Trial Outcomes & Findings for The Effect of Vorinostat on HIV RNA Expression in the Resting CD4+ T Cells of HIV+ Pts on Stable ART (NCT NCT01319383)
NCT ID: NCT01319383
Last Updated: 2017-06-29
Results Overview
Participants in Arm 1 and 2 were analyzed in Step 2 for an in vivo increase in resting CD4+ T cell- associated HIV RNA (RCVL) after administration of a single dose of VOR 400 mg PO
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
25 participants
Primary outcome timeframe
Arm1: Baseline, Visit 5 and Arm 2: Baseline and Visit 3
Results posted on
2017-06-29
Participant Flow
Potential HIV infected participants who were durably suppressed (\<50 copies/mL) on stable ART with a CD4 count \>300/μL were recruited from the UNC ID clinic and UNC AIDS Clinical Trials Unit. Twenty seven (27) participants were screened for both study periods, 25 unique individuals enrolled between February 2011 and March 31, 2016.
Participants were recruited into the single and multiple dose Vorinostat (VOR) Arm alone, the VOR Interval Dosing Arm alone, or both = 25. Each Arm had multiple steps. Participants without a significant in vitro or in vivo response to VOR did not advance in either Arm; 3 Arm 1 and 13 new participants, enrolled Arm 2.
Participant milestones
| Measure |
Single and Multiple Dose
There are 3 Steps in this Arm: Step 1 a Baseline leukapheresis was completed to obtain resting CD4+ T cells for quantitation of resting CD4+ T cell infection (RCI) and resting CD4+ T cell- associated HIV RNA (RCVL); ex-vivo exposure. Step 2 measured the in-vivo response to single dose of VOR; Step 3 measured the in vivo response after each of 2 series of exposure to multiple doses of VOR 400 mg PO. In each series, 11 doses of VOR were administered for 3 days (M-T-W) and no doses for the remaining 4 days. A leukapheresis was completed 4 hours after the 11th dose to measure in vivo response.
|
Interval Dosing
There are 4 steps in this Arm. Step 1 Baseline leukapheresis (Visit 2) to obtain resting CD4+ T cells for quantitation of resting CD4+ T cell infection (RCI) and resting CD4+ T cell- associated HIV RNA (RCVL). Ex-vivo exposure to measure RCVL responsiveness to Vorinostat. Step 2 involved measurement of in vivo response to single dose of VOR. Step 3 involved 2 doses separated by 48 or 72 hours. In vivo responsiveness measured for optimal dose interval and step advancement. Step 4 measured significance of response to VOR 400 mg PO taken every 72 hours for 10 doses.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
13
|
|
Overall Study
Step 1
|
8
|
11
|
|
Overall Study
Step 2
|
4
|
0
|
|
Overall Study
Step 3
|
0
|
6
|
|
Overall Study
Step 4
|
0
|
3
|
|
Overall Study
COMPLETED
|
0
|
3
|
|
Overall Study
NOT COMPLETED
|
12
|
10
|
Reasons for withdrawal
| Measure |
Single and Multiple Dose
There are 3 Steps in this Arm: Step 1 a Baseline leukapheresis was completed to obtain resting CD4+ T cells for quantitation of resting CD4+ T cell infection (RCI) and resting CD4+ T cell- associated HIV RNA (RCVL); ex-vivo exposure. Step 2 measured the in-vivo response to single dose of VOR; Step 3 measured the in vivo response after each of 2 series of exposure to multiple doses of VOR 400 mg PO. In each series, 11 doses of VOR were administered for 3 days (M-T-W) and no doses for the remaining 4 days. A leukapheresis was completed 4 hours after the 11th dose to measure in vivo response.
|
Interval Dosing
There are 4 steps in this Arm. Step 1 Baseline leukapheresis (Visit 2) to obtain resting CD4+ T cells for quantitation of resting CD4+ T cell infection (RCI) and resting CD4+ T cell- associated HIV RNA (RCVL). Ex-vivo exposure to measure RCVL responsiveness to Vorinostat. Step 2 involved measurement of in vivo response to single dose of VOR. Step 3 involved 2 doses separated by 48 or 72 hours. In vivo responsiveness measured for optimal dose interval and step advancement. Step 4 measured significance of response to VOR 400 mg PO taken every 72 hours for 10 doses.
