchus	2.7% 1/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Respiratory, thoracic and mediastinal disorders Voice changes/dysarthria	2.7% 1/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Skin and subcutaneous tissue disorders Odor (patient odor)	2.7% 1/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Skin and subcutaneous tissue disorders Sweating	21.6% 8/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Skin and subcutaneous tissue disorders Dry skin	5.4% 2/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Skin and subcutaneous tissue disorders Pruritus/itching	5.4% 2/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Skin and subcutaneous tissue disorders Rash/desquamation	5.4% 2/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Skin and subcutaneous tissue disorders Rash: acne/acneiform	5.4% 2/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Skin and subcutaneous tissue disorders Skin-other	5.4% 2/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Vascular disorders Hypertension	2.7% 1/37 • Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+). Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.

Additional Information

Irene M. Ghobrial, MD

Dana-Farber Cancer Institute

Phone: 617-632-4198

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place