Trial Outcomes & Findings for A Study of Efficacy of New Doses of Xolair to Protect From Allergen Challenge in Groups of Asthma Patients Defined by IgE Levels (NCT NCT00624832)
NCT ID: NCT00624832
Last Updated: 2011-04-19
Results Overview
The EAR was defined as the maximum percent drop in forced expiratory volume in one second (FEV1) in the first 30 minutes after the challenge: EAR = 100\* \[ FEV1 (0) - Minimum FEV1 (10, 15, 30 min)\] / FEV1 (0). For FEV1 (0), the "best post saline (Control) FEV1" was used. The EAR was analyzed using a linear (ANCOVA) model with a fixed effect for treatment groups and the EAR from the baseline challenge was used as a covariate.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
60 participants
Primary outcome timeframe
Week 8, Week 16
Results posted on
2011-04-19
Participant Flow
Participant milestones
| Measure |
Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL)
Patients with screening Immunoglobulin E (IgE) levels = 30-300 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
|
Xolair (Immunoglobulin E (IgE) = 700- 2000 IU/mL)
Patients with screening Immunoglobulin E (IgE) levels = 700- 2000 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight.
|
Xolair (Immunoglobulin E (IgE) = 301- 699 IU/mL)
Patients with screening Immunoglobulin E (IgE) levels = 301- 699 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight.
|
Placebo Comparator
By subcutaneous injection of a solution with a concentration of 125 mg/mL placebo in a supine position: Patients in Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL) group received doses of 150 mg to 375 mg of placebo every 2 or 4 weeks for 12 or 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 700- 2000 IU/mL) group received doses of 450 mg, 525 mg, or 600 mg of placebo every 2 weeks for 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 301- 699 IU/mL) group received doses of 225 mg to 375 mg of placebo every 2 weeks for 6 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
18
|
16
|
10
|
16
|
|
Overall Study
COMPLETED
|
16
|
15
|
10
|
15
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL)
Patients with screening Immunoglobulin E (IgE) levels = 30-300 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
|
Xolair (Immunoglobulin E (IgE) = 700- 2000 IU/mL)
Patients with screening Immunoglobulin E (IgE) levels = 700- 2000 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight.
|
Xolair (Immunoglobulin E (IgE) = 301- 699 IU/mL)
Patients with screening Immunoglobulin E (IgE) levels = 301- 699 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight.
|
Placebo Comparator
By subcutaneous injection of a solution with a concentration of 125 mg/mL placebo in a supine position: Patients in Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL) group received doses of 150 mg to 375 mg of placebo every 2 or 4 weeks for 12 or 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 700- 2000 IU/mL) group received doses of 450 mg, 525 mg, or 600 mg of placebo every 2 weeks for 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 301- 699 IU/mL) group received doses of 225 mg to 375 mg of placebo every 2 weeks for 6 weeks.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
1
|
|
Overall Study
Abnormal Laboratory Value
|
2
|
0
|
0
|
0
|
Baseline Characteristics
A Study of Efficacy of New Doses of Xolair to Protect From Allergen Challenge in Groups of Asthma Patients Defined by IgE Levels
Baseline characteristics by cohort
| Measure |
Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL)
n=18 Participants
Patients with screening Immunoglobulin E (IgE) levels = 30-300 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
|
Xolair (Immunoglobulin E (IgE) = 700- 2000 IU/mL)
n=16 Participants
Patients with screening Immunoglobulin E (IgE) levels = 700- 2000 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight.
|
Xolair (Immunoglobulin E (IgE) = 301- 699 IU/mL)
n=10 Participants
Patients with screening Immunoglobulin E (IgE) levels = 301- 699 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight.
|
Placebo Comparator
n=16 Participants
By subcutaneous injection of a solution with a concentration of 125 mg/mL placebo in a supine position: Patients in Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL) group received doses of 150 mg to 375 mg of placebo every 2 or 4 weeks for 12 or 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 700- 2000 IU/mL) group received doses of 450 mg, 525 mg, or 600 mg of placebo every 2 weeks for 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 301- 699 IU/mL) group received doses of 225 mg to 375 mg of placebo every 2 weeks for 6 weeks.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
36 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
29 years
STANDARD_DEVIATION 11.0 • n=7 Participants
|
26 years
STANDARD_DEVIATION 6.0 • n=5 Participants
|
34 years
STANDARD_DEVIATION 10.4 • n=4 Participants
|
32 years
STANDARD_DEVIATION 10.9 • n=21 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Week 8, Week 16Population: Safety and Pharmacodynamic (PD) population. Although all patients had baseline EAR not all of them had a value determined for week 8 and 16 reducing the number evaluable for analysis particularly at week 8. Patients of first 2 Xolair groups received placebo treatment were pooled in one placebo group for analysis. No analysis on third Xolair groups.
The EAR was defined as the maximum percent drop in forced expiratory volume in one second (FEV1) in the first 30 minutes after the challenge: EAR = 100\* \[ FEV1 (0) - Minimum FEV1 (10, 15, 30 min)\] / FEV1 (0). For FEV1 (0), the "best post saline (Control) FEV1" was used. The EAR was analyzed using a linear (ANCOVA) model with a fixed effect for treatment groups and the EAR from the baseline challenge was used as a covariate.