|
|---|---|---|
|
Overall Study
No ex vivo or in vivo response
|
4
|
0
|
|
Overall Study
Physician Decision
|
3
|
0
|
|
Overall Study
Lack of Efficacy
|
5
|
9
|
|
Overall Study
No in vivo response to interval doses
|
0
|
1
|
Baseline Characteristics
The Effect of Vorinostat on HIV RNA Expression in the Resting CD4+ T Cells of HIV+ Pts on Stable ART
Baseline characteristics by cohort
| Measure |
Single, Multiple and Interval Dosing Of Vorinostat 400 mg PO
n=25 Participants
The study was separated into Arms for reporting purposes required in this report. The data representing the eligibility and baseline measures were the same throughout the study and are therefore reported as a composite of the entire study. Vorinostat 400 mg PO was administered in single and multiple doses in both Arm 1 and 2. The entire cohort is described below and representative of all who were enrolled in the study over the 5 year period.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
49 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian or White
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
|
HIV-1 RNA Categories
< 50 copies/mL
|
25 Participants
n=5 Participants
|
|
HIV-1 RNA Categories
>= 50 copies/mL
|
0 Participants
n=5 Participants
|
|
CD4 Nadir
|
403 cells/µL
n=5 Participants
|
|
CD4 Cell Count
|
718 cells/µL
n=5 Participants
|
PRIMARY outcome
Timeframe: Arm1: Baseline, Visit 5 and Arm 2: Baseline and Visit 3Participants in Arm 1 and 2 were analyzed in Step 2 for an in vivo increase in resting CD4+ T cell- associated HIV RNA (RCVL) after administration of a single dose of VOR 400 mg PO
Outcome measures
| Measure |
1/Single & Multiple Dose, Step 2, Visit 5
n=12 Participants
Participants enrolled in Arm 1 were given one dose of VOR 200 mg by mouth (PO), symptoms were assessed over 12 hours and pharmacokinetic samples obtained. Leukapheresis procedure was performed 4 hours after the dose to measure RCVL in-vivo response.
|
2/Interval Dosing, Visit 3
n=11 Participants
Participants enrolled in Arm 2 receiving a single dose of VOR 400 mg PO after demonstrating an ex vivo response at baseline. Symptoms were assessed over 12 hours and pharmacokinetic samples obtained. Leukapheresis procedure was performed 4 hours after the dose to measure RCVL in-vivo response.
|
|---|---|---|
|
Number of Participants Exhibiting an in Vivo Resting CD4+ T Cell- Associated HIV RNA (RCVL) Increase After Receiving a Single Dose of VOR 400 mg PO
|
8 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Visit 18, Visit 29Population: Participants with resting CD4+ T-cell-associated HIV RNA (rc-RNA) increases after receiving daily VOR Monday through Wednesday for 8 weekly cycles were enrolled.
Participants in Arm 1, Step 3 were analyzed for an in vivo increase in the resting CD4+ T cell- associated HIV RNA (RCVL) after 11 doses of VOR 400 mg PO. This cycle was repeated after a 5 - 8 week rest period for a 2nd series and measurement.
Outcome measures
| Measure |
1/Single & Multiple Dose, Step 2, Visit 5
n=5 Participants
Participants enrolled in Arm 1 were given one dose of VOR 200 mg by mouth (PO), symptoms were assessed over 12 hours and pharmacokinetic samples obtained. Leukapheresis procedure was performed 4 hours after the dose to measure RCVL in-vivo response.
|
2/Interval Dosing, Visit 3
Participants enrolled in Arm 2 receiving a single dose of VOR 400 mg PO after demonstrating an ex vivo response at baseline. Symptoms were assessed over 12 hours and pharmacokinetic samples obtained. Leukapheresis procedure was performed 4 hours after the dose to measure RCVL in-vivo response.
|
|---|---|---|
|
Number of Participants Exhibiting an in Vivo Resting CD4+ T-cell-associated HIV RNA (Rc-RNA) Increase Following Each of Two Multiple Dose Cycles (11 Doses/Cycle)
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Baseline, Visit 6Population: Participants showing an in vivo response in resting CD4+ T cell- associated HIV RNA (RCVL) after a single dose of VOR were administered 2 doses of VOR 400 mg separated by either 48 or 72 hours to determine the optimal interval/spacing to observe a significant in vivo response in the RCVL after the paired doses.
