Trial Outcomes & Findings for A Trial of Romidepsin for Progressive or Relapsed Peripheral T-cell Lymphoma (NCT NCT00426764)

NCT ID: NCT00426764

Last Updated: 2020-02-11

Results Overview

Complete Response (CR): \>75% decrease in size aggregate of nodal index lesions (large and small), complete disappearance of extranodal and non-index lesions; total disappearance of clinical disease including skin involvement; disease-related signs and symptoms, normalization of biochemical abnormalities and reduction in size of spleen or liver so no longer palpable. Unconfirmed CR: all above criteria except all nodal index lesions must have regressed \>75% in the sum of the product diameters (SPD) from baseline. Individual nodes previously confluent must have regressed by \>75% in their SPD.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

131 participants

Primary outcome timeframe

Response was assessed after every 2 cycles of treatment and at completion of therapy, up until 30 September 2012 (data cutoff for analysis). Maximum duration on study was 1931 days.

Results posted on

2020-02-11

Participant Flow

Participant milestones

Participant milestones
Measure	Romidepsin Participants received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
Overall Study STARTED	131
Overall Study Discontinued Prior to or During Cycle 6	98
Overall Study Discontinued at End of or After Cycle 6	33
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	131

Reasons for withdrawal

Reasons for withdrawal
Measure	Romidepsin Participants received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
Overall Study Protocol Violation	1
Overall Study Withdrawal by Subject	4
Overall Study Physician Decision	6
Overall Study Compassionate Use	1
Overall Study Progressive Disease	83
Overall Study Adverse Event	24
Overall Study Other	1
Overall Study Death	1
Overall Study Other Reasons (Miscellaneous)	10

Baseline Characteristics

participants with a Baseline measurement

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Romidepsin n=131 Participants Participants received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Participants who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
Age, Continuous	59.4 years STANDARD_DEVIATION 12.83 • n=131 Participants
Sex: Female, Male Female	42 Participants n=131 Participants
Sex: Female, Male Male	89 Participants n=131 Participants
Race/Ethnicity, Customized White	116 Participants n=131 Participants
Race/Ethnicity, Customized Black	7 Participants n=131 Participants
Race/Ethnicity, Customized Asian	3 Participants n=131 Participants
Race/Ethnicity, Customized Other	4 Participants n=131 Participants
Race/Ethnicity, Customized Unknown	1 Participants n=131 Participants
Body Surface Area (BSA)	1.84 m^2 STANDARD_DEVIATION 0.2348 • n=128 Participants • participants with a Baseline measurement
Eastern Cooperative Oncology Group Performance Status 0	46 Participants n=131 Participants
Eastern Cooperative Oncology Group Performance Status 1	66 Participants n=131 Participants
Eastern Cooperative Oncology Group Performance Status 2	17 Participants n=131 Participants
Eastern Cooperative Oncology Group Performance Status Missing	1 Participants n=131 Participants
Eastern Cooperative Oncology Group Performance Status Unknown	1 Participants n=131 Participants
Duration of peripheral T-cell lymphoma (PTCL)	2.268 years STANDARD_DEVIATION 2.6654 • n=131 Participants
PTCL Subtype Based on Central Diagnosis PTCL Unspecified (NOS)	69 Participants n=131 Participants
PTCL Subtype Based on Central Diagnosis Angioimmunoblastic T-cell lymphoma (AITL)	27 Participants n=131 Participants
PTCL Subtype Based on Central Diagnosis ALK-1 negative ALCL	21 Participants n=131 Participants
PTCL Subtype Based on Central Diagnosis Enteropathy-type T-cell lymphoma	6 Participants n=131 Participants
PTCL Subtype Based on Central Diagnosis Subcutaneous panniculitis-like T-cell lymphoma	3 Participants n=131 Participants
PTCL Subtype Based on Central Diagnosis ALK-1 positive ALCL	1 Participants n=131 Participants
PTCL Subtype Based on Central Diagnosis Cutaneous γδ T-cell lymphoma	1 Participants n=131 Participants
PTCL Subtype Based on Central Diagnosis Extranodal NK/T cell lymphoma nasal type	1 Participants n=131 Participants
PTCL Subtype Based on Central Diagnosis Transformed mycosis fungoides	1 Participants n=131 Participants
PTCL Subtype Based on Central Diagnosis Unknown	1 Participants n=131 Participants

PRIMARY outcome

Timeframe: Response was assessed after every 2 cycles of treatment and at completion of therapy, up until 30 September 2012 (data cutoff for analysis). Maximum duration on study was 1931 days.

