Trial Outcomes & Findings for Pomalidomide for Kaposi Sarcoma in People With or Without HIV (NCT NCT01495598)

NCT ID: NCT01495598

Last Updated: 2022-11-01

Results Overview

Adverse events (AE's) that are possibly, probably, and/or definitely attributed to pomalidomide were assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 28 participants
• Primary outcome timeframe: During each cycle and 4 weeks after completing therapy, with any continuing AE's observed until resolution, approximately 124 months and 1 day.
• Results posted on: 2022-11-01

Participant Flow

Participant milestones

Measure	Pomalidomide 5mg Daily All participants treated with pomalidomide 5 mg by mouth (p.o.) for 21 of 28 days.
Overall Study STARTED	28
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Measure	Pomalidomide 5mg Daily All participants treated with pomalidomide 5 mg by mouth (p.o.) for 21 of 28 days.
Overall Study Death during follow up period	2
Overall Study Death on study	1
Overall Study Lost to Follow-up	3
Overall Study Physician Decision	8

Baseline Characteristics

Pomalidomide for Kaposi Sarcoma in People With or Without HIV

Baseline characteristics by cohort

Measure	Pomalidomide 5mg Daily n=28 Participants All participants treated with pomalidomide 5 mg by mouth (p.o.) for 21 of 28 days.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Age, Continuous	52.5 years n=5 Participants
Sex/Gender, Customized Cisgender male	27 Participants n=5 Participants
Sex/Gender, Customized Transgender male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States	28 participants n=5 Participants
Prior Kaposi Sarcoma (KS) Therapy Prior systemic therapy	22 Participants n=5 Participants
Prior Kaposi Sarcoma (KS) Therapy Liposomal doxorubicin	14 Participants n=5 Participants
Prior Kaposi Sarcoma (KS) Therapy Paclitaxel	8 Participants n=5 Participants
Prior Kaposi Sarcoma (KS) Therapy Radiotherapy	9 Participants n=5 Participants
Prior Kaposi Sarcoma (KS) Therapy Immunomodulatory therapy	3 Participants n=5 Participants
Prior Kaposi Sarcoma (KS) Therapy Interferon alpha	5 Participants n=5 Participants
Prior Kaposi Sarcoma (KS) Therapy Local therapy	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: During each cycle and 4 weeks after completing therapy, with any continuing AE's observed until resolution, approximately 124 months and 1 day.

Adverse events (AE's) that are possibly, probably, and/or definitely attributed to pomalidomide were assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening.

Outcome measures

Measure	Grade 1 n=28 Participants Grade 1 is mild.	Grade 2 n=28 Participants Grade 2 is moderate.	Grade 3 n=28 Participants Grade 3 is severe.	Grade 4 n=28 Participants Grade 4 is life-threatening.	Quite a Bit Response on the HRQL questionnaire.	Very Much Response on the HRQL questionnaire.	Somewhat or MoreϮ Response on the HRQL questionnaire.
Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide Low white cell count	21 Participants	10 Participants	1 Participants	0 Participants	—	—	—
Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide Febrile neutropenia	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—
Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide Neutropenia	24 Participants	26 Participants	14 Participants	3 Participants	—	—	—
Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide Lymphocytopenia	13 Participants	2 Participants	0 Participants	0 Participants	—	—	—
Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide Anemia	16 Participants	4 Participants	0 Participants	0 Participants	—	—	—
Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide Thrombocytopenia	16 Participants	0 Participants	0 Participants	0 Participants	—	—	—
Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide Fatigue	17 Participants	2 Participants	0 Participants	0 Participants	—	—	—
Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide Infection	0 Participants	7 Participants	1 Participants	0 Participants	—	—	—
Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide Constipation	18 Participants	3 Participants	0 Participants	0 Participants	—	—	—
Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide Nausea	10 Participants	0 Participants	0 Participants	0 Participants	—	—	—
Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide Elevated alanine aminotransferase (ALT)	7 Participants	0 Participants	0 Participants	0 Participants	—	—	—
Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide Impaired concentration	3 Participants	1 Participants	0 Participants	0 Participants	—	—	—
Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide Depression	1 Participants	1 Participants	0 Participants	0 Participants	—	—	—
Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide Hypothyroidism	3 Participants	3 Participants	0 Participants	0 Participants	—	—	—
Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide Rash	18 Participants	6 Participants	1 Participants	0 Participants	—	—	—
Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide Vasculitis	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—

PRIMARY outcome

Timeframe: time from day 1 of pomalidomide therapy until progression requiring a change in therapy, an average of 9.97 months

PFS is defined as time from day 1 of pomalidomide therapy until progression requiring a change in therapy, estimated using the Kaplan-Meier method. Progression was assessed using the Modified Acquired Immunodeficiency Syndrome (AIDS) Clinical Trials Group criteria. Progressive disease (PD) involved a 25% or greater increase in total lesions, nodular lesion, or area of the five indicator lesions.

Outcome measures

Measure	Grade 1 n=28 Participants Grade 1 is mild.	Grade 2 n=18 Participants Grade 2 is moderate.	Grade 3 n=10 Participants Grade 3 is severe.	Grade 4 Grade 4 is life-threatening.	Quite a Bit Response on the HRQL questionnaire.	Very Much Response on the HRQL questionnaire.	Somewhat or MoreϮ Response on the HRQL questionnaire.
Progression Free Survival (PFS)	10.2 months Interval 7.6 to 15.7	10.3 months Interval 4.8 to 21.9	9.4 months Interval 6.0 to 26.0	—	—	—	—

PRIMARY outcome

Timeframe: At pre-dose, 1, 2, 3, 4, 6, and 8 hours after dose on Cycle 1 Day 1, and pre-dose, 1, 2, 3, 4, 6, 8, and 24 hours after dose on Cycle 1 Day 15.

Plasma concentrations of pomalidomide were assayed using high-performance liquid chromatography with fluorescence detection with a lower limit of quantitation of 1 ng/mL and were recorded as observed values. A non-compartmental analysis was used to calculate plasma pharmacokinetic parameters (Pharsight, Mountain View, California).