Induction of significant in vivo RCI and RCLV response after 2 doses of VOR 400 mg PO administered 48 hours apart or 72 hours apart
Outcome measures
| Measure |
1/Single & Multiple Dose, Step 2, Visit 5
n=1 Participants
Participants enrolled in Arm 1 were given one dose of VOR 200 mg by mouth (PO), symptoms were assessed over 12 hours and pharmacokinetic samples obtained. Leukapheresis procedure was performed 4 hours after the dose to measure RCVL in-vivo response.
|
2/Interval Dosing, Visit 3
n=7 Participants
Participants enrolled in Arm 2 receiving a single dose of VOR 400 mg PO after demonstrating an ex vivo response at baseline. Symptoms were assessed over 12 hours and pharmacokinetic samples obtained. Leukapheresis procedure was performed 4 hours after the dose to measure RCVL in-vivo response.
|
|---|---|---|
|
Number of Participants With a Significant in Vivo Response in Resting Cell Infection (RCI) and HIV RNA After Paired Doses
|
0 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Baseline, Visit 9Population: Participants who demonstrated a significant in vivo response after taking 2 doses of VOR 400 mg PO, each dose taken 72 hours apart were administered 10 doses of VOR based on the optimal dosing of 72 hours.
Participants in Arm 2, Step 4 were analyzed for an in vivo increase in the resting CD4+ T cell- associated HIV RNA (RCVL) after administration of 10 doses of VOR 400 mg PO, given 72 hours apart.
Outcome measures
| Measure |
1/Single & Multiple Dose, Step 2, Visit 5
n=3 Participants
Participants enrolled in Arm 1 were given one dose of VOR 200 mg by mouth (PO), symptoms were assessed over 12 hours and pharmacokinetic samples obtained. Leukapheresis procedure was performed 4 hours after the dose to measure RCVL in-vivo response.
|
2/Interval Dosing, Visit 3
Participants enrolled in Arm 2 receiving a single dose of VOR 400 mg PO after demonstrating an ex vivo response at baseline. Symptoms were assessed over 12 hours and pharmacokinetic samples obtained. Leukapheresis procedure was performed 4 hours after the dose to measure RCVL in-vivo response.
|
|---|---|---|
|
Number of Participants Exhibiting an in Vivo Resting CD4+ T-cell-associated HIV RNA (Rc-RNA) Increase Following Multiple (n = 10) Interval Doses
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: 1 week after last VOR dosePopulation: All participants receiving one or more doses of VOR in any and all Arms of the study.
Assess for detectible HIV-1 RNA \> 150 copies/mL, confirmed by repeat evaluation, following VOR dose. By standard assay and single copy assay. Pre specified to combine all participants into one arm.
Outcome measures
| Measure |
1/Single & Multiple Dose, Step 2, Visit 5
n=12 Participants
Participants enrolled in Arm 1 were given one dose of VOR 200 mg by mouth (PO), symptoms were assessed over 12 hours and pharmacokinetic samples obtained. Leukapheresis procedure was performed 4 hours after the dose to measure RCVL in-vivo response.
|
2/Interval Dosing, Visit 3
n=13 Participants
Participants enrolled in Arm 2 receiving a single dose of VOR 400 mg PO after demonstrating an ex vivo response at baseline. Symptoms were assessed over 12 hours and pharmacokinetic samples obtained. Leukapheresis procedure was performed 4 hours after the dose to measure RCVL in-vivo response.
|
|---|---|---|
|
Number of Participants With Measurable Changes in Plasma HIV-1 RNA
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 24 hrs following single dose and 1 week after last of multiple dose sequencePopulation: All participants receiving one or more doses of VOR 400 mg PO in any and all Arms of the study.
DAIDS Grading Table- Grade 1- mild, Grade 2- moderate; Grade 3- severe Grade 4- potentially life-threatening. Pre specified to combine all participants into one arm.
Outcome measures
| Measure |
1/Single & Multiple Dose, Step 2, Visit 5
n=12 Participants
Participants enrolled in Arm 1 were given one dose of VOR 200 mg by mouth (PO), symptoms were assessed over 12 hours and pharmacokinetic samples obtained. Leukapheresis procedure was performed 4 hours after the dose to measure RCVL in-vivo response.
|
2/Interval Dosing, Visit 3
n=13 Participants
Participants enrolled in Arm 2 receiving a single dose of VOR 400 mg PO after demonstrating an ex vivo response at baseline. Symptoms were assessed over 12 hours and pharmacokinetic samples obtained. Leukapheresis procedure was performed 4 hours after the dose to measure RCVL in-vivo response.
|
|---|---|---|
|
Number of Participants With Confirmed Non-hematologic Toxicity >/= Grade 3 and Related to VOR Per Division of AIDS (DAIDS) Grading Table
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 24 hrs following single dose and 1 week after last of multiple dose sequencePopulation: All participants receiving one or more doses of VOR 400 mg PO in any and all Arms of the study.
