Trial Outcomes & Findings for Study of ABT-267 in Treatment Naive Hepatitis C Virus (HCV) Genotype 1 Infected Subjects (NCT NCT01314261)
NCT ID: NCT01314261
Last Updated: 2018-07-02
Results Overview
Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Rapid virologic response was defined as HCV RNA levels \< the lower limit of detection (\< 15 IU/mL) at Week 4. Data are reported as percentage of participants with RVR.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
37 participants
Primary outcome timeframe
Week 4
Results posted on
2018-07-02
Participant Flow
Participant milestones
| Measure |
ABT-267 (5 mg) Once Daily + pegIFN/RBV
Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
|
ABT-267 (50 mg) Once Daily + pegIFN/RBV
Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
|
ABT-267 (200 mg) Once Daily + pegIFN/RBV
Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
|
Placebo + pegIFN/RBV
Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
10
|
9
|
|
Overall Study
Discontinued ABT-267 or Placebo
|
1
|
0
|
1
|
0
|
|
Overall Study
Discontinued pegIFN/RBV
|
1
|
4
|
5
|
1
|
|
Overall Study
COMPLETED
|
7
|
5
|
7
|
6
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
3
|
3
|
Reasons for withdrawal
| Measure |
ABT-267 (5 mg) Once Daily + pegIFN/RBV
Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
|
ABT-267 (50 mg) Once Daily + pegIFN/RBV
Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
|
ABT-267 (200 mg) Once Daily + pegIFN/RBV
Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
|
Placebo + pegIFN/RBV
Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
2
|
2
|
|
Overall Study
Virologic Failure
|
0
|
1
|
0
|
1
|
Baseline Characteristics
Study of ABT-267 in Treatment Naive Hepatitis C Virus (HCV) Genotype 1 Infected Subjects
Baseline characteristics by cohort
| Measure |
ABT-267 (5 mg) Once Daily + pegIFN/RBV
n=9 Participants
Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
|
ABT-267 (50 mg) Once Daily + pegIFN/RBV
n=9 Participants
Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
|
ABT-267 (200 mg) Once Daily + pegIFN/RBV
n=10 Participants
Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
|
Placebo + pegIFN/RBV
n=9 Participants
Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
50.1 years
STANDARD_DEVIATION 11.32 • n=39 Participants
|
49.2 years
STANDARD_DEVIATION 9.55 • n=41 Participants
|
46.0 years
STANDARD_DEVIATION 10.26 • n=35 Participants
|
48.1 years
STANDARD_DEVIATION 12.32 • n=31 Participants
|
48.3 years
STANDARD_DEVIATION 10.55 • n=146 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
4 Participants
n=31 Participants
|
15 Participants
n=146 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
5 Participants
n=31 Participants
|
22 Participants
n=146 Participants
|
PRIMARY outcome
Timeframe: Week 4Population: All 37 participants enrolled in the study received at least 1 dose of study drug and were included in the intent-to-treat population for efficacy and safety analyses.
Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Rapid virologic response was defined as HCV RNA levels \< the lower limit of detection (\< 15 IU/mL) at Week 4. Data are reported as percentage of participants with RVR.
Outcome measures
| Measure |
ABT-267 (5 mg) Once Daily + pegIFN/RBV
n=9 Participants
Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
|
ABT-267 (50 mg) Once Daily + pegIFN/RBV
n=9 Participants
Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
|
ABT-267 (200 mg) Once Daily + pegIFN/RBV
n=10 Participants
Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
|
Placebo + pegIFN/RBV
n=9 Participants
Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
|
|---|---|---|---|---|
|
Percentage of Participants With 4-week Rapid Virologic Response (RVR)
|
33.3 percentage of participants
|
55.6 percentage of participants
|
70.0 percentage of participants
|
22.2 percentage of participants
|
PRIMARY outcome
Timeframe: Immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)Population: Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters.
Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-267 using validated analytical methods. The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the plasma after administration in a dosing interval. The Cmax of ABT-267 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.