Outcome measures

Measure	Grade 1 n=28 Participants Grade 1 is mild.	Grade 2 Grade 2 is moderate.	Grade 3 Grade 3 is severe.	Grade 4 Grade 4 is life-threatening.	Quite a Bit Response on the HRQL questionnaire.	Very Much Response on the HRQL questionnaire.	Somewhat or MoreϮ Response on the HRQL questionnaire.
Maximal Plasma Concentration (Cmax) of Pomalidomide Cycle 1 Day 1	53.1 ng/mL Standard Deviation 27.0	—	—	—	—	—	—
Maximal Plasma Concentration (Cmax) of Pomalidomide Cycle 1 Day 15	59.0 ng/mL Standard Deviation 29.6	—	—	—	—	—	—

PRIMARY outcome

Timeframe: At pre-dose, 1, 2, 3, 4, 6, and 8 hours after dose on Cycle 1 Day 1, and pre-dose, 1, 2, 3, 4, 6, 8, and 24 hours after dose on Cycle 1 Day 15.

Time to maximum observed serum concentration of Pomalidomide was reported.

Outcome measures

Measure	Grade 1 n=28 Participants Grade 1 is mild.	Grade 2 Grade 2 is moderate.	Grade 3 Grade 3 is severe.	Grade 4 Grade 4 is life-threatening.	Quite a Bit Response on the HRQL questionnaire.	Very Much Response on the HRQL questionnaire.	Somewhat or MoreϮ Response on the HRQL questionnaire.
Time to Maximum Observed Serum Concentration of Pomalidomide (Cmax) Cycle 1 Day 1	2.00 hours Interval 1.0 to 8.0	—	—	—	—	—	—
Time to Maximum Observed Serum Concentration of Pomalidomide (Cmax) Cycle 1 day 15	2.08 hours Interval 1.0 to 8.0	—	—	—	—	—	—

PRIMARY outcome

Timeframe: At pre-dose, 1, 2, 3, 4, 6, and 8 hours after dose on Cycle 1 Day 1, and pre-dose, 1, 2, 3, 4, 6, 8, and 24 hours after dose on Cycle 1 Day 15.

Area under the plasma concentration versus time curve (AUC) was calculated using the log-linear trapezoidal method. The AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.

Outcome measures

Measure	Grade 1 n=28 Participants Grade 1 is mild.	Grade 2 Grade 2 is moderate.	Grade 3 Grade 3 is severe.	Grade 4 Grade 4 is life-threatening.	Quite a Bit Response on the HRQL questionnaire.	Very Much Response on the HRQL questionnaire.	Somewhat or MoreϮ Response on the HRQL questionnaire.
Area Under the Plasma Concentration Versus Time Curve (AUC) to the Last Timepoint (AUCLast) Cycle 1 Day 1	466.5 hours*ng/mL Standard Deviation 304	—	—	—	—	—	—
Area Under the Plasma Concentration Versus Time Curve (AUC) to the Last Timepoint (AUCLast) Cycle 1 Day 15	504.5 hours*ng/mL Standard Deviation 325.9	—	—	—	—	—	—

PRIMARY outcome

Timeframe: At pre-dose, 1, 2, 3, 4, 6, and 8 hours after dose on Cycle 1 Day 1, and pre-dose, 1, 2, 3, 4, 6, 8, and 24 hours after dose on Cycle 1 Day 15.

AUC is a measure of the serum concentration of Pomalidomide over time. It is used to characterize drug absorption. The AUC extrapolated to infinity was used, unless the percent extrapolated exceeded 25% in which case AUC to the last quantifiable time point (AUCLast) was used. The steady-state exposure on Day 15 of cycle 1 was calculated using AUCLast.

Outcome measures

Measure	Grade 1 n=28 Participants Grade 1 is mild.	Grade 2 Grade 2 is moderate.	Grade 3 Grade 3 is severe.	Grade 4 Grade 4 is life-threatening.	Quite a Bit Response on the HRQL questionnaire.	Very Much Response on the HRQL questionnaire.	Somewhat or MoreϮ Response on the HRQL questionnaire.
Area Under the Curve Extrapolated to Infinity (AUCinf) Cycle 1 Day 1	567.3 hours*ng/ml Standard Deviation 423.2	—	—	—	—	—	—
Area Under the Curve Extrapolated to Infinity (AUCinf) Cycle 1 Day 15	805.3 hours*ng/ml Standard Deviation 986.9	—	—	—	—	—	—

PRIMARY outcome

Timeframe: At pre-dose, 1, 2, 3, 4, 6, and 8 hours after dose on Cycle 1 Day 1, and pre-dose, 1, 2, 3, 4, 6, 8, and 24 hours after dose on Cycle 1 Day 15.

Plasma decay half-life is the time measured for the plasma concentration of the drug to decrease by one half.

Outcome measures

Measure	Grade 1 n=28 Participants Grade 1 is mild.	Grade 2 Grade 2 is moderate.	Grade 3 Grade 3 is severe.	Grade 4 Grade 4 is life-threatening.	Quite a Bit Response on the HRQL questionnaire.	Very Much Response on the HRQL questionnaire.	Somewhat or MoreϮ Response on the HRQL questionnaire.
Half-Life of Pomalidomide Cycle 1 Day 1	6.85 hours Standard Deviation 2.13	—	—	—	—	—	—
Half-Life of Pomalidomide Cycle 1 Day 15	8.27 hours Standard Deviation 6.61	—	—	—	—	—	—

SECONDARY outcome

Timeframe: After completion of 2 cycles of therapy up to 48 weeks after the start of the second course of Pomalidomide

Population: 4/28 participants were eligible for a second course of pomalidomide at time of progression within 12 months of treatment cessation.

Antitumor effect of pomalidomide was assessed at the established tolerated dose after a second course of pomalidomide. Kaposi sarcoma responses were assessed using the Modified Acquired Immunodeficiency Syndrome (AIDS) Clinical Trials Group criteria. Complete Response (CR) required clinical resolution of all lesions and tumor-associated phenomenon with biopsy confirmation. Clinical Complete Response (cCR) is resolution of all lesions except for some residual pigmentation but who did not have a biopsy of a representative pigmented area. Partial Response (PR) required ≥ 50% decrease in the number of lesions and/or sum product of the diameters of marker lesions and/or nodularity of lesions, and no new lesions in previously uninvolved areas or criteria. Stable Disease (SD) was assessed for all participants who did not meet criteria doe CR, PR, or PD. And progressive disease (PD) involved a 25% or greater increase in total lesions, nodular lesion, or area of the five indicator lesions.