DAIDS Grading Table- Grade 1- mild, Grade 2- moderate; Grade 3- severe Grade 4- potentially life-threatening. Pre specified to combine all participants into one arm.
Outcome measures
| Measure |
1/Single & Multiple Dose, Step 2, Visit 5
n=12 Participants
Participants enrolled in Arm 1 were given one dose of VOR 200 mg by mouth (PO), symptoms were assessed over 12 hours and pharmacokinetic samples obtained. Leukapheresis procedure was performed 4 hours after the dose to measure RCVL in-vivo response.
|
2/Interval Dosing, Visit 3
n=13 Participants
Participants enrolled in Arm 2 receiving a single dose of VOR 400 mg PO after demonstrating an ex vivo response at baseline. Symptoms were assessed over 12 hours and pharmacokinetic samples obtained. Leukapheresis procedure was performed 4 hours after the dose to measure RCVL in-vivo response.
|
|---|---|---|
|
Number of Participants With Confirmed Hematologic Toxicity >/= Grade 2 and Related to VOR Per Division of AIDS (DAIDS) Grading Table
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From last dose Vorinostat to 5 years afterwardsPopulation: At end of study, participants receiving \>/= 8 doses of Vorinostat are enrolled in a 5-year cancer incidence database to be monitored for the occurrence of cancer.
Development of a new cancer within the 5 years of taking their last dose of VOR 400 mg PO.All participants receiving one or more doses of VOR 400 mg PO in any and all Arms of the study. Pre-specified to be reported as one group.
Outcome measures
| Measure |
1/Single & Multiple Dose, Step 2, Visit 5
n=5 Participants
Participants enrolled in Arm 1 were given one dose of VOR 200 mg by mouth (PO), symptoms were assessed over 12 hours and pharmacokinetic samples obtained. Leukapheresis procedure was performed 4 hours after the dose to measure RCVL in-vivo response.
|
2/Interval Dosing, Visit 3
n=3 Participants
Participants enrolled in Arm 2 receiving a single dose of VOR 400 mg PO after demonstrating an ex vivo response at baseline. Symptoms were assessed over 12 hours and pharmacokinetic samples obtained. Leukapheresis procedure was performed 4 hours after the dose to measure RCVL in-vivo response.
|
|---|---|---|
|
Number of Participants Developing Cancer Within 5 Years Following >/= 8 Vorinostat Dose Exposures
|
0 Participants
|
0 Participants
|
Adverse Events
Open Label - Translational Research Study
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Open Label - Translational Research Study
n=25 participants at risk
Period One: Step 1 (ex-vivo), Step 2 (single dose) and Step 3 (multiple dose). Advancement to each step required demonstration of significant HIV-1 RNA expression per 1 million RCVL response to VOR. Step 1: All participants had an ex-vivo exposure to VOR. Step 2: Participants with and without an ex-vivo response received 1 single dose VOR. Step 3: Participants demonstrating an in vivo response received multiple doses consisting of 2 series of 11 VOR doses each; with in vivo response measured after each series. Period One was stopped due to lack of significant in-vivo response to the multiple doses.
Period Two: Step 1, Step 2 and advancement criteria are the same as above. Step 3 (interval paired dose) and Step 4 (multiple interval doses). Participants without an ex-vivo response did not progress past Step 1. Step 3: Responders received 2 doses separated by 48 or 72 hours. Step 4: Responders then received 10 doses of VOR at pre-determined interval.
|
|---|---|
|
Gastrointestinal disorders
Abdominal Discomfort
|
4.0%
1/25 • Number of events 2 • Period One: February 1, 2011 through December 31, 2013. Period Two: January 1, 2014 through March 31, 2016.
Data were analyzed for all participants in one arm.
|
|
Gastrointestinal disorders
Abdominal Pain
|
4.0%
1/25 • Number of events 1 • Period One: February 1, 2011 through December 31, 2013. Period Two: January 1, 2014 through March 31, 2016.