Outcome measures
| Measure |
ABT-267 (5 mg) Once Daily + pegIFN/RBV
n=9 Participants
Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
|
ABT-267 (50 mg) Once Daily + pegIFN/RBV
n=9 Participants
Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
|
ABT-267 (200 mg) Once Daily + pegIFN/RBV
n=9 Participants
Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
|
Placebo + pegIFN/RBV
Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
|
|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of ABT-267
|
10.7 ng/mL
Standard Deviation 3.73
|
148 ng/mL
Standard Deviation 80.8
|
535 ng/mL
Standard Deviation 160
|
—
|
PRIMARY outcome
Timeframe: Immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)Population: Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters.
Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-267 using validated analytical methods. The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax. The Tmax of ABT-267 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.
Outcome measures
| Measure |
ABT-267 (5 mg) Once Daily + pegIFN/RBV
n=9 Participants
Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
|
ABT-267 (50 mg) Once Daily + pegIFN/RBV
n=9 Participants
Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
|
ABT-267 (200 mg) Once Daily + pegIFN/RBV
n=9 Participants
Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
|
Placebo + pegIFN/RBV
Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
|
|---|---|---|---|---|
|
Time to Maximum Plasma Concentration (Tmax) of ABT-267
|
3.3 Hours
Standard Deviation 1.0
|
3.8 Hours
Standard Deviation 1.6
|
4.2 Hours
Standard Deviation 1.6
|
—
|
PRIMARY outcome
Timeframe: Immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; prior to dose on Day 2 (24 hours after Day 1 dose); and at each subsequent study visit up to Week 12Population: Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters.
Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; prior to dose on Day 2 (24 hours after Day 1 dose); and at each subsequent study visit. The samples were analyzed for the concentration of ABT-267 using validated analytical methods. The area under the plasma concentration -time curve (AUC; measured in ng\*hr/mL) is a method of measurement of the total exposure of a drug in blood plasma. The AUC24 of ABT-267 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.
Outcome measures
| Measure |
ABT-267 (5 mg) Once Daily + pegIFN/RBV
n=7 Participants
Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
|
ABT-267 (50 mg) Once Daily + pegIFN/RBV
n=3 Participants
Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
|
ABT-267 (200 mg) Once Daily + pegIFN/RBV
n=4 Participants
Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
|
Placebo + pegIFN/RBV
Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
|
|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24) Post-dose of ABT-267
|
115 ng*hr/mL
Standard Deviation 35.5
|
2200 ng*hr/mL
Standard Deviation 1090
|
6130 ng*hr/mL
Standard Deviation 675
|
—
|
PRIMARY outcome
Timeframe: At each study visit from Week 1 to Week 12Population: Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters. When a different number of participants at a specific time point was used to analyze the data in the outcome measure, the n (number of participants) for each arm is denoted in the Category Title.
Blood samples were collected at each study visit from Week 1 to Week 12. The samples were analyzed for the concentration of RBV (measured in ng/mL) using validated analytical methods and RBV concentrations in plasma were summarized at each visit. Data are reported as the median (range).
Outcome measures
| Measure |
ABT-267 (5 mg) Once Daily + pegIFN/RBV
n=9 Participants
Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
|
ABT-267 (50 mg) Once Daily + pegIFN/RBV
n=9 Participants
Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
|
ABT-267 (200 mg) Once Daily + pegIFN/RBV
n=10 Participants
Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
|