Population: Histologically Confirmed Population, comprised all enrolled patients who received at least 1 dose of study treatment and who had histopathologically confirmed peripheral T-cell lymphoma(s). Patients who discontinued prior to any response evaluation or who had no post-baseline assessment of response were classified as non-responders.

Complete Response (CR): \>75% decrease in size aggregate of nodal index lesions (large and small), complete disappearance of extranodal and non-index lesions; total disappearance of clinical disease including skin involvement; disease-related signs and symptoms, normalization of biochemical abnormalities and reduction in size of spleen or liver so no longer palpable. Unconfirmed CR: all above criteria except all nodal index lesions must have regressed \>75% in the sum of the product diameters (SPD) from baseline. Individual nodes previously confluent must have regressed by \>75% in their SPD.

Outcome measures

Outcome measures
Measure	Romidepsin n=130 Participants Participants received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.	Best ECOG = 0 Participants with a best on study ECOG performance score of 0, who received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.	Best ECOG = 1 Participants with a best on study ECOG performance score of 1, who received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.	Best ECOG = 2 Participants with a best on study ECOG performance score of 2, who received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.	Best ECOG = 3 Participants with a best on study ECOG performance score of 3, who received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.	Best ECOG = 4 Participants with a best on study ECOG performance score of 4, who received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
Percentage of Participants With a Complete Response According to the International Workshop Response Criteria (IWC) for Non-Hodgkin's Lymphomas (NHL) Assessed by an Independent Review Committee	15.4 percentage of participants Interval 9.7 to 22.8	—	—	—	—	—

SECONDARY outcome

Timeframe: Response was assessed after every 2 cycles of treatment and at completion of therapy, up until 30 September 2012 (data cutoff for analysis). Maximum duration on study was 1931 days.

Population: Histologically Confirmed Population. Patients who discontinued prior to any response evaluation or who had no post-baseline assessment of response were classified as non-responders.

Objective disease response was defined as patients with a Complete Response, Unconfirmed Complete Response or a Partial Response (PR) according to the IWC 1999 assessed by an independent review committee: CR, Cru defined above, PR defined as ≥50% decrease in size of 6 largest dominant nodes and/or nodal masses \& extranodal index lesions and no increase of non-index lesions, liver, or spleen; no new sites of disease evident; skin lesions decreased by ≥50%.

Outcome measures

Outcome measures
Measure	Romidepsin n=130 Participants Participants received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.	Best ECOG = 0 Participants with a best on study ECOG performance score of 0, who received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.	Best ECOG = 1 Participants with a best on study ECOG performance score of 1, who received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.	Best ECOG = 2 Participants with a best on study ECOG performance score of 2, who received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.	Best ECOG = 3 Participants with a best on study ECOG performance score of 3, who received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.	Best ECOG = 4 Participants with a best on study ECOG performance score of 4, who received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
Percentage of Participants With Objective Disease Response	26.2 percentage of participants Interval 18.8 to 34.6	—	—	—	—	—

SECONDARY outcome

Timeframe: Response was assessed after every 2 cycles of treatment and at completion of therapy, up until 30 September 2012 (data cutoff for analysis). Maximum duration on study was 1931 days.

Population: Histopathologically-Confirmed Population with an objective response. Censoring for patients who did not have a date of progression was conducted based on last assessment reported for the patient.

Duration of response was defined as the number of days from the date of the first disease response (Complete, Unconfirmed Complete or Partial Response) until the date of progression and was determined using Kaplan-Meier product-limit estimates. Progression was defined as: a ≥50% increase from the nadir in the individual sum of the products of the diameters of any index lesion; the reappearance of pathology, enlargement of liver/spleen, or unequivocal progression of non-measurable disease or appearance of any new lesions.