Data were analyzed for all participants in one arm.
|
|
General disorders
Asthenia
|
4.0%
1/25 • Number of events 1 • Period One: February 1, 2011 through December 31, 2013. Period Two: January 1, 2014 through March 31, 2016.
Data were analyzed for all participants in one arm.
|
|
Investigations
Blood Albumin Decreased
|
8.0%
2/25 • Number of events 2 • Period One: February 1, 2011 through December 31, 2013. Period Two: January 1, 2014 through March 31, 2016.
Data were analyzed for all participants in one arm.
|
|
Investigations
Blood Calcium Decreased
|
4.0%
1/25 • Number of events 1 • Period One: February 1, 2011 through December 31, 2013. Period Two: January 1, 2014 through March 31, 2016.
Data were analyzed for all participants in one arm.
|
|
Investigations
Blood Calcium Increased
|
4.0%
1/25 • Number of events 1 • Period One: February 1, 2011 through December 31, 2013. Period Two: January 1, 2014 through March 31, 2016.
Data were analyzed for all participants in one arm.
|
|
Investigations
Blood Creatinine Increased
|
8.0%
2/25 • Number of events 3 • Period One: February 1, 2011 through December 31, 2013. Period Two: January 1, 2014 through March 31, 2016.
Data were analyzed for all participants in one arm.
|
|
Investigations
Blood Glucose Increased
|
36.0%
9/25 • Number of events 16 • Period One: February 1, 2011 through December 31, 2013. Period Two: January 1, 2014 through March 31, 2016.
Data were analyzed for all participants in one arm.
|
|
Investigations
Blood Potassium Decreased
|
12.0%
3/25 • Number of events 3 • Period One: February 1, 2011 through December 31, 2013. Period Two: January 1, 2014 through March 31, 2016.
Data were analyzed for all participants in one arm.
|
|
Investigations
Blood Sodium Increased
|
4.0%
1/25 • Number of events 1 • Period One: February 1, 2011 through December 31, 2013. Period Two: January 1, 2014 through March 31, 2016.
Data were analyzed for all participants in one arm.
|
|
Cardiac disorders
Bradycardia
|
4.0%
1/25 • Number of events 1 • Period One: February 1, 2011 through December 31, 2013. Period Two: January 1, 2014 through March 31, 2016.
Data were analyzed for all participants in one arm.
|
|
Gastrointestinal disorders
Constipation
|
8.0%
2/25 • Number of events 3 • Period One: February 1, 2011 through December 31, 2013. Period Two: January 1, 2014 through March 31, 2016.
Data were analyzed for all participants in one arm.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
8.0%
2/25 • Number of events 2 • Period One: February 1, 2011 through December 31, 2013. Period Two: January 1, 2014 through March 31, 2016.
Data were analyzed for all participants in one arm.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.0%
3/25 • Number of events 3 • Period One: February 1, 2011 through December 31, 2013. Period Two: January 1, 2014 through March 31, 2016.
Data were analyzed for all participants in one arm.
|
|
Nervous system disorders
Dizziness
|
24.0%
6/25 • Number of events 8 • Period One: February 1, 2011 through December 31, 2013. Period Two: January 1, 2014 through March 31, 2016.
Data were analyzed for all participants in one arm.
|
|
Nervous system disorders
Dizziness Postural
|
4.0%
1/25 • Number of events 1 • Period One: February 1, 2011 through December 31, 2013. Period Two: January 1, 2014 through March 31, 2016.
Data were analyzed for all participants in one arm.
|
|
Gastrointestinal disorders
Dyspepsia
|
4.0%
1/25 • Number of events 1 • Period One: February 1, 2011 through December 31, 2013. Period Two: January 1, 2014 through March 31, 2016.
Data were analyzed for all participants in one arm.
|
|
Psychiatric disorders
Euphoric Mood
|
4.0%
1/25 • Number of events 1 • Period One: February 1, 2011 through December 31, 2013. Period Two: January 1, 2014 through March 31, 2016.
Data were analyzed for all participants in one arm.
|
|
General disorders
Fatigue
|
28.0%
7/25 • Number of events 9 • Period One: February 1, 2011 through December 31, 2013. Period Two: January 1, 2014 through March 31, 2016.
Data were analyzed for all participants in one arm.
|
|
Investigations
Haemoglobin Decreased
|
4.0%
1/25 • Number of events 2 • Period One: February 1, 2011 through December 31, 2013. Period Two: January 1, 2014 through March 31, 2016.