Placebo + pegIFN/RBV
n=9 Participants
Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
|
|---|---|---|---|---|
|
Plasma Concentrations of Ribavirin (RBV)
Week 1
|
1330 ng/mL
Interval 852.0 to 3950.0
|
1470 ng/mL
Interval 847.0 to 2700.0
|
1060 ng/mL
Interval 742.0 to 1700.0
|
1190 ng/mL
Interval 860.0 to 2130.0
|
|
Plasma Concentrations of Ribavirin (RBV)
Week 2
|
1890 ng/mL
Interval 484.0 to 6160.0
|
1640 ng/mL
Interval 328.0 to 3810.0
|
1420 ng/mL
Interval 1140.0 to 2150.0
|
1360 ng/mL
Interval 1130.0 to 2740.0
|
|
Plasma Concentrations of Ribavirin (RBV)
Week 4 (n=8, 8, 10, 9)
|
1900 ng/mL
Interval 1110.0 to 4500.0
|
1680 ng/mL
Interval 279.0 to 3290.0
|
1580 ng/mL
Interval 1250.0 to 2110.0
|
1950 ng/mL
Interval 842.0 to 3520.0
|
|
Plasma Concentrations of Ribavirin (RBV)
Week 6 (n=8, 9, 9, 9)
|
2000 ng/mL
Interval 1390.0 to 3250.0
|
1510 ng/mL
Interval 0.0 to 3210.0
|
1780 ng/mL
Interval 890.0 to 2280.0
|
1900 ng/mL
Interval 1380.0 to 4300.0
|
|
Plasma Concentrations of Ribavirin (RBV)
Week 8 (n=8, 9, 9, 9)
|
2080 ng/mL
Interval 712.0 to 3400.0
|
1710 ng/mL
Interval 277.0 to 3160.0
|
1650 ng/mL
Interval 1120.0 to 2290.0
|
2280 ng/mL
Interval 277.0 to 4630.0
|
|
Plasma Concentrations of Ribavirin (RBV)
Week 12 (n=8, 9, 9, 9)
|
2510 ng/mL
Interval 1300.0 to 4320.0
|
1740 ng/mL
Interval 0.0 to 2240.0
|
1800 ng/mL
Interval 1270.0 to 2590.0
|
1940 ng/mL
Interval 0.0 to 4760.0
|
PRIMARY outcome
Timeframe: At each study visit from Week 1 to Week 12Population: Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters. When a different number of participants at a specific time point was used to analyze the data in the outcome measure, the n (number of participants) for each arm is denoted in the Category Title.
Blood samples were collected at each study visit from Week 1 to Week 12. The samples were analyzed for the concentration of pegIFN (measured in ng/mL) using validated analytical methods and pegIFN concentrations in serum were summarized at each visit. Data are reported as the median (range).
Outcome measures
| Measure |
ABT-267 (5 mg) Once Daily + pegIFN/RBV
n=9 Participants
Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
|
ABT-267 (50 mg) Once Daily + pegIFN/RBV
n=9 Participants
Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
|
ABT-267 (200 mg) Once Daily + pegIFN/RBV
n=10 Participants
Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
|
Placebo + pegIFN/RBV
n=9 Participants
Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
|
|---|---|---|---|---|
|
Serum Concentrations of Pegylated Interferon (pegIFN)
Week 1
|
7.50 ng/mL
Interval 2.08 to 13.4
|
6.12 ng/mL
Interval 2.26 to 9.83
|
4.30 ng/mL
Interval 0.0 to 13.9
|
4.83 ng/mL
Interval 2.09 to 20.0
|
|
Serum Concentrations of Pegylated Interferon (pegIFN)
Week 2
|
8.75 ng/mL
Interval 4.0 to 24.4
|
9.22 ng/mL
Interval 4.64 to 14.4
|
7.52 ng/mL
Interval 0.0 to 20.1
|
6.87 ng/mL
Interval 1.04 to 16.4
|
|
Serum Concentrations of Pegylated Interferon (pegIFN)
Week 4 (n=9, 9, 10, 9)
|
11.8 ng/mL
Interval 2.97 to 26.2
|
7.72 ng/mL
Interval 3.07 to 16.1
|
8.23 ng/mL
Interval 0.0 to 23.4
|
8.76 ng/mL
Interval 5.12 to 16.9
|
|
Serum Concentrations of Pegylated Interferon (pegIFN)
Week 6 (n=8, 9, 9, 9)
|
10.9 ng/mL
Interval 6.09 to 21.0
|
9.35 ng/mL
Interval 5.2 to 15.9
|
14.6 ng/mL
Interval 3.59 to 24.1
|
10.9 ng/mL
Interval 6.21 to 17.3
|
|
Serum Concentrations of Pegylated Interferon (pegIFN)
Week 8 (n=8, 9, 9, 9)
|
9.91 ng/mL
Interval 5.4 to 22.7
|
10.1 ng/mL
Interval 2.47 to 15.7
|
12.1 ng/mL
Interval 3.94 to 30.3
|
11.0 ng/mL
Interval 4.74 to 17.8
|
|
Serum Concentrations of Pegylated Interferon (pegIFN)
Week 12 (n=8, 9, 9, 9)
|
14.4 ng/mL
Interval 4.83 to 24.2
|
6.16 ng/mL
Interval 0.0 to 15.3
|
15.2 ng/mL
Interval 6.39 to 25.6
|
8.91 ng/mL
Interval 0.0 to 19.3
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: All 37 participants enrolled in the study received at least 1 dose of study drug and were included in the intent-to-treat population for efficacy analyses.
Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Partial EVR was defined as HCV RNA levels that decreased \> 2 log10 IU/mL at Week 12 as compared to baseline HCV RNA levels. Data are reported as the percentage of participants with pEVR.
Outcome measures
| Measure |
ABT-267 (5 mg) Once Daily + pegIFN/RBV
n=9 Participants
Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
|
ABT-267 (50 mg) Once Daily + pegIFN/RBV
n=9 Participants
Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
|
ABT-267 (200 mg) Once Daily + pegIFN/RBV
n=10 Participants
Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
|
Placebo + pegIFN/RBV
n=9 Participants
Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
|
|---|---|---|---|---|
|
Percentage of Participants With Partial Early Virologic Response (pEVR)
|
100.0 percentage of participants
|
88.9 percentage of participants
|
90.0 percentage of participants
|
77.8 percentage of participants
|
SECONDARY outcome
Timeframe: Week 12Population: All 37 participants enrolled in the study received at least 1 dose of study drug and were included in the intent-to-treat population for efficacy analysis.
Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Complete EVR was defined as HCV RNA \< the lower limit of quantification (\< 25 IU/mL) at Week 12. Data are reported as the percentage of participants with cEVR.
Outcome measures
| Measure |
ABT-267 (5 mg) Once Daily + pegIFN/RBV
n=9 Participants
Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
|
ABT-267 (50 mg) Once Daily + pegIFN/RBV
n=9 Participants
Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
|
ABT-267 (200 mg) Once Daily + pegIFN/RBV
n=10 Participants
Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
|
Placebo + pegIFN/RBV
n=9 Participants
Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
|
|---|---|---|---|---|
|
Percentage of Participants With Complete Early Virologic Response (cEVR)
|
100.0 percentage of participants
|
88.9 percentage of participants
|
80.0 percentage of participants
|
66.7 percentage of participants
|
SECONDARY outcome
Timeframe: 12 weeks after the last dose of pegIFN/RBVPopulation: All 37 participants enrolled in the study received at least 1 dose of study drug and were included in the intent-to-treat population for efficacy analyses.
Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Sustained virologic response was defined as HCV RNA levels \< the lower limit of quantification (\< 25 IU/mL) 12 weeks after the last dose of pegIFN/RBV. Data are reported as the percentage of participants with SVR12.
Outcome measures
| Measure |
ABT-267 (5 mg) Once Daily + pegIFN/RBV
n=9 Participants
Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
|
ABT-267 (50 mg) Once Daily + pegIFN/RBV
n=9 Participants
Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
|
ABT-267 (200 mg) Once Daily + pegIFN/RBV
n=10 Participants
Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
|
Placebo + pegIFN/RBV
n=9 Participants
Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
|
|---|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-pegylated Interferon/Ribavirin (pegIFN/RBV) Dosing
|
66.7 percentage of participants
|
66.7 percentage of participants
|
60.0 percentage of participants
|
33.3 percentage of participants
|
SECONDARY outcome
Timeframe: 24 weeks after the last dose of pegIFN/RBVPopulation: All 37 participants enrolled in the study received at least 1 dose of study drug and were included in the intent-to-treat population for efficacy analyses.
Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Sustained virologic response was defined as HCV RNA levels \< the lower limit of quantification (\< 25 IU/mL) 24 weeks after the last dose of pegIFN/RBV. Data are reported as the percentage of participants with SVR24.
Outcome measures
| Measure |
ABT-267 (5 mg) Once Daily + pegIFN/RBV
n=9 Participants
Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
|
ABT-267 (50 mg) Once Daily + pegIFN/RBV
n=9 Participants
Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
|
ABT-267 (200 mg) Once Daily + pegIFN/RBV
n=10 Participants
Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
|
Placebo + pegIFN/RBV
n=9 Participants
Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
|
|---|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-pegylated Interferon/Ribavirin (pegIFN/RBV) Dosing
|
55.6 percentage of participants
|
44.4 percentage of participants
|
50.0 percentage of participants
|
22.2 percentage of participants
|
SECONDARY outcome
Timeframe: Approximately 12 weeksPopulation: All 37 participants enrolled in the study received at least 1 dose of study drug and were included in the intent-to-treat population for efficacy analyses.
Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Time to suppression was defined as the time (measured in days) to HCV RNA levels \< the lower limit of quantification (\< 25 IU/mL). Data are reported as the median number of days.
Outcome measures
| Measure |
ABT-267 (5 mg) Once Daily + pegIFN/RBV
n=9 Participants
Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
|
ABT-267 (50 mg) Once Daily + pegIFN/RBV
n=9 Participants
Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
|
ABT-267 (200 mg) Once Daily + pegIFN/RBV
n=10 Participants
Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
|
Placebo + pegIFN/RBV
n=9 Participants
Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
|
|---|---|---|---|---|
|
Median Time to Suppression of Hepatitis C Virus Ribonucleic Acid (HCV RNA)
|
27.0 Days
Interval 7.0 to 43.0
|
16.0 Days
Interval 7.0 to 42.0
|
21.5 Days
Interval 7.0 to 29.0
|
84.0 Days
The confidence limit for the placebo group is not calculated as the participants were either suppressed at Week 12 (end of the time frame), or never suppressed and censored at Week 12.
|
SECONDARY outcome
Timeframe: Week 4 through Week 12Population: All 37 participants enrolled in the study received at least 1 dose of study drug and were included in the intent-to-treat population for efficacy analyses.
Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Extended RVR was defined as HCV RNA levels \< the lower level of quantification (\< 25 IU/mL) at Weeks 4 through 12. Data are reported as the percentage of participants with eRVR.
Outcome measures
| Measure |
ABT-267 (5 mg) Once Daily + pegIFN/RBV
n=9 Participants
Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
|
ABT-267 (50 mg) Once Daily + pegIFN/RBV
n=9 Participants
Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
|
ABT-267 (200 mg) Once Daily + pegIFN/RBV
n=10 Participants
Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
|
Placebo + pegIFN/RBV
n=9 Participants
Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
|
|---|---|---|---|---|
|
Percentage of Participants With Extended Rapid Virologic Response (eRVR)
|
77.8 percentage of participants
|
77.8 percentage of participants
|
80.0 percentage of participants
|
22.2 percentage of participants
|
Adverse Events
ABT-267 (5 mg) Once Daily + pegIFN/RBV
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
ABT-267 (50 mg) Once Daily + pegIFN/RBV
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
ABT-267 (200 mg) Once Daily + pegIFN/RBV
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo + pegIFN/RBV
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ABT-267 (5 mg) Once Daily + pegIFN/RBV
n=9 participants at risk
Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
|
ABT-267 (50 mg) Once Daily + pegIFN/RBV
n=9 participants at risk
Participants were given 10 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
|
ABT-267 (200 mg) Once Daily + pegIFN/RBV
n=10 participants at risk
Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
|
Placebo + pegIFN/RBV
n=9 participants at risk
Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
|
|---|---|---|---|---|
|
Cardiac disorders
PALPITATIONS
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Ear and labyrinth disorders
EAR DISCOMFORT
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Blood and lymphatic system disorders
ANAEMIA
|
22.2%
2/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
22.2%
2/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
20.0%
2/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
10.0%
1/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
22.2%
2/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
20.0%
2/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
10.0%
1/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Ear and labyrinth disorders
VERTIGO
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
10.0%
1/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Eye disorders
BLEPHARITIS
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
10.0%
1/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Eye disorders
EYE INFLAMMATION
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Eye disorders
VISION BLURRED
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Eye disorders
VISUAL IMPAIRMENT
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
10.0%
1/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
10.0%
1/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
10.0%
1/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN LOWER
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
10.0%
1/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Gastrointestinal disorders
ABDOMINAL TENDERNESS
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
10.0%
1/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Gastrointestinal disorders
DIARRHOEA
|
22.2%
2/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
10.0%
1/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Gastrointestinal disorders
DRY MOUTH
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
10.0%
1/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Gastrointestinal disorders
FLATULENCE
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
10.0%
1/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Gastrointestinal disorders
GLOSSITIS
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
General disorders
GAIT DISTURBANCE
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Gastrointestinal disorders
NAUSEA
|
22.2%
2/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
33.3%
3/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
40.0%
4/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
33.3%
3/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Gastrointestinal disorders
STOMATITIS
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Gastrointestinal disorders
TONGUE DISORDER
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
10.0%
1/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Gastrointestinal disorders
TOOTHACHE
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
10.0%
1/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Gastrointestinal disorders
VOMITING
|
22.2%
2/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
22.2%
2/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
30.0%
3/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
22.2%
2/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
General disorders
CHILLS
|
33.3%
3/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
22.2%
2/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
10.0%
1/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
General disorders
FATIGUE
|
77.8%
7/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
66.7%
6/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
50.0%
5/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
66.7%
6/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
General disorders
FEELING ABNORMAL
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
22.2%
2/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