Outcome measures

Outcome measures
Measure	Romidepsin n=34 Participants Participants received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.	Best ECOG = 0 Participants with a best on study ECOG performance score of 0, who received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.	Best ECOG = 1 Participants with a best on study ECOG performance score of 1, who received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.	Best ECOG = 2 Participants with a best on study ECOG performance score of 2, who received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.	Best ECOG = 3 Participants with a best on study ECOG performance score of 3, who received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.	Best ECOG = 4 Participants with a best on study ECOG performance score of 4, who received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
Duration of Objective Disease Response	NA days Interval 353.0 to The median and the upper limit of the 95% confidence interval were not estimable due to the low number of events.	—	—	—	—	—

SECONDARY outcome

Timeframe: Response was assessed after every 2 cycles of treatment and at completion of therapy, up until 30 September 2012 (data cutoff for analysis). Maximum duration on study was 1931 days.

Population: Histopathologically-Confirmed Population with a complete response. Censoring for patients who did not have a date of progression was conducted based on last assessment reported for the patient.

Duration of response was defined as the number of days from the date of the first disease response (Complete or Unconfirmed Complete) until the date of progression and was determined using Kaplan-Meier product-limit estimates. Progression was defined as: a ≥50% increase from the nadir in the individual sum of the products of the diameters of any index lesion; the reappearance of pathology, enlargement of liver/spleen, or unequivocal progression of non-measurable disease or appearance of any new lesions.

Outcome measures

Outcome measures
Measure	Romidepsin n=20 Participants Participants received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.	Best ECOG = 0 Participants with a best on study ECOG performance score of 0, who received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.	Best ECOG = 1 Participants with a best on study ECOG performance score of 1, who received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.	Best ECOG = 2 Participants with a best on study ECOG performance score of 2, who received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.	Best ECOG = 3 Participants with a best on study ECOG performance score of 3, who received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.	Best ECOG = 4 Participants with a best on study ECOG performance score of 4, who received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
Duration of Complete Disease Response	NA days Interval 500.0 to Median and upper limit of the 95% confidence interval was not estimable due to the low number of events.	—	—	—	—	—

SECONDARY outcome

Timeframe: Response was assessed after every 2 cycles of treatment and at completion of therapy, up until 30 September 2012 (data cutoff for analysis). Maximum duration on study was 1931 days.

Population: Histopathologically-Confirmed Population. Censoring for patients who did not have a date of progression was conducted based on last assessment reported for the patient.

Time to progression (≥50% increase from the nadir in the individual sum of the products of the diameters of any index lesion; the reappearance of pathology, enlargement of liver/spleen, or unequivocal progression of non-measurable disease or appearance of any new lesions) was defined as the duration from the date of the first study drug dose to the date of relapse or progression as reported by the independent review committee and was determined using Kaplan-Meier product-limit estimates.

Outcome measures

Outcome measures
Measure	Romidepsin n=130 Participants Participants received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.	Best ECOG = 0 Participants with a best on study ECOG performance score of 0, who received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.	Best ECOG = 1 Participants with a best on study ECOG performance score of 1, who received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.	Best ECOG = 2 Participants with a best on study ECOG performance score of 2, who received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.	Best ECOG = 3 Participants with a best on study ECOG performance score of 3, who received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.	Best ECOG = 4 Participants with a best on study ECOG performance score of 4, who received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
Time to Disease Progression	182 days Interval 106.0 to 290.0	—	—	—	—	—

SECONDARY outcome

Timeframe: From Baseline up until 30 September 2012 (data cutoff for analysis). Maximum duration on study was 1931 days.

Population: Safety Population: all participants who received at least 1 dose of romidepsin.