Outcome measures
| Measure |
Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL)
n=18 Participants
Patients with screening Immunoglobulin E (IgE) levels = 30-300 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
|
Xolair (Immunoglobulin E (IgE) = 700- 2000 IU/mL)
n=16 Participants
Patients with screening Immunoglobulin E (IgE) levels = 700- 2000 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight.
|
Placebo Comparator
n=16 Participants
By subcutaneous injection of a solution with a concentration of 125 mg/mL placebo in a supine position: Patients in Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL) group received doses of 150 mg to 375 mg of placebo every 2 or 4 weeks for 12 or 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 700- 2000 IU/mL) group received doses of 450 mg, 525 mg, or 600 mg of placebo every 2 weeks for 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 301- 699 IU/mL) group received doses of 225 mg to 375 mg of placebo every 2 weeks for 6 weeks.
|
|---|---|---|---|
|
Early Phase Allergic Response After Treatment With Study Drug in Active and Placebo Patients
Week 16 (n=14, 15, 15)
|
11.8 Percentage of EAR
Standard Error 3.81
|
5.1 Percentage of EAR
Standard Error 2.02
|
20.0 Percentage of EAR
Standard Error 2.43
|
|
Early Phase Allergic Response After Treatment With Study Drug in Active and Placebo Patients
Week 8 (n=12, 12, 13)
|
9.3 Percentage of EAR
Standard Error 3.97
|
5.6 Percentage of EAR
Standard Error 2.07
|
23.1 Percentage of EAR
Standard Error 3.57
|
SECONDARY outcome
Timeframe: Week 0, Week 8 and Week 16Population: Safety and Pharmacodynamic (PD) population. Although all patients had baseline EAR not all of them had a value determined for week 8 and 16 reducing the number evaluable for analysis particularly at week 8. Patients of first 2 Xolair groups received placebo treatment were pooled in one placebo group for analysis. No analysis on third Xolair groups.
Late-phase allergic response (LAR) was only determined for those patients who had an LAR \>= 15% at baseline allergen bronchoprovocation testing. For Forced Expiratory Volume, FEV1 (0), the "best post saline (Control) FEV1" was used. LAR (%) = 100\*\[FEV1 (0) - Minimum FEV1 (3-8h)\]/FEV1 (0).
Outcome measures
| Measure |
Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL)
n=18 Participants
Patients with screening Immunoglobulin E (IgE) levels = 30-300 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
|
Xolair (Immunoglobulin E (IgE) = 700- 2000 IU/mL)
n=16 Participants
Patients with screening Immunoglobulin E (IgE) levels = 700- 2000 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight.
|
Placebo Comparator
n=16 Participants
By subcutaneous injection of a solution with a concentration of 125 mg/mL placebo in a supine position: Patients in Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL) group received doses of 150 mg to 375 mg of placebo every 2 or 4 weeks for 12 or 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 700- 2000 IU/mL) group received doses of 450 mg, 525 mg, or 600 mg of placebo every 2 weeks for 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 301- 699 IU/mL) group received doses of 225 mg to 375 mg of placebo every 2 weeks for 6 weeks.
|
|---|---|---|---|
|
Late Phase Allergic Response After Treatment With Study Drug in Active and Placebo Patients
Week 16 (n=7, 2, 4)
|
0.23 Percentage of LAR
Standard Deviation 7.109
|
1.5 Percentage of LAR
Standard Deviation 1.53
|
12.3 Percentage of LAR
Standard Deviation 7.09
|
|
Late Phase Allergic Response After Treatment With Study Drug in Active and Placebo Patients
Week 0 (n=8, 3, 5)
|
22.5 Percentage of LAR
Standard Deviation 6.12
|
25.7 Percentage of LAR
Standard Deviation 12.62
|
27.4 Percentage of LAR
Standard Deviation 7.27
|
|
Late Phase Allergic Response After Treatment With Study Drug in Active and Placebo Patients
Week 8 (n=6, 1, 3)
|
5.3 Percentage of LAR
Standard Deviation 12.13
|
-3.5 Percentage of LAR
Standard Deviation 0.0
|
19.1 Percentage of LAR
Standard Deviation 13.42
|
Adverse Events
Xolair (IgE= 30- 300 IU/mL)
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Xolair (IgE= 700- 2000 IU/mL)
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Xolair (IgE= 301- 699 IU/mL)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo Comparator
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Xolair (IgE= 30- 300 IU/mL)
n=18 participants at risk
Patients with screening IgE levels= 30-300 IU/mL. Participants received subcutaneous injections of Xolair(Omalizumab) every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
|
Xolair (IgE= 700- 2000 IU/mL)
n=16 participants at risk
Patients with screening IgE levels= 700- 2000 IU/mL. Participants received subcutaneous injections of Xolair(Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight.
|
Xolair (IgE= 301- 699 IU/mL)
n=10 participants at risk
Patients with screening IgE levels= 301- 699 IU/mL. Participants received subcutaneous injections of Xolair(Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight.