Data were analyzed for all participants in one arm.
|
|
Nervous system disorders
Headache
|
20.0%
5/25 • Number of events 10 • Period One: February 1, 2011 through December 31, 2013. Period Two: January 1, 2014 through March 31, 2016.
Data were analyzed for all participants in one arm.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
4.0%
1/25 • Number of events 1 • Period One: February 1, 2011 through December 31, 2013. Period Two: January 1, 2014 through March 31, 2016.
Data were analyzed for all participants in one arm.
|
|
Psychiatric disorders
Insomnia
|
4.0%
1/25 • Number of events 1 • Period One: February 1, 2011 through December 31, 2013. Period Two: January 1, 2014 through March 31, 2016.
Data were analyzed for all participants in one arm.
|
|
Psychiatric disorders
Irritability
|
4.0%
1/25 • Number of events 1 • Period One: February 1, 2011 through December 31, 2013. Period Two: January 1, 2014 through March 31, 2016.
Data were analyzed for all participants in one arm.
|
|
Nervous system disorders
Memory Impairment
|
4.0%
1/25 • Number of events 1 • Period One: February 1, 2011 through December 31, 2013. Period Two: January 1, 2014 through March 31, 2016.
Data were analyzed for all participants in one arm.
|
|
Nervous system disorders
Mental Impairment
|
4.0%
1/25 • Number of events 1 • Period One: February 1, 2011 through December 31, 2013. Period Two: January 1, 2014 through March 31, 2016.
Data were analyzed for all participants in one arm.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
4.0%
1/25 • Number of events 1 • Period One: February 1, 2011 through December 31, 2013. Period Two: January 1, 2014 through March 31, 2016.
Data were analyzed for all participants in one arm.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.0%
1/25 • Number of events 1 • Period One: February 1, 2011 through December 31, 2013. Period Two: January 1, 2014 through March 31, 2016.
Data were analyzed for all participants in one arm.
|
|
Gastrointestinal disorders
Nausea
|
16.0%
4/25 • Number of events 13 • Period One: February 1, 2011 through December 31, 2013. Period Two: January 1, 2014 through March 31, 2016.
Data were analyzed for all participants in one arm.
|
|
Investigations
Neutrophil Count Decreased
|
8.0%
2/25 • Number of events 4 • Period One: February 1, 2011 through December 31, 2013. Period Two: January 1, 2014 through March 31, 2016.
Data were analyzed for all participants in one arm.
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
4.0%
1/25 • Number of events 1 • Period One: February 1, 2011 through December 31, 2013. Period Two: January 1, 2014 through March 31, 2016.
Data were analyzed for all participants in one arm.
|
|
Vascular disorders
Pallor
|
4.0%
1/25 • Number of events 1 • Period One: February 1, 2011 through December 31, 2013. Period Two: January 1, 2014 through March 31, 2016.
Data were analyzed for all participants in one arm.
|
|
Investigations
Platelet Count Decreased
|
12.0%
3/25 • Number of events 5 • Period One: February 1, 2011 through December 31, 2013. Period Two: January 1, 2014 through March 31, 2016.
Data were analyzed for all participants in one arm.
|
|
Injury, poisoning and procedural complications
Post Procedural Hematoma
|
8.0%
2/25 • Number of events 2 • Period One: February 1, 2011 through December 31, 2013. Period Two: January 1, 2014 through March 31, 2016.
Data were analyzed for all participants in one arm.
|
|
Injury, poisoning and procedural complications
Post Procedural Oedema
|
4.0%
1/25 • Number of events 1 • Period One: February 1, 2011 through December 31, 2013. Period Two: January 1, 2014 through March 31, 2016.
Data were analyzed for all participants in one arm.
|
|
Nervous system disorders
Presyncope
|
4.0%
1/25 • Number of events 1 • Period One: February 1, 2011 through December 31, 2013. Period Two: January 1, 2014 through March 31, 2016.
Data were analyzed for all participants in one arm.
|
|
Injury, poisoning and procedural complications
Procedural Anxiety
|
4.0%
1/25 • Number of events 1 • Period One: February 1, 2011 through December 31, 2013. Period Two: January 1, 2014 through March 31, 2016.
Data were analyzed for all participants in one arm.
|
|
Injury, poisoning and procedural complications
Procedural Complication
|
4.0%
1/25 • Number of events 1 • Period One: February 1, 2011 through December 31, 2013. Period Two: January 1, 2014 through March 31, 2016.