The ECOG scale is as follows: Grade 0: Fully active, able to perform all pre-disease activities without restriction; Grade 1: Restricted in physically strenuous activity, ambulatory, able to carry out light work; Grade 2: Ambulatory and capable of all self-care but unable to work. Up and about more than 50% of waking hours; Grade 3: Capable of only limited self-care, confined to bed or chair \> 50% of waking hours; Grade 4: Completely disabled. Cannot carry on any self-care. Confined to bed or chair. Data reported is the shift from Baseline ECOG score to best on-study assessment score.

Outcome measures

Outcome measures
Measure	Romidepsin n=5 Participants Participants received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.	Best ECOG = 0 n=40 Participants Participants with a best on study ECOG performance score of 0, who received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.	Best ECOG = 1 n=57 Participants Participants with a best on study ECOG performance score of 1, who received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.	Best ECOG = 2 n=19 Participants Participants with a best on study ECOG performance score of 2, who received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.	Best ECOG = 3 n=6 Participants Participants with a best on study ECOG performance score of 3, who received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.	Best ECOG = 4 n=4 Participants Participants with a best on study ECOG performance score of 4, who received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
Change in Eastern Cooperative Oncology Group (ECOG) Performance Status Missing Baseline ECOG Score	1 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Change in Eastern Cooperative Oncology Group (ECOG) Performance Status Baseline ECOG Score = 0	2 participants	26 participants	16 participants	1 participants	0 participants	1 participants
Change in Eastern Cooperative Oncology Group (ECOG) Performance Status Baseline ECOG Score = 1	1 participants	13 participants	35 participants	12 participants	4 participants	2 participants
Change in Eastern Cooperative Oncology Group (ECOG) Performance Status Baseline ECOG Score = 2	1 participants	1 participants	6 participants	6 participants	2 participants	1 participants
Change in Eastern Cooperative Oncology Group (ECOG) Performance Status Baseline ECOG Score = 3	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Change in Eastern Cooperative Oncology Group (ECOG) Performance Status Baseline ECOG Score = 4	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: From first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. Mean duration of treatment up until 30 September 2012 (data cutoff for analysis) was 169 days.

Population: Safety Population: all participants who received at least 1 dose of romidepsin.

An adverse event or experience (AE) is defined as any untoward medical occurrence, which does not necessarily have to have a causal relationship with this treatment. A serious AE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event or condition. Related AEs are defined as those considered by the Investigator to have a possible, probable, or very likely/certain relationship to the study drug. AEs were graded as mild (1), moderate (2), severe (3), lifethreatening (4), or death (5). TEAEs occurred from the first dose of study medication through the end of the study (30 days post last dose) or any event that was present at baseline but worsened in intensity or was subsequently considered drug-related by the Investigator through end of study.

Outcome measures

Outcome measures
Measure	Romidepsin n=131 Participants Participants received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.	Best ECOG = 0 Participants with a best on study ECOG performance score of 0, who received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.	Best ECOG = 1 Participants with a best on study ECOG performance score of 1, who received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.	Best ECOG = 2 Participants with a best on study ECOG performance score of 2, who received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.	Best ECOG = 3 Participants with a best on study ECOG performance score of 3, who received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.	Best ECOG = 4 Participants with a best on study ECOG performance score of 4, who received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) TEAE	128 Participants	—	—	—	—	—
Number of Participants With Treatment Emergent Adverse Events (TEAEs) ≥ Grade 3 TEAE	89 Participants	—	—	—	—	—
Number of Participants With Treatment Emergent Adverse Events (TEAEs) ≥ Grade 4 TEAE	27 Participants	—	—	—	—	—
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Serious TEAE	61 Participants	—	—	—	—	—
Number of Participants With Treatment Emergent Adverse Events (TEAEs) TEAE Leading to Discontinuation	25 Participants	—	—	—	—	—
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Deaths within 30 days of Last Dose	8 Participants	—	—	—	—	—