Outcome measures

Measure	Grade 1 n=4 Participants Grade 1 is mild.	Grade 2 Grade 2 is moderate.	Grade 3 Grade 3 is severe.	Grade 4 Grade 4 is life-threatening.	Quite a Bit Response on the HRQL questionnaire.	Very Much Response on the HRQL questionnaire.	Somewhat or MoreϮ Response on the HRQL questionnaire.
Antitumor Effect of a Second Course of Pomalidomide Complete Response (CR)	0 Participants	—	—	—	—	—	—
Antitumor Effect of a Second Course of Pomalidomide Clinical Complete Response (CCR)	0 Participants	—	—	—	—	—	—
Antitumor Effect of a Second Course of Pomalidomide Partial Response (PR)	2 Participants	—	—	—	—	—	—
Antitumor Effect of a Second Course of Pomalidomide Stable Disease (SD)	2 Participants	—	—	—	—	—	—
Antitumor Effect of a Second Course of Pomalidomide Progressive Disease (PD)	0 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: After completion of 2 cycles of therapy up to 48 weeks

Antitumor effect of pomalidomide was assessed at the established tolerated dose after a first course of pomalidomide. Kaposi sarcoma responses were assessed using the Modified Acquired Immunodeficiency Syndrome (AIDS) Clinical Trials Group criteria. Complete Response (CR) required clinical resolution of all lesions and tumor-associated phenomenon with biopsy confirmation. Clinical Complete Response (cCR) is resolution of all lesions except for some residual pigmentation but who did not have a biopsy of a representative pigmented area. Partial Response (PR) required ≥ 50% decrease in the number of lesions and/or sum product of the diameters of marker lesions and/or nodularity of lesions, and no new lesions in previously uninvolved areas or criteria. Stable Disease (SD) was assessed for all participants who did not meet criteria doe CR, PR, or PD. And progressive disease (PD) involved a 25% or greater increase in total lesions, nodular lesion, or area of the five indicator lesions.

Outcome measures

Measure	Grade 1 n=28 Participants Grade 1 is mild.	Grade 2 Grade 2 is moderate.	Grade 3 Grade 3 is severe.	Grade 4 Grade 4 is life-threatening.	Quite a Bit Response on the HRQL questionnaire.	Very Much Response on the HRQL questionnaire.	Somewhat or MoreϮ Response on the HRQL questionnaire.
Antitumor Effect of a First Course of Pomalidomide Complete Response (CR)	1 Participants	—	—	—	—	—	—
Antitumor Effect of a First Course of Pomalidomide Clinical Complete Response (CCR)	3 Participants	—	—	—	—	—	—
Antitumor Effect of a First Course of Pomalidomide Partial Response (PR)	16 Participants	—	—	—	—	—	—
Antitumor Effect of a First Course of Pomalidomide Stable Disease (SD)	5 Participants	—	—	—	—	—	—
Antitumor Effect of a First Course of Pomalidomide Progressive Disease (PD)	3 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, after 3 months of therapy, and after completion of therapy, up to 48 weeks

Population: Missing responses within questionnaire in category FAHI Total at baseline (n=21). And missing responses within questionnaire in category FAHI Total after completion of therapy (n=17).

Changes in quality of life in participants receiving pomalidomide. HRQL was analyzed using a mixed-model repeated-measures analysis for FAHI and the marginal homogeneity test for Kaposi sarcoma-specific questions such as physical well-being (PWB), emotional well-being (EWB), functional and global well-being (FGWB), social well-being (SWB), and cognitive functioning (CF). The range of possible scores for each subscale was as follows: PWB and EWB, 0 to 40; FGWB, 0 to 52; SWB, 0 to 32; CF, 0 to 12. The total FAHI score, with possible scores ranging from 0 to 176, was calculated as the sum of all five subscale values, with higher scores indicating better results. Questionnaires completed at early withdrawal visits were not included in the analyses.

Outcome measures

Measure	Grade 1 n=22 Participants Grade 1 is mild.	Grade 2 n=19 Participants Grade 2 is moderate.	Grade 3 n=19 Participants Grade 3 is severe.	Grade 4 Grade 4 is life-threatening.	Quite a Bit Response on the HRQL questionnaire.	Very Much Response on the HRQL questionnaire.	Somewhat or MoreϮ Response on the HRQL questionnaire.
Self-Reported Health-Related Quality of Life (HRQL) Instrument: Functional Assessment of Human Immunodeficiency Virus Infection (FAHI) FAHI Total	123.0 score on a scale Standard Deviation 30.2	123.4 score on a scale Standard Deviation 28.4	118. score on a scale Standard Deviation 29.0	—	—	—	—
Self-Reported Health-Related Quality of Life (HRQL) Instrument: Functional Assessment of Human Immunodeficiency Virus Infection (FAHI) Physical well-being	30.8 score on a scale Standard Deviation 8.7	31.3 score on a scale Standard Deviation 8.2	31.3 score on a scale Standard Deviation 9.1	—	—	—	—
Self-Reported Health-Related Quality of Life (HRQL) Instrument: Functional Assessment of Human Immunodeficiency Virus Infection (FAHI) Emotional well-being	25.1 score on a scale Standard Deviation 7.6	27.7 score on a scale Standard Deviation 7.5	26.2 score on a scale Standard Deviation 7.7	—	—	—	—
Self-Reported Health-Related Quality of Life (HRQL) Instrument: Functional Assessment of Human Immunodeficiency Virus Infection (FAHI) Functional and global well-being	34.4 score on a scale Standard Deviation 10.3	34.5 score on a scale Standard Deviation 10.1	32.9 score on a scale Standard Deviation 9.6	—	—	—	—
Self-Reported Health-Related Quality of Life (HRQL) Instrument: Functional Assessment of Human Immunodeficiency Virus Infection (FAHI) Social well-being	22.1 score on a scale Standard Deviation 6.6	21.5 score on a scale Standard Deviation 7.8	20.9 score on a scale Standard Deviation 6.8	—	—	—	—
Self-Reported Health-Related Quality of Life (HRQL) Instrument: Functional Assessment of Human Immunodeficiency Virus Infection (FAHI) Cognitive functioning	9.1 score on a scale Standard Deviation 2.7	8.5 score on a scale Standard Deviation 2.7	8.7 score on a scale Standard Deviation 2.3	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, timepoint 1: after 3 months of therapy, and timepoint 2: 1 month after completion of therapy

Population: 22 participants were analyzed at baseline. 19/22 participants were evaluable and analyzed at timepoint 2 and timepoint 3 because the QOL data was not collected on the other three participants at those timepoints. Baseline n=22, timepoint 2 = 19, and timepoint 3 = 19. \*Sum of two preceding columns. ϮSum of three preceding columns.

The number of participants responding to each question with the indicated responses is shown. Changes in quality of life in participants receiving pomalidomide. HRQL was analyzed using a mixed-model repeated-measures analysis and the marginal homogeneity test for Kaposi sarcoma-specific questions. Three supplemental questions addressing pain, swelling, and satisfaction with physical appearance was used to collect quality of life data.

Outcome measures

Measure	Grade 1 n=22 Participants Grade 1 is mild.	Grade 2 n=22 Participants Grade 2 is moderate.	Grade 3 n=22 Participants Grade 3 is severe.	Grade 4 n=22 Participants Grade 4 is life-threatening.	Quite a Bit n=22 Participants Response on the HRQL questionnaire.	Very Much n=22 Participants Response on the HRQL questionnaire.	Somewhat or MoreϮ n=22 Participants Response on the HRQL questionnaire.
Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions Pain has interfered with my normal work or activities at baseline	10 Participants	3 Participants	13 Participants	2 Participants	5 Participants	2 Participants	9 Participants
Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions Pain has interfered with my normal work or activities - timepoint 2: after 3 months of therapy	7 Participants	5 Participants	12 Participants	5 Participants	1 Participants	1 Participants	7 Participants
Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions Pain has interfered with my normal work or activities timepoint 3:1month after completion of therapy	7 Participants	5 Participants	12 Participants	4 Participants	1 Participants	2 Participants	7 Participants
Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions I am satisfied with my physical appearance at baseline	6 Participants	6 Participants	12 Participants	6 Participants	3 Participants	1 Participants	10 Participants
Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions I am satisfied with my physical appearance - timepoint 2: after 3 months of therapy	6 Participants	1 Participants	7 Participants	5 Participants	5 Participants	2 Participants	12 Participants
Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions I am satisfied with my physical appearance - timepoint 3: 1 month after completion of therapy	3 Participants	2 Participants	5 Participants	5 Participants	8 Participants	1 Participants	14 Participants
Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions I have had swelling in my face, arms, or legs at baseline	6 Participants	2 Participants	8 Participants	5 Participants	4 Participants	5 Participants	14 Participants
Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions I have had swelling in my face, arms, or legs - timepoint 2: after 3 months of therapy	7 Participants	2 Participants	9 Participants	4 Participants	4 Participants	2 Participants	10 Participants
Number of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions I have had swelling in my face, arms, or legs - timepoint 3: 1 month after completion of therapy	6 Participants	3 Participants	9 Participants	4 Participants	5 Participants	1 Participants	10 Participants

SECONDARY outcome

Timeframe: Baseline to 4 weeks, baseline to 8 weeks and baseline to end of treatment

Cytokines were evaluated using MSD 96-Well Multiarray Proinflammatory 7-plex assay (MesoScale Discovery).

Outcome measures

Measure	Grade 1 n=28 Participants Grade 1 is mild.	Grade 2 n=28 Participants Grade 2 is moderate.	Grade 3 n=28 Participants Grade 3 is severe.	Grade 4 Grade 4 is life-threatening.	Quite a Bit Response on the HRQL questionnaire.	Very Much Response on the HRQL questionnaire.	Somewhat or MoreϮ Response on the HRQL questionnaire.
Change in Cytokines From Baseline to 4 Weeks, Baseline to 8 Weeks and End of Treatment Interferon gamma (ƴ)	-0.3 pg/mL Interval -4.7 to 1.4	-0.4 pg/mL Interval -7.4 to 4.5	-2.4 pg/mL Interval -5.3 to 55.1	—	—	—	—
Change in Cytokines From Baseline to 4 Weeks, Baseline to 8 Weeks and End of Treatment Interleukin 4 (IL4)	0.07 pg/mL Interval 0.02 to 0.1	0.1 pg/mL Interval 0.04 to 0.2	0.06 pg/mL Interval 0.001 to 0.1	—	—	—	—
Change in Cytokines From Baseline to 4 Weeks, Baseline to 8 Weeks and End of Treatment Interleukin 6 (IL6)	0.4 pg/mL Interval -0.04 to 1.8	0.3 pg/mL Interval -0.3 to 1.1	0.6 pg/mL Interval -0.3 to 5.8	—	—	—	—
Change in Cytokines From Baseline to 4 Weeks, Baseline to 8 Weeks and End of Treatment Interleukin 8 (IL8)	71.9 pg/mL Interval 5.3 to 163.1	64.8 pg/mL Interval -0.2 to 233.1	47.5 pg/mL Interval -9.1 to 121.1	—	—	—	—
Change in Cytokines From Baseline to 4 Weeks, Baseline to 8 Weeks and End of Treatment Interleukin 10 (IL10)	0.1 pg/mL Interval -0.1 to 1.4	-0.03 pg/mL Interval -0.2 to 0.4	-0.05 pg/mL Interval -0.3 to 0.2	—	—	—	—
Change in Cytokines From Baseline to 4 Weeks, Baseline to 8 Weeks and End of Treatment Interleukin 12 (IL12)	0.02 pg/mL Interval -0.08 to 0.09	0.00 pg/mL Interval -0.07 to 0.09	0.03 pg/mL Interval -0.07 to 0.14	—	—	—	—
Change in Cytokines From Baseline to 4 Weeks, Baseline to 8 Weeks and End of Treatment Interleukin 13 (IL13)	0.7 pg/mL Interval 0.03 to 1.9	0.9 pg/mL Interval 0.0 to 1.7	0.6 pg/mL Interval -0.02 to 1.3	—	—	—	—
Change in Cytokines From Baseline to 4 Weeks, Baseline to 8 Weeks and End of Treatment Tumor necrosis factor alpha (TNFα)	0.3 pg/mL Interval -0.09 to 0.8	0.5 pg/mL Interval 0.1 to 0.8	0.06 pg/mL Interval -0.3 to 0.4	—	—	—	—
Change in Cytokines From Baseline to 4 Weeks, Baseline to 8 Weeks and End of Treatment Interferon (IFN)-inducible protein 10 (IP-10)	76.5 pg/mL Interval -214.5 to 239.3	18.4 pg/mL Interval -271.7 to 216.6	-73.3 pg/mL Interval -335.7 to 127.8	—	—	—	—

SECONDARY outcome

Timeframe: Baseline to 4 weeks, baseline to 8 weeks, and baseline to end of treatment

Population: HIV+ participants = 18.

Fluorescence activated cell sorting.

Outcome measures

Measure	Grade 1 n=28 Participants Grade 1 is mild.	Grade 2 n=28 Participants Grade 2 is moderate.	Grade 3 n=28 Participants Grade 3 is severe.	Grade 4 Grade 4 is life-threatening.	Quite a Bit Response on the HRQL questionnaire.	Very Much Response on the HRQL questionnaire.	Somewhat or MoreϮ Response on the HRQL questionnaire.
Change in Immune Cytokines Cluster of Differentiation 4 (CD4), Cluster of Differentiation 8 (CD8) and Cluster of Differentiation 19 (CD19) Among Participants With and/or Without Human Immunodeficiency Virus (HIV) CD4+/All participants	66.5 cells/µL Interval -77.5 to 221.0	37 cells/µL Interval -57.0 to 176.0	-54 cells/µL Interval -178.5 to 91.5	—	—	—	—
Change in Immune Cytokines Cluster of Differentiation 4 (CD4), Cluster of Differentiation 8 (CD8) and Cluster of Differentiation 19 (CD19) Among Participants With and/or Without Human Immunodeficiency Virus (HIV) CD4+ among HIV+ participants	72 cells/µL Interval -29.0 to 257.0	37 cells/µL Interval -15.0 to 291.0	-14 cells/µL Interval -79.0 to 132.0	—	—	—	—
Change in Immune Cytokines Cluster of Differentiation 4 (CD4), Cluster of Differentiation 8 (CD8) and Cluster of Differentiation 19 (CD19) Among Participants With and/or Without Human Immunodeficiency Virus (HIV) CD8+/All participants	104.5 cells/µL Interval -76.5 to 257.0	115 cells/µL Interval -19.0 to 288.0	73 cells/µL Interval -38.5 to 194.5	—	—	—	—
Change in Immune Cytokines Cluster of Differentiation 4 (CD4), Cluster of Differentiation 8 (CD8) and Cluster of Differentiation 19 (CD19) Among Participants With and/or Without Human Immunodeficiency Virus (HIV) CD8+ among HIV+ participants	198 cells/µL Interval -20.0 to 414.0	129 cells/µL Interval 1.0 to 430.0	75 cells/µL Interval -102.0 to 295.0	—	—	—	—
Change in Immune Cytokines Cluster of Differentiation 4 (CD4), Cluster of Differentiation 8 (CD8) and Cluster of Differentiation 19 (CD19) Among Participants With and/or Without Human Immunodeficiency Virus (HIV) CD19+/All participants	-40 cells/µL Interval -73.0 to -3.5	-55 cells/µL Interval -123.0 to 5.0	-75 cells/µL Interval -124.5 to -49.5	—	—	—	—

SECONDARY outcome

Timeframe: Baseline to 4 weeks, baseline to 8 weeks and baseline to end of treatment

Population: PBMC = peripheral mononuclear cells

KSHV viral load in peripheral blood mononuclear cells was assessed by modifying a sandwich enzyme-linked immunosorbent assay (ELISA). Viral load testing may provide useful information on the occurrence of KSHV replication. Undetectable levels is good.

Outcome measures

Measure	Grade 1 n=28 Participants Grade 1 is mild.	Grade 2 n=28 Participants Grade 2 is moderate.	Grade 3 n=28 Participants Grade 3 is severe.	Grade 4 Grade 4 is life-threatening.	Quite a Bit Response on the HRQL questionnaire.	Very Much Response on the HRQL questionnaire.	Somewhat or MoreϮ Response on the HRQL questionnaire.
Change Between Timepoints Baseline to 4 Weeks, Baseline to 8 Weeks, and Baseline to End of Treatment in Kaposi Sarcoma-Associated Herpesvirus (KSHV) Viral Load	0 copies per million PBMC Interval 0.0 to 136.0	0 copies per million PBMC Interval 0.0 to 0.0	0 copies per million PBMC Interval 0.0 to 0.0	—	—	—	—

SECONDARY outcome

Timeframe: Baseline to 4 weeks, baseline to 8 weeks and baseline to end of treatment

HIV viral load in peripheral blood mononuclear cells was assessed by quantitative real-time polymerase chain reaction (PCR). The lower limit of detection for HIV viral load is <50 copies mL.

Outcome measures

Measure	Grade 1 n=28 Participants Grade 1 is mild.	Grade 2 n=28 Participants Grade 2 is moderate.	Grade 3 n=28 Participants Grade 3 is severe.	Grade 4 Grade 4 is life-threatening.	Quite a Bit Response on the HRQL questionnaire.	Very Much Response on the HRQL questionnaire.	Somewhat or MoreϮ Response on the HRQL questionnaire.
Human Immunodeficiency Virus (HIV) Viral Load	0 Copies/mL Interval 0.0 to 0.0	0 Copies/mL Interval 0.0 to 0.0	0 Copies/mL Interval 0.0 to 0.0	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, timepoint 1: after 3 months of therapy, and timepoint 2: 1 month after completion of therapy

Population: 22 participants were analyzed at baseline. 19/22 participants were evaluable and analyzed at timepoint 2 and timepoint 3 because the QOL data was not collected on the other 3 participants at those timepoints. Baseline n=22, timepoint 2 = 19, and timepoint 3 = 19. \*Sum of two preceding columns. ϮSum of three preceding columns.

The percentage of participants responding to each question with the indicated responses is shown. Changes in quality of life in participants receiving pomalidomide. HRQL was analyzed using a mixed-model repeated-measures analysis and the marginal homogeneity test for Kaposi sarcoma-specific questions. Three supplemental questions addressing pain, swelling, and satisfaction with physical appearance was used to collect quality of life data.

Outcome measures

Measure	Grade 1 n=22 Participants Grade 1 is mild.	Grade 2 n=22 Participants Grade 2 is moderate.	Grade 3 n=22 Participants Grade 3 is severe.	Grade 4 n=22 Participants Grade 4 is life-threatening.	Quite a Bit n=22 Participants Response on the HRQL questionnaire.	Very Much n=22 Participants Response on the HRQL questionnaire.	Somewhat or MoreϮ n=22 Participants Response on the HRQL questionnaire.
Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions Pain has interfered with my normal work or activities at baseline	45.5 percentage of participants	13.6 percentage of participants	59.1 percentage of participants	9.1 percentage of participants	22.7 percentage of participants	9.1 percentage of participants	40.9 percentage of participants
Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions Pain has interfered with my normal work or activities - timepoint 2: after 3 months of therapy	36.8 percentage of participants	26.3 percentage of participants	63.2 percentage of participants	26.3 percentage of participants	5.3 percentage of participants	5.3 percentage of participants	36.8 percentage of participants
Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions Pain has interfered with my normal work or activities timepoint 3:1month after completion of therapy	36.8 percentage of participants	26.3 percentage of participants	63.2 percentage of participants	21.1 percentage of participants	5.3 percentage of participants	10.5 percentage of participants	36.8 percentage of participants
Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions I am satisfied with my physical appearance at baseline	27.3 percentage of participants	27.3 percentage of participants	54.6 percentage of participants	27.3 percentage of participants	13.6 percentage of participants	4.5 percentage of participants	45.4 percentage of participants
Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions I am satisfied with my physical appearance - timepoint 2: after 3 months of therapy	31.6 percentage of participants	4.5 percentage of participants	36.8 percentage of participants	26.3 percentage of participants	26.3 percentage of participants	10.5 percentage of participants	63.2 percentage of participants
Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions I am satisfied with my physical appearance - timepoint 3: 1 month after completion of therapy	15.8 percentage of participants	10.5 percentage of participants	26.3 percentage of participants	26.3 percentage of participants	42.1 percentage of participants	5.3 percentage of participants	73.7 percentage of participants
Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions I have had swelling in my face, arms, or legs at baseline	27.3 percentage of participants	9.1 percentage of participants	36 percentage of participants	22.7 percentage of participants	18.2 percentage of participants	22.7 percentage of participants	63.6 percentage of participants
Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions I have had swelling in my face, arms, or legs - timepoint 2: after 3 months of therapy	36.8 percentage of participants	10.5 percentage of participants	47 percentage of participants	21.1 percentage of participants	21.1 percentage of participants	10.5 percentage of participants	52.6 percentage of participants
Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions I have had swelling in my face, arms, or legs - timepoint 3: 1 month after completion of therapy	31.6 percentage of participants	15.8 percentage of participants	47 percentage of participants	21.1 percentage of participants	26.3 percentage of participants	5.3 percentage of participants	52.6 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Date treatment consent signed to date off study, approximately 124 months and 1 day.

Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Outcome measures

Measure	Grade 1 n=28 Participants Grade 1 is mild.	Grade 2 Grade 2 is moderate.	Grade 3 Grade 3 is severe.	Grade 4 Grade 4 is life-threatening.	Quite a Bit Response on the HRQL questionnaire.	Very Much Response on the HRQL questionnaire.	Somewhat or MoreϮ Response on the HRQL questionnaire.
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)	28 Participants	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: First 8 weeks (2 cycles) of drug administration

A dose limiting toxicity is any grade 4 toxicity not including lymphopenia, cluster of differentiation 4 (CD4) lymphopenia, neutropenia, anemia and bilirubin or creatine kinase (CK) elevation that is at least possibly due to pomalidomide and is not attributable to human immunodeficiency virus (HIV), its therapy or Kaposi Sarcoma (KS). Any grade 3 toxicity that is at least possibly due to pomalidomide and is not attributable to HIV, its therapy, or KS and restrictions such as grade 3 thrombocytopenia if grade 3 for 14 days or more, Grade 3 asymptomatic hyperuricemia or hypophosphatemia, or Grade 3 amylase elevations.

Any arterial or deep venous thromboembolic event or a second superficial thromboembolic event that is at least possibly due to pomalidomide. Inability to deliver pomalidomide on at least 50% of scheduled days during the first two cycles of therapy as a result of toxicity that is probably or definitely attributable to pomalidomide.

Outcome measures

Measure	Grade 1 n=28 Participants Grade 1 is mild.	Grade 2 Grade 2 is moderate.	Grade 3 Grade 3 is severe.	Grade 4 Grade 4 is life-threatening.	Quite a Bit Response on the HRQL questionnaire.	Very Much Response on the HRQL questionnaire.	Somewhat or MoreϮ Response on the HRQL questionnaire.
Number of Dose-limiting Toxicities	0 toxicities	—	—	—	—	—	—

Adverse Events

Pomalidomide 5mg Daily

Serious events: 12 serious events

Other events: 28 other events

Deaths: 4 deaths

Serious adverse events

Measure	Pomalidomide 5mg Daily n=28 participants at risk All participants treated with pomalidomide 5 mg by mouth (p.o.) for 21 of 28 days.
Blood and lymphatic system disorders Anemia	7.1% 2/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Investigations Blood bilirubin increased	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Investigations Creatinine increased	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
General disorders Death Not otherwise specified (NOS)	14.3% 4/28 • Number of events 4 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Gastrointestinal disorders Diarrhea	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Nervous system disorders Dizziness	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Respiratory, thoracic and mediastinal disorders Dyspnea	7.1% 2/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
General disorders Edema limbs	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Infections and infestations Enterocolitis infectious	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
General disorders Fatigue	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Blood and lymphatic system disorders Febrile neutropenia	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
General disorders Fever	7.1% 2/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Gastrointestinal disorders Gastrointestinal disorders - Other, gastrointestinal (GI) bleed	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Renal and urinary disorders Hematuria	3.6% 1/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Metabolism and nutrition disorders Hypoalbuminemia	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Vascular disorders Hypotension	7.1% 2/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Gastrointestinal disorders Nausea	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Anal cancer	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Bladder tumor	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Hodgkin's lymphoma	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Non-Hodgkin's Lymphoma	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Investigations Neutrophil count decreased	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
General disorders Pain	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Investigations Platelet count decreased	7.1% 2/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Skin and subcutaneous tissue disorders Rash maculo-papular	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Renal and urinary disorders Urinary retention	3.6% 1/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Vascular disorders Vasculitis	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Investigations White blood cell decreased	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.

Other adverse events

Measure	Pomalidomide 5mg Daily n=28 participants at risk All participants treated with pomalidomide 5 mg by mouth (p.o.) for 21 of 28 days.
Gastrointestinal disorders Abdominal pain	7.1% 2/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Investigations Activated partial thromboplastin time prolonged	25.0% 7/28 • Number of events 9 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Investigations Alanine aminotransferase increased	57.1% 16/28 • Number of events 47 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Investigations Alkaline phosphatase increased	17.9% 5/28 • Number of events 12 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	7.1% 2/28 • Number of events 3 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Skin and subcutaneous tissue disorders Alopecia	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Investigations Amylase	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Gastrointestinal disorders Anal hemorrhage	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Blood and lymphatic system disorders Anemia	78.6% 22/28 • Number of events 61 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Metabolism and nutrition disorders Anorexia	10.7% 3/28 • Number of events 5 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Psychiatric disorders Anxiety	14.3% 4/28 • Number of events 4 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Musculoskeletal and connective tissue disorders Arthralgia	17.9% 5/28 • Number of events 7 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Musculoskeletal and connective tissue disorders Arthritis	7.1% 2/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Investigations Aspartate aminotransferase increased	42.9% 12/28 • Number of events 35 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Musculoskeletal and connective tissue disorders Back pain	10.7% 3/28 • Number of events 3 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Investigations Blood bilirubin increased	14.3% 4/28 • Number of events 6 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Eye disorders Blurred vision	7.1% 2/28 • Number of events 4 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Musculoskeletal and connective tissue disorders Bone pain	21.4% 6/28 • Number of events 13 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Respiratory, thoracic and mediastinal disorders Bronchospasm	3.6% 1/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Injury, poisoning and procedural complications Bruising	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Injury, poisoning and procedural complications Burn	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Musculoskeletal and connective tissue disorders Buttock pain	3.6% 1/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Investigations Cluster of differentiation (CD4) lymphocytes decreased	42.9% 12/28 • Number of events 33 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Investigations Creatine phosphokinase (CPK) increased	28.6% 8/28 • Number of events 28 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Cardiac disorders Chest pain - cardiac	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
General disorders Chills	17.9% 5/28 • Number of events 5 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Nervous system disorders Concentration impairment	10.7% 3/28 • Number of events 7 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Eye disorders Conjunctivitis	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Gastrointestinal disorders Constipation	75.0% 21/28 • Number of events 36 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Respiratory, thoracic and mediastinal disorders Cough	32.1% 9/28 • Number of events 10 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Investigations Creatinine increased	35.7% 10/28 • Number of events 24 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Gastrointestinal disorders Dental caries	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Psychiatric disorders Depression	10.7% 3/28 • Number of events 4 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Gastrointestinal disorders Diarrhea	32.1% 9/28 • Number of events 21 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Nervous system disorders Dizziness	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Eye disorders Dry eye	7.1% 2/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Skin and subcutaneous tissue disorders Dry skin	21.4% 6/28 • Number of events 8 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Nervous system disorders Dysgeusia	7.1% 2/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Gastrointestinal disorders Dyspepsia	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Gastrointestinal disorders Dysphagia	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Respiratory, thoracic and mediastinal disorders Dyspnea	32.1% 9/28 • Number of events 12 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
General disorders Edema face	3.6% 1/28 • Number of events 3 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
General disorders Edema limbs	50.0% 14/28 • Number of events 26 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
General disorders Edema trunk	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Infections and infestations Enterocolitis	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Respiratory, thoracic and mediastinal disorders Epistaxis	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Eye disorders Eye disorders - Other, Blepharitis	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Eye disorders Eye disorders - Other, excessive wetness	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Eye disorders Eye disorders - Other, left eye nodule	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Injury, poisoning and procedural complications Fall	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
General disorders Fatigue	64.3% 18/28 • Number of events 54 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
General disorders Fever	17.9% 5/28 • Number of events 7 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Gastrointestinal disorders Flatulence	7.1% 2/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
General disorders Flu like symptoms	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Vascular disorders Flushing	7.1% 2/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Gastrointestinal disorders Gastritis	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Gastrointestinal disorders Gastrointestinal disorders - Other, gastrointestinal (GI) distress	3.6% 1/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Gastrointestinal disorders Gastrointestinal disorders - Other, abdominal cramping	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
General disorders General disorders and administration site conditions - Other, Cramps in Lower extremities and arms	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
General disorders General disorders and administration site conditions - Other, Decreased appetite	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
General disorders General disorders and administration site conditions - Other, Imbalance due to Hip Pain	3.6% 1/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
General disorders General disorders and administration site conditions - Other, Night Sweats	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Infections and infestations Gum infection	7.1% 2/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Nervous system disorders Headache	14.3% 4/28 • Number of events 5 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Renal and urinary disorders Hematuria	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Skin and subcutaneous tissue disorders Hives	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Vascular disorders Hot flashes	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Metabolism and nutrition disorders Hypercalcemia	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Metabolism and nutrition disorders Hyperglycemia	39.3% 11/28 • Number of events 15 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Skin and subcutaneous tissue disorders Hyperhidrosis	10.7% 3/28 • Number of events 3 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Metabolism and nutrition disorders Hyperkalemia	7.1% 2/28 • Number of events 3 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Metabolism and nutrition disorders Hypermagnesemia	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Metabolism and nutrition disorders Hypernatremia	21.4% 6/28 • Number of events 7 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Vascular disorders Hypertension	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Metabolism and nutrition disorders Hypertriglyceridemia	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Metabolism and nutrition disorders Hyperuricemia	10.7% 3/28 • Number of events 7 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Metabolism and nutrition disorders Hypoalbuminemia	60.7% 17/28 • Number of events 44 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Metabolism and nutrition disorders Hypocalcemia	39.3% 11/28 • Number of events 14 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Metabolism and nutrition disorders Hypoglycemia	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Metabolism and nutrition disorders Hypokalemia	10.7% 3/28 • Number of events 11 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Metabolism and nutrition disorders Hypomagnesemia	25.0% 7/28 • Number of events 10 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Metabolism and nutrition disorders Hyponatremia	28.6% 8/28 • Number of events 10 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Metabolism and nutrition disorders Hypophosphatemia	75.0% 21/28 • Number of events 83 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Endocrine disorders Hypothyroidism	25.0% 7/28 • Number of events 9 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Investigations International normalized ratio (INR) increased	3.6% 1/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Immune system disorders Immune system disorders - Other, insect bite reaction	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Immune system disorders Immune system disorders - Other, prominent insect bite	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Infections and infestations Infections and infestations - Other, Cellulitis	7.1% 2/28 • Number of events 3 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Infections and infestations Infections and infestations - Other, Left foot soft tissue infection	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Infections and infestations Infections and infestations - Other, Perianal infection	3.6% 1/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Infections and infestations Infections and infestations - Other, left leg infection	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Infections and infestations Infections and infestations - Other, possible URI	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Infections and infestations Infections and infestations - Other, right leg cellulitis	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Psychiatric disorders Insomnia	10.7% 3/28 • Number of events 3 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