Data were analyzed for all participants in one arm.
|
|
Injury, poisoning and procedural complications
Procedural Dizziness
|
4.0%
1/25 • Number of events 1 • Period One: February 1, 2011 through December 31, 2013. Period Two: January 1, 2014 through March 31, 2016.
Data were analyzed for all participants in one arm.
|
|
Injury, poisoning and procedural complications
Procedural Headache
|
8.0%
2/25 • Number of events 2 • Period One: February 1, 2011 through December 31, 2013. Period Two: January 1, 2014 through March 31, 2016.
Data were analyzed for all participants in one arm.
|
|
Injury, poisoning and procedural complications
Procedural Hypertension
|
68.0%
17/25 • Number of events 44 • Period One: February 1, 2011 through December 31, 2013. Period Two: January 1, 2014 through March 31, 2016.
Data were analyzed for all participants in one arm.
|
|
Injury, poisoning and procedural complications
Procedural Nausea
|
4.0%
1/25 • Number of events 1 • Period One: February 1, 2011 through December 31, 2013. Period Two: January 1, 2014 through March 31, 2016.
Data were analyzed for all participants in one arm.
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
8.0%
2/25 • Number of events 2 • Period One: February 1, 2011 through December 31, 2013. Period Two: January 1, 2014 through March 31, 2016.
Data were analyzed for all participants in one arm.
|
|
Injury, poisoning and procedural complications
Procedural Site Reaction
|
36.0%
9/25 • Number of events 15 • Period One: February 1, 2011 through December 31, 2013. Period Two: January 1, 2014 through March 31, 2016.
Data were analyzed for all participants in one arm.
|
|
General disorders
Thirst
|
4.0%
1/25 • Number of events 1 • Period One: February 1, 2011 through December 31, 2013. Period Two: January 1, 2014 through March 31, 2016.
Data were analyzed for all participants in one arm.
|
|
Ear and labyrinth disorders
Tinnitus
|
4.0%
1/25 • Number of events 1 • Period One: February 1, 2011 through December 31, 2013. Period Two: January 1, 2014 through March 31, 2016.
Data were analyzed for all participants in one arm.
|
|
Injury, poisoning and procedural complications
Vascular Access Site Haematoma
|
16.0%
4/25 • Number of events 4 • Period One: February 1, 2011 through December 31, 2013. Period Two: January 1, 2014 through March 31, 2016.
Data were analyzed for all participants in one arm.
|
|
Injury, poisoning and procedural complications
Vascular Access Site Haemorrhage
|
24.0%
6/25 • Number of events 7 • Period One: February 1, 2011 through December 31, 2013. Period Two: January 1, 2014 through March 31, 2016.
Data were analyzed for all participants in one arm.
|
|
Injury, poisoning and procedural complications
Vascular Access Site Pain
|
32.0%
8/25 • Number of events 8 • Period One: February 1, 2011 through December 31, 2013. Period Two: January 1, 2014 through March 31, 2016.
Data were analyzed for all participants in one arm.
|
|
Injury, poisoning and procedural complications
Vascular Access Site Rupture
|
16.0%
4/25 • Number of events 5 • Period One: February 1, 2011 through December 31, 2013. Period Two: January 1, 2014 through March 31, 2016.
Data were analyzed for all participants in one arm.
|
|
Injury, poisoning and procedural complications
Vascular Access Site Swelling
|
16.0%
4/25 • Number of events 4 • Period One: February 1, 2011 through December 31, 2013. Period Two: January 1, 2014 through March 31, 2016.
Data were analyzed for all participants in one arm.
|
|
General disorders
Vessel Puncture Site Erythema
|
4.0%
1/25 • Number of events 1 • Period One: February 1, 2011 through December 31, 2013. Period Two: January 1, 2014 through March 31, 2016.
Data were analyzed for all participants in one arm.
|
|
General disorders
Vessel Puncture Site Haematoma
|
4.0%
1/25 • Number of events 1 • Period One: February 1, 2011 through December 31, 2013. Period Two: January 1, 2014 through March 31, 2016.
Data were analyzed for all participants in one arm.
|
|
Eye disorders
Visual Impairment
|
4.0%
1/25 • Number of events 1 • Period One: February 1, 2011 through December 31, 2013. Period Two: January 1, 2014 through March 31, 2016.
Data were analyzed for all participants in one arm.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place