Adverse Events

Romidepsin

Serious events: 62 serious events

Other events: 124 other events

Deaths: 9 deaths

Serious adverse events

Serious adverse events
Measure	Romidepsin n=131 participants at risk Participants received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
Metabolism and nutrition disorders Dehydration	2.3% 3/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Blood and lymphatic system disorders Anaemia	2.3% 3/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Blood and lymphatic system disorders Anaemia haemolytic autoimmune	1.5% 2/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Blood and lymphatic system disorders Febrile neutropenia	3.1% 4/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Blood and lymphatic system disorders Leukopenia	2.3% 3/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Blood and lymphatic system disorders Neutropenia	2.3% 3/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Blood and lymphatic system disorders Pancytopenia	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Blood and lymphatic system disorders Thrombocytopenia	1.5% 2/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Cardiac disorders Cardiogenic shock	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Cardiac disorders Subendocardial ischaemia	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Cardiac disorders Supraventricular tachycardia	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Eye disorders Angle closure glaucoma	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Gastrointestinal disorders Abdominal pain	3.1% 4/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Gastrointestinal disorders Colitis	1.5% 2/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Gastrointestinal disorders Diarrhoea	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Gastrointestinal disorders Gastric ulcer	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Gastrointestinal disorders Intussusception	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Gastrointestinal disorders Nausea	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Gastrointestinal disorders Pancreatitis	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Gastrointestinal disorders Peritonitis	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Gastrointestinal disorders Small intestinal obstruction	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Gastrointestinal disorders Vomiting	4.6% 6/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
General disorders Asthenia	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
General disorders Chest pain	2.3% 3/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
General disorders Chills	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
General disorders Fatigue	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
General disorders Multi-organ failure	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
General disorders Oedema peripheral	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
General disorders Pain	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
General disorders Pyrexia	8.4% 11/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Immune system disorders Cytokine release syndrome	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Immune system disorders Hypersensitivity	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Infections and infestations Candida sepsis	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Infections and infestations Catheter related infection	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Infections and infestations Cellulitis	3.8% 5/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Infections and infestations Erysipelas	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Infections and infestations Herpes zoster	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Infections and infestations Infection	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Infections and infestations Oral candidiasis	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Infections and infestations Pneumocystis jiroveci pneumonia	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Infections and infestations Pneumonia	5.3% 7/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Infections and infestations Respiratory tract infection	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Infections and infestations Sepsis	4.6% 6/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Infections and infestations Septic shock	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Infections and infestations Sinusitis	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Infections and infestations Staphylococcal infection	1.5% 2/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Infections and infestations Urinary tract infection	1.5% 2/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Infections and infestations Viral upper respiratory tract infection	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Investigations Aspartate aminotransferase increased	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Investigations Aspiration tracheal	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Investigations C-reactive protein increased	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Investigations Ejection fraction decreased	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Investigations Electrocardiogram QT prolonged	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Investigations Electrocardiogram T wave inversion	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Investigations Electrocardiogram repolarisation abnormality	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Investigations Hepatic enzyme increased	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Investigations Liver function test abnormal	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Metabolism and nutrition disorders Failure to thrive	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Metabolism and nutrition disorders Hypercalcaemia	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Metabolism and nutrition disorders Hyponatraemia	1.5% 2/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Metabolism and nutrition disorders Magnesium deficiency	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Metabolism and nutrition disorders Tumour lysis syndrome	1.5% 2/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Musculoskeletal and connective tissue disorders Arthralgia	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Musculoskeletal and connective tissue disorders Muscular weakness	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Musculoskeletal and connective tissue disorders Periarthritis	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Musculoskeletal and connective tissue disorders Tendon disorder	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour flare	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Nervous system disorders Cerebrovascular accident	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Nervous system disorders Dizziness	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Nervous system disorders Lethargy	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Nervous system disorders Polyneuropathy	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Nervous system disorders Somnolence	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Nervous system disorders Syncope	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Psychiatric disorders Mental status changes	1.5% 2/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Renal and urinary disorders Hydronephrosis	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Renal and urinary disorders Nephrolithiasis	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Renal and urinary disorders Pelvi-ureteric obstruction	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Renal and urinary disorders Proteinuria	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Renal and urinary disorders Renal failure	1.5% 2/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Renal and urinary disorders Renal failure acute	1.5% 2/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Renal and urinary disorders Urinary retention	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.3% 3/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Respiratory, thoracic and mediastinal disorders Hypoxia	1.5% 2/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	2.3% 3/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Vascular disorders Deep vein thrombosis	3.8% 5/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Vascular disorders Hypotension	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Vascular disorders Thrombosis	0.76% 1/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.