General disorders Irritability	17.9% 5/28 • Number of events 6 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Psychiatric disorders Libido decreased	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Nervous system disorders Lightheadedness	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Investigations Lipase increased	14.3% 4/28 • Number of events 7 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
General disorders Localized edema	3.6% 1/28 • Number of events 3 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Infections and infestations Lung infection	10.7% 3/28 • Number of events 4 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Investigations Lymphocyte count decreased	53.6% 15/28 • Number of events 64 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
General disorders Malaise	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Nervous system disorders Memory impairment	7.1% 2/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Musculoskeletal and connective tissue disorders Muscle cramps	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Musculoskeletal and connective tissue disorders Muscle weakness upper limb	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, Muscle Spasm Legs	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, muscle spasm (legs)	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Musculoskeletal and connective tissue disorders Myalgia	14.3% 4/28 • Number of events 8 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Skin and subcutaneous tissue disorders Nail discoloration	7.1% 2/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Respiratory, thoracic and mediastinal disorders Nasal congestion	25.0% 7/28 • Number of events 8 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Gastrointestinal disorders Nausea	39.3% 11/28 • Number of events 15 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Musculoskeletal and connective tissue disorders Neck pain	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Nervous system disorders Nervous system disorders - Other, Neuropathy hands	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Nervous system disorders Nervous system disorders - Other, Neuropathy toes	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Nervous system disorders Nervous system disorders - Other, Spinal stenosis	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Nervous system disorders Nervous system disorders - Other, intermittent dragging of R foot	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Investigations Neutrophil count decreased	96.4% 27/28 • Number of events 165 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Skin and subcutaneous tissue disorders Night sweat	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Skin and subcutaneous tissue disorders Night sweats	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Renal and urinary disorders Nocturia	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Musculoskeletal and connective tissue disorders Non-cardiac chest pain	10.7% 3/28 • Number of events 3 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
General disorders Pain	46.4% 13/28 • Number of events 33 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Musculoskeletal and connective tissue disorders Pain in extremity	28.6% 8/28 • Number of events 13 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Reproductive system and breast disorders Pelvic pain	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Skin and subcutaneous tissue disorders Periorbital edema	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Nervous system disorders Peripheral motor neuropathy	3.6% 1/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Nervous system disorders Peripheral sensory neuropathy	25.0% 7/28 • Number of events 9 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Infections and infestations Pharyngitis	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Eye disorders Photophobia	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Investigations Platelet count decreased	64.3% 18/28 • Number of events 53 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Respiratory, thoracic and mediastinal disorders Pleural effusion	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Renal and urinary disorders Proteinuria	17.9% 5/28 • Number of events 8 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Skin and subcutaneous tissue disorders Pruritus	10.7% 3/28 • Number of events 7 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Skin and subcutaneous tissue disorders Rash acneiform	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Skin and subcutaneous tissue disorders Rash maculo-papular	71.4% 20/28 • Number of events 53 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Renal and urinary disorders Renal and urinary disorders - Other, Nocturia	3.6% 1/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, Nasal Congestion	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, Rhinorrhea	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, Runny nose	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, a URI rhinorrhea x3 days	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, a URI w/ congestion and rhinorrhea x3 days	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Respiratory, thoracic and mediastinal disorders Runny nose	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Investigations Serum amylase increased	14.3% 4/28 • Number of events 9 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
General disorders Shivering	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Respiratory, thoracic and mediastinal disorders Sinus disorder	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Infections and infestations Sinusitis	3.6% 1/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Right leg cellulitis	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, hand foot syndrome	3.6% 1/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, skin discoloration	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, warts on the left 2nd toe	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	7.1% 2/28 • Number of events 4 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Skin and subcutaneous tissue disorders Skin induration	7.1% 2/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Infections and infestations Skin infection	21.4% 6/28 • Number of events 8 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Respiratory, thoracic and mediastinal disorders Sneezing	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Infections and infestations Soft tissue infection	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Respiratory, thoracic and mediastinal disorders Sore throat	7.1% 2/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Injury, poisoning and procedural complications Stomal ulcer	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Infections and infestations Tooth infection	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Gastrointestinal disorders Toothache	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Nervous system disorders Tremor	7.1% 2/28 • Number of events 4 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	10.7% 3/28 • Number of events 4 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Infections and infestations Upper respiratory infection	28.6% 8/28 • Number of events 9 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Renal and urinary disorders Urinary retention	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Ear and labyrinth disorders Vertigo	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Gastrointestinal disorders Vomiting	10.7% 3/28 • Number of events 3 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Investigations Weight gain	21.4% 6/28 • Number of events 6 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Investigations Weight loss	7.1% 2/28 • Number of events 2 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Respiratory, thoracic and mediastinal disorders Wheezing	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Investigations White blood cell decreased	78.6% 22/28 • Number of events 100 • Date treatment consent signed to date off study, approximately 124 months and 1 day.
Injury, poisoning and procedural complications Wrist fracture	3.6% 1/28 • Number of events 1 • Date treatment consent signed to date off study, approximately 124 months and 1 day.

Additional Information

Dr. Robert Yarchoan

National Cancer Institute

Phone: 240-760-6075

Email: robert.yarchoan@nih.gov

Results disclosure agreements

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