Trial Outcomes & Findings for Safety/Efficacy Study of Imprime PGG With Cetuximab in Patients With Recurrent/Progressive Colorectal Carcinoma (NCT NCT00545545)
NCT ID: NCT00545545
Last Updated: 2025-03-19
Results Overview
Safety and maximum tolerated dosage (MTD) of Imprime PGG was determined by the Adverse Events Task Force based on the drug-related adverse events experienced by subjects that met the criteria for a dose limiting toxicity (DLT) within a timeframe of the first 3 weeks of treatment and 1 week follow-up. If one in the initial three subjects for a dose group experienced a DLT, three additional subjects were enrolled in that dose group. If two or more subjects in the expanded dose group experienced a DLT, the study was to be stopped and the MTD was defined as the dose prior to the dose at which the DLT was observed. If a DLT occurred in the first dose group (2 mg/kg Imprime PGG), the protocol allowed for the next group to be dosed at a reduced dose of 1 mg/kg Imprime PGG. The dose groups described above were: Dose Group 1 (Imprime PGG 2 mg/kg), Dose Group 2 (Imprime PGG 4 mg/kg), Dose Group 3 (Imprime PGG 6 mg/kg).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
32 participants
Primary outcome timeframe
From the date of the first dose of study drug to disease progression or until development of a drug toxicity that precludes further protocol treatment, up