Other adverse events

Other adverse events
Measure	Romidepsin n=131 participants at risk Participants received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
Blood and lymphatic system disorders Neutropenia	28.2% 37/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Blood and lymphatic system disorders Thrombocytopenia	40.5% 53/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Cardiac disorders Tachycardia	9.9% 13/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Blood and lymphatic system disorders Anaemia	24.4% 32/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Blood and lymphatic system disorders Leukopenia	11.5% 15/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Gastrointestinal disorders Abdominal pain	11.5% 15/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Gastrointestinal disorders Abdominal pain upper	6.9% 9/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Gastrointestinal disorders Constipation	29.8% 39/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Gastrointestinal disorders Diarrhoea	35.1% 46/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Gastrointestinal disorders Dyspepsia	9.2% 12/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Gastrointestinal disorders Nausea	58.0% 76/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Gastrointestinal disorders Stomatitis	10.7% 14/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Gastrointestinal disorders Vomiting	36.6% 48/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
General disorders Asthenia	16.8% 22/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
General disorders Chest pain	6.1% 8/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
General disorders Chills	10.7% 14/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
General disorders Fatigue	40.5% 53/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
General disorders Oedema	5.3% 7/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
General disorders Oedema peripheral	9.9% 13/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
General disorders Pain	7.6% 10/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
General disorders Pyrexia	33.6% 44/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Infections and infestations Nasopharyngitis	5.3% 7/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Infections and infestations Oral candidiasis	5.3% 7/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Infections and infestations Upper respiratory tract infection	9.2% 12/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Infections and infestations Urinary tract infection	5.3% 7/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Investigations Weight decreased	10.7% 14/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Metabolism and nutrition disorders Anorexia	29.0% 38/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Metabolism and nutrition disorders Decreased appetite	9.2% 12/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Metabolism and nutrition disorders Hypokalaemia	10.7% 14/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Metabolism and nutrition disorders Hypomagnesaemia	6.9% 9/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Musculoskeletal and connective tissue disorders Arthralgia	5.3% 7/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Musculoskeletal and connective tissue disorders Back pain	6.9% 9/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Musculoskeletal and connective tissue disorders Muscle spasms	9.2% 12/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Musculoskeletal and connective tissue disorders Myalgia	6.1% 8/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Musculoskeletal and connective tissue disorders Pain in extremity	5.3% 7/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Nervous system disorders Dizziness	7.6% 10/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Nervous system disorders Dysgeusia	20.6% 27/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Nervous system disorders Headache	14.5% 19/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Nervous system disorders Lethargy	6.1% 8/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Psychiatric disorders Anxiety	6.9% 9/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Psychiatric disorders Insomnia	6.9% 9/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Respiratory, thoracic and mediastinal disorders Cough	18.3% 24/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Respiratory, thoracic and mediastinal disorders Dyspnoea	12.2% 16/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	6.1% 8/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	6.1% 8/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Skin and subcutaneous tissue disorders Dry skin	6.1% 8/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Skin and subcutaneous tissue disorders Night sweats	6.9% 9/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Skin and subcutaneous tissue disorders Pruritus	9.2% 12/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Skin and subcutaneous tissue disorders Rash	8.4% 11/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Skin and subcutaneous tissue disorders Skin lesion	8.4% 11/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
Vascular disorders Hypotension	7.6% 10/131 • Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days. NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.

Additional Information

Associate Director, Clinical Trials Disclosure

Celgene Corporation

Phone: 1-888-260-1599

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Upon investigator submission of a publication or presentation to Celgene, Celgene shall complete its review within 60 days after receipt of the proposed publication or presentation. Upon Celgene's request, proposed publication or presentation will be delayed up to 60 additional days to enable Celgene to secure adequate intellectual property protection of property of Celgene that would be affected by such proposed publication or presentation.
Publication restrictions are in place

Restriction type: OTHER