General disorders
INJECTION SITE ERYTHEMA
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
20.0%
2/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
General disorders
IRRITABILITY
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
General disorders
NODULE
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
10.0%
1/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
General disorders
PAIN
|
33.3%
3/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
30.0%
3/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
General disorders
PYREXIA
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
10.0%
1/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Infections and infestations
ABSCESS LIMB
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
10.0%
1/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Infections and infestations
BRONCHITIS
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Infections and infestations
ORAL FUNGAL INFECTION
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Infections and infestations
SINUSITIS
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Infections and infestations
STAPHYLOCOCCAL INFECTION
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
10.0%
1/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Infections and infestations
TOOTH ABSCESS
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
10.0%
1/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Injury, poisoning and procedural complications
ARTHROPOD BITE
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
10.0%
1/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Injury, poisoning and procedural complications
LACERATION
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
10.0%
1/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Injury, poisoning and procedural complications
LIGAMENT SPRAIN
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Injury, poisoning and procedural complications
ROAD TRAFFIC ACCIDENT
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Injury, poisoning and procedural complications
TOXICITY TO VARIOUS AGENTS
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Investigations
BLOOD GLUCOSE INCREASED
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
10.0%
1/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Investigations
WEIGHT DECREASED
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
10.0%
1/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
22.2%
2/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
22.2%
2/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
10.0%
1/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
10.0%
1/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Metabolism and nutrition disorders
VITAMIN D DEFICIENCY
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
10.0%
1/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
10.0%
1/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
10.0%
1/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Nervous system disorders
DISTURBANCE IN ATTENTION
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Nervous system disorders
DIZZINESS
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Nervous system disorders
HEADACHE
|
33.3%
3/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
33.3%
3/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
30.0%
3/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
22.2%
2/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Nervous system disorders
HYPERAESTHESIA
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Nervous system disorders
MEMORY IMPAIRMENT
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Nervous system disorders
MIGRAINE
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
10.0%
1/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Nervous system disorders
PSYCHOMOTOR HYPERACTIVITY
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
10.0%
1/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Nervous system disorders
TREMOR
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Psychiatric disorders
ANXIETY
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
22.2%
2/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
20.0%
2/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
22.2%
2/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
10.0%
1/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Psychiatric disorders
DEPRESSION
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
20.0%
2/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Psychiatric disorders
INSOMNIA
|
22.2%
2/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
10.0%
1/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
22.2%
2/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Psychiatric disorders
MOOD ALTERED
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
10.0%
1/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Psychiatric disorders
MOOD SWINGS
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
10.0%
1/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Psychiatric disorders
NIGHTMARE
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
10.0%
1/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Psychiatric disorders
RESTLESSNESS
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
10.0%
1/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Reproductive system and breast disorders
ERECTILE DYSFUNCTION
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Reproductive system and breast disorders
POSTMENOPAUSAL HAEMORRHAGE
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
22.2%
2/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
10.0%
1/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
33.3%
3/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
10.0%
1/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Skin and subcutaneous tissue disorders
HEAT RASH
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
10.0%
1/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
22.2%
2/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
10.0%
1/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Skin and subcutaneous tissue disorders
PRURITUS GENERALISED
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Skin and subcutaneous tissue disorders
RASH
|
33.3%
3/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
30.0%
3/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
22.2%
2/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Skin and subcutaneous tissue disorders
RASH ERYTHEMATOUS
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Skin and subcutaneous tissue disorders
RASH GENERALISED
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
|
Vascular disorders
HOT FLUSH
|
11.1%
1/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/10 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
0.00%
0/9 • Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
|
Additional Information
Global Medical Services
AbbVie (prior sponsor, Abbott)
Phone: 800-633-9110
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER