Trial Outcomes & Findings for Genetic Predictors of Variability in the Drug-drug Interaction Between Darunavir/Ritonavir and Pravastatin (NCT NCT00630734)
NCT ID: NCT00630734
Last Updated: 2014-05-22
Results Overview
AUC of pravastatin when administered with darunavir/ritonavir divided by AUC of pravastatin when administered alone. The AUC was measured over a 24-hour dosing interval.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
32 participants
Primary outcome timeframe
0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 hours post-dose
Results posted on
2014-05-22
Participant Flow
Healthy volunteers were recruited from the Denver metro area between March 2008 and September 2009.
Participants were genetically screened for solute carrier organic anion transporter family, member 1B1 (SLCO1B1) diplotypes as follows: Group 1, \*1A/\*1A (reference diplotype); Group 2, \*1A/\*1B or \*1B/\*1B diplotypes; and Group 3, subjects with at least one copy of the \*5, \*15, or \*17 haplotype.
Participant milestones
| Measure |
SLCO1B1 Group 1
SLCO1B1 \*1A/\*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
|
SLCO1B1 Group 2
SLCO1B1 \*1A/\*1B or \*1B/\*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18.
|
SLCO1B1 Group 3
Carriers of at least one SLCO1B1 \*5, \*15, or \*17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
|
|---|---|---|---|
|
Overall Study
STARTED
|
11
|
13
|
8
|
|
Overall Study
COMPLETED
|
9
|
12
|
7
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Genetic Predictors of Variability in the Drug-drug Interaction Between Darunavir/Ritonavir and Pravastatin
Baseline characteristics by cohort
| Measure |
SLCO1B1 Group 1
n=9 Participants
SLCO1B1 \*1A/\*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
|
SLCO1B1 Group 2
n=12 Participants
SLCO1B1 \*1A/\*1B or \*1B/\*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
|
SLCO1B1 Group 3
n=7 Participants
Carriers of at least one SLCO1B1 \*5, \*15, or \*17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
36 years
STANDARD_DEVIATION 11 • n=5 Participants
|
37 years
STANDARD_DEVIATION 12 • n=7 Participants
|
39 years
STANDARD_DEVIATION 11 • n=5 Participants
|
36 years
STANDARD_DEVIATION 11 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
12 participants
n=7 Participants
|
7 participants
n=5 Participants
|
28 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 hours post-dosePopulation: The population analyzed included participants who completed the pravastatin alone phase and the pravastatin + darunavir/ritonavir phase of the study.
AUC of pravastatin when administered with darunavir/ritonavir divided by AUC of pravastatin when administered alone. The AUC was measured over a 24-hour dosing interval.
Outcome measures
| Measure |
SLCO1B1 Group 1
n=9 Participants
SLCO1B1\*1A/\*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
|
SLCO1B1 Group 2
n=12 Participants
SLCO1B1 \*1A/\*1B or \*1B/\*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
|
SLCO1B1 Group 3
n=7 Participants
Carriers of at least one SLCO1B1 \*5, \*15, or \*17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
|
|---|---|---|---|
|
Relative Change in Pravastatin Area Under the Plasma Concentration-time Curve (AUC) Over the Dosing Interval
|
1.09 ng*hr/ml
Interval 0.73 to 1.46
|
1.59 ng*hr/ml
Interval 0.83 to 2.36
|
1.75 ng*hr/ml
Interval 0.52 to 2.97
|
PRIMARY outcome
Timeframe: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 hours post-dosePopulation: The population analyzed included participants who completed the pravastatin alone phase and the pravastatin + darunavir/ritonavir phase of the study.
Cmax of pravastatin when administered with darunavir/ritonavir divided by the Cmax of pravastatin when administered alone.
Outcome measures
| Measure |
SLCO1B1 Group 1
n=9 Participants
SLCO1B1\*1A/\*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
|
SLCO1B1 Group 2
n=12 Participants
SLCO1B1 \*1A/\*1B or \*1B/\*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
|
SLCO1B1 Group 3
n=7 Participants
Carriers of at least one SLCO1B1 \*5, \*15, or \*17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
|
|---|---|---|---|
|
Relative Change in Pravastatin Maximum Plasma Concentration (Cmax)
|
1.11 ng/ml
Interval 0.69 to 1.53
|
1.69 ng/ml
Interval 0.83 to 2.55
|
2.32 ng/ml
Interval 0.24 to 4.4
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 hours post-dosePopulation: The population analyzed included participants who completed the pravastatin alone phase and the pravastatin + darunavir/ritonavir phase of the study.
Dosing interval of 24 hours
Outcome measures
| Measure |
SLCO1B1 Group 1
n=9 Participants
SLCO1B1\*1A/\*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
|
SLCO1B1 Group 2
n=12 Participants
SLCO1B1 \*1A/\*1B or \*1B/\*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
|
SLCO1B1 Group 3
n=7 Participants
Carriers of at least one SLCO1B1 \*5, \*15, or \*17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
|
|---|---|---|---|
|
Pravastatin Alone: Pravastatin Area Under the Plasma Concentration-time Curve (AUC) Over the Dosing Interval
|
63 ng*h/ml
Standard Deviation 25.2
|
86.6 ng*h/ml
Standard Deviation 36.3
|
123.4 ng*h/ml
Standard Deviation 80.1
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 hours post-dosePopulation: The population analyzed included participants who completed the pravastatin alone phase and the pravastatin + darunavir/ritonavir phase of the study.
Outcome measures
| Measure |
SLCO1B1 Group 1
n=9 Participants
SLCO1B1\*1A/\*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
|
SLCO1B1 Group 2
n=12 Participants
SLCO1B1 \*1A/\*1B or \*1B/\*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
|
SLCO1B1 Group 3
n=7 Participants
Carriers of at least one SLCO1B1 \*5, \*15, or \*17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
|
|---|---|---|---|
|
Pravastatin Alone: Pravastatin Maximum Plasma Concentration (Cmax)
|
27.7 ng/ml
Standard Deviation 15.4
|
33.3 ng/ml
Standard Deviation 17.1
|
46.2 ng/ml
Standard Deviation 38.6
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 hours post-dosePopulation: The population analyzed included participants who completed the pravastatin alone phase and the pravastatin + darunavir/ritonavir phase of the study.
Dosing interval of 24 hours
Outcome measures
| Measure |
SLCO1B1 Group 1
n=9 Participants
SLCO1B1\*1A/\*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
|
SLCO1B1 Group 2
n=12 Participants
SLCO1B1 \*1A/\*1B or \*1B/\*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
|
SLCO1B1 Group 3
n=7 Participants
Carriers of at least one SLCO1B1 \*5, \*15, or \*17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
|
|---|---|---|---|
|
Pravastatin + Darunavir/Ritonavir: Pravastatin Area Under the Plasma Concentration-time Curve (AUC) Over the Dosing Interval
|
68.4 ng*h/ml
Standard Deviation 37.3
|
106.8 ng*h/ml
Standard Deviation 47.9
|
145.7 ng*h/ml
Standard Deviation 36.9
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 hours post-dosePopulation: The population analyzed included participants who completed the pravastatin alone phase and the pravastatin + darunavir/ritonavir phase of the study.
Outcome measures
| Measure |
SLCO1B1 Group 1
n=9 Participants
SLCO1B1\*1A/\*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
|
SLCO1B1 Group 2
n=12 Participants
SLCO1B1 \*1A/\*1B or \*1B/\*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
|
SLCO1B1 Group 3
n=7 Participants
Carriers of at least one SLCO1B1 \*5, \*15, or \*17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
|
|---|---|---|---|
|
Pravastatin + Darunavir/Ritonavir: Pravastatin Maximum Plasma Concentration (Cmax)
|
30.1 ng/ml
Standard Deviation 19.7
|
42.4 ng/ml
Standard Deviation 23.0
|
52.8 ng/ml
Standard Deviation 11.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0, 1, 2, 3, 4, 5, 6, 8, 12 hours post-dosePopulation: The population analyzed included participants who completed the pravastatin alone phase and the pravastatin + darunavir/ritonavir phase of the study.
AUC of darunavir over a 12-hour dosing interval.
Outcome measures
| Measure |
SLCO1B1 Group 1
n=9 Participants
SLCO1B1\*1A/\*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
|
SLCO1B1 Group 2
n=12 Participants
SLCO1B1 \*1A/\*1B or \*1B/\*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
|
SLCO1B1 Group 3
n=7 Participants
Carriers of at least one SLCO1B1 \*5, \*15, or \*17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
|
|---|---|---|---|
|
Darunavir Area Under the Plasma Concentration-time Curve (AUC) Over the Dosing Interval
|
58552 ng*h/ml
Standard Deviation 29442
|
63679 ng*h/ml
Standard Deviation 16985
|
60156 ng*h/ml
Standard Deviation 13909
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0, 1, 2, 3, 4, 5, 6, 8, 12 hours post-dosePopulation: The population analyzed included participants who completed the pravastatin alone phase and the pravastatin + darunavir/ritonavir phase of the study.
Cmax of darunavir over a 12-hour dosing interval
Outcome measures
| Measure |
SLCO1B1 Group 1
n=9 Participants
SLCO1B1\*1A/\*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
|
SLCO1B1 Group 2
n=12 Participants
SLCO1B1 \*1A/\*1B or \*1B/\*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
|
SLCO1B1 Group 3
n=7 Participants
Carriers of at least one SLCO1B1 \*5, \*15, or \*17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
|
|---|---|---|---|
|
Darunavir Maximum Plasma Concentration (Cmax)
|
7770 ng/ml
Standard Deviation 3483
|
8047 ng/ml
Standard Deviation 2023
|
7789 ng/ml
Standard Deviation 1467
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0, 1, 2, 3, 4, 5, 6, 8, 12 hours post-dosePopulation: The population analyzed included participants who completed the pravastatin alone phase and the pravastatin + darunavir/ritonavir phase of the study.
AUC of ritonavir over a 12-hour dosing interval.
Outcome measures
| Measure |
SLCO1B1 Group 1
n=9 Participants
SLCO1B1\*1A/\*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
|
SLCO1B1 Group 2
n=12 Participants
SLCO1B1 \*1A/\*1B or \*1B/\*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
|
SLCO1B1 Group 3
n=7 Participants
Carriers of at least one SLCO1B1 \*5, \*15, or \*17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
|
|---|---|---|---|
|
Ritonavir Area Under the Plasma Concentration-time Curve (AUC) Over the Dosing Interval
|
5239 ng*hr/ml
Standard Deviation 3835
|
7178 ng*hr/ml
Standard Deviation 3520
|
7907 ng*hr/ml
Standard Deviation 3618
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0,1, 2, 3, 4, 5, 6, 8, 12 hours post-dosePopulation: The population analyzed included participants who completed the pravastatin alone phase and the pravastatin + darunavir/ritonavir phase of the study.
Cmax of ritonavir over a 12-hour dosing interval
Outcome measures
| Measure |
SLCO1B1 Group 1
n=9 Participants
SLCO1B1\*1A/\*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
|
SLCO1B1 Group 2
n=12 Participants
SLCO1B1 \*1A/\*1B or \*1B/\*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
|
SLCO1B1 Group 3
n=7 Participants
Carriers of at least one SLCO1B1 \*5, \*15, or \*17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
|
|---|---|---|---|
|
Ritonavir Maximum Plasma Concentration (Cmax)
|
844 ng/ml
Standard Deviation 708
|
1143 ng/ml
Standard Deviation 649
|
1279 ng/ml
Standard Deviation 748
|
Adverse Events
Pravastatin Alone
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Darunavir/Ritonavir Alone
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Pravastatin + Darunavir/Ritonavir
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pravastatin Alone
n=32 participants at risk
Pravastatin 40 mg by mouth daily on days 1-4; Includes 32 participants who received at least one dose of pravastatin 40 mg during days 1-4.
|
Darunavir/Ritonavir Alone
n=31 participants at risk
Darunavir/Ritonavir 600/100 mg by mouth twice daily on days 12-14; Includes 31 participants who received at least one dose of darunavir/ritonavir during days 12-14.
|
Pravastatin + Darunavir/Ritonavir
n=28 participants at risk
Darunavir/ritonavir 600/100 mg by mouth twice daily and pravastatin 40 mg by mouth once daily on days 15-18. Includes 28 participants who received at least one dose of darunavir/ritonavir and pravastatin during days 15-18.
|
|---|---|---|---|
|
General disorders
Angioedema
|
0.00%
0/32
|
0.00%
0/31
|
3.6%
1/28 • Number of events 1
|
Other adverse events
| Measure |
Pravastatin Alone
n=32 participants at risk
Pravastatin 40 mg by mouth daily on days 1-4; Includes 32 participants who received at least one dose of pravastatin 40 mg during days 1-4.
|
Darunavir/Ritonavir Alone
n=31 participants at risk
Darunavir/Ritonavir 600/100 mg by mouth twice daily on days 12-14; Includes 31 participants who received at least one dose of darunavir/ritonavir during days 12-14.
|
Pravastatin + Darunavir/Ritonavir
n=28 participants at risk
Darunavir/ritonavir 600/100 mg by mouth twice daily and pravastatin 40 mg by mouth once daily on days 15-18. Includes 28 participants who received at least one dose of darunavir/ritonavir and pravastatin during days 15-18.
|
|---|---|---|---|
|
General disorders
Headache
|
25.0%
8/32 • Number of events 8
|
25.8%
8/31 • Number of events 8
|
21.4%
6/28 • Number of events 6
|
|
General disorders
Fatigue
|
6.2%
2/32 • Number of events 2
|
16.1%
5/31 • Number of events 5
|
3.6%
1/28 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
6.2%
2/32 • Number of events 2
|
6.5%
2/31 • Number of events 2
|
0.00%
0/28
|
|
Musculoskeletal and connective tissue disorders
Muscle pain
|
9.4%
3/32 • Number of events 3
|
9.7%
3/31 • Number of events 3
|
10.7%
3/28 • Number of events 3
|
|
General disorders
Dizziness
|
6.2%
2/32 • Number of events 2
|
0.00%
0/31
|
3.6%
1/28 • Number of events 1
|
|
General disorders
Hypoalbuminemia
|
10.7%
3/28 • Number of events 3
|
9.7%
3/31 • Number of events 3
|
7.1%
2/28 • Number of events 2
|
|
Gastrointestinal disorders
Nausea/Vomiting/Dyspepsia/Abdominal Pain
|
0.00%
0/32
|
38.7%
12/31 • Number of events 12
|
10.7%
3/28 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhea
|
3.1%
1/32 • Number of events 1
|
25.8%
8/31 • Number of events 8
|
46.4%
13/28 • Number of events 13
|
|
Gastrointestinal disorders
Anorexia
|
0.00%
0/32
|
6.5%
2/31 • Number of events 2
|
3.6%
1/28 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Shoulder/Neck Pain
|
3.1%
1/32 • Number of events 1
|
9.7%
3/31 • Number of events 3
|
3.6%
1/28 • Number of events 1
|
Additional Information
Christina Aquilante, Pharm.D.
University of Colorado Denver
Phone: 303-724-6126
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Prior to publication or presentation, the PI will provide the sponsor with at least 60 days for review of a manuscript
- Publication restrictions are in place
Restriction type: OTHER