|
Placebo Comparator
n=16 participants at risk
Placebo comparator
|
|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
6.2%
1/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papilloma
|
5.6%
1/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
Other adverse events
| Measure |
Xolair (IgE= 30- 300 IU/mL)
n=18 participants at risk
Patients with screening IgE levels= 30-300 IU/mL. Participants received subcutaneous injections of Xolair(Omalizumab) every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
|
Xolair (IgE= 700- 2000 IU/mL)
n=16 participants at risk
Patients with screening IgE levels= 700- 2000 IU/mL. Participants received subcutaneous injections of Xolair(Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight.
|
Xolair (IgE= 301- 699 IU/mL)
n=10 participants at risk
Patients with screening IgE levels= 301- 699 IU/mL. Participants received subcutaneous injections of Xolair(Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight.
|
Placebo Comparator
n=16 participants at risk
Placebo comparator
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Tooth injury
|
0.00%
0/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
6.2%
1/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
Injury, poisoning and procedural complications
Wound complication
|
5.6%
1/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
Investigations
Blood pressure diastolic increased
|
0.00%
0/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
6.2%
1/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
6.2%
1/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
6.2%
1/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
6.2%
1/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
Ear and labyrinth disorders
Vertigo
|
11.1%
2/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
6.2%
1/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
Eye disorders
Conjunctivitis
|
5.6%
1/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
10.0%
1/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
12.5%
2/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
20.0%
2/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
Eye disorders
Eye irritation
|
5.6%
1/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
Eye disorders
Eye pruritus
|
5.6%
1/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
6.2%
1/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
6.2%
1/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
6.2%
1/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
6.2%
1/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
6.2%
1/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
6.2%
1/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
6.2%
1/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
6.2%
1/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
Gastrointestinal disorders
Toothache
|
5.6%
1/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
6.2%
1/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
General disorders
Fatigue
|
0.00%
0/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
6.2%
1/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
12.5%
2/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
General disorders
Infusion site erythema
|
5.6%
1/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
12.5%
2/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
General disorders
Infusion site haematoma
|
0.00%
0/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
6.2%
1/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
General disorders
Infusion site induration
|
0.00%
0/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
6.2%
1/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
General disorders
Infusion site irritation
|
0.00%
0/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
10.0%
1/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
General disorders
Infusion site swelling
|
0.00%
0/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
6.2%
1/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
General disorders
Infusion site warmth
|
0.00%
0/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
6.2%
1/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
General disorders
Injection site pain
|
0.00%
0/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
6.2%
1/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
6.2%
1/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
General disorders
Injection site swelling
|
5.6%
1/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
12.5%
2/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
General disorders
Pyrexia
|
0.00%
0/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
6.2%
1/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
20.0%
2/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
6.2%
1/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
Infections and infestations
Eczema infected
|
0.00%
0/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
6.2%
1/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
Infections and infestations
Herpes virus infection
|
5.6%
1/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
6.2%
1/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
Infections and infestations
Infectious mononucleosis
|
0.00%
0/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
6.2%
1/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
6.2%
1/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
Infections and infestations
Nasopharyngitis
|
16.7%
3/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
31.2%
5/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
10.0%
1/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
25.0%
4/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
12.5%
2/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
6.2%
1/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
Infections and infestations
Oral infection
|
0.00%
0/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
6.2%
1/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
10.0%
1/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
Infections and infestations
Pilonidal cyst
|
0.00%
0/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
6.2%
1/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
6.2%
1/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
6.2%
1/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
12.5%
2/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
6.2%
1/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
6.2%
1/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
10.0%
1/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
12.5%
2/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
6.2%
1/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
6.2%
1/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
Infections and infestations
Viral infection
|
5.6%
1/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
6.2%
1/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
6.2%
1/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
6.2%
1/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
Investigations
Blood pressure systolic increased
|
0.00%
0/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
6.2%
1/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
6.2%
1/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
Musculoskeletal and connective tissue disorders
Myosclerosis
|
0.00%
0/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
6.2%
1/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
6.2%
1/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
6.2%
1/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
6.2%
1/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
Nervous system disorders
Headache
|
22.2%
4/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
31.2%
5/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
10.0%
1/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
18.8%
3/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
6.2%
1/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
6.2%
1/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
6.2%
1/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
12.5%
2/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
6.2%
1/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
6.2%
1/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.6%
1/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
10.0%
1/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
12.5%
2/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.6%
1/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
10.0%
1/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
6.2%
1/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
6.2%
1/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
6.2%
1/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
12.5%
2/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
6.2%
1/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
12.5%
2/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
6.2%
1/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
Skin and subcutaneous tissue disorders
Dermographism
|
0.00%
0/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
6.2%
1/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
Skin and subcutaneous tissue disorders
Neurodermatitis
|
0.00%
0/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
6.2%
1/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
6.2%
1/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
6.2%
1/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
6.2%
1/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
|
Vascular disorders
Hypertension
|
5.6%
1/18 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/10 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
0.00%
0/16 • 18- 26 weeks. Patients were dosed for 6 - 14 weeks depending on treatment group and adverse event data was collected until final study completion evaluation 12 weeks following last dose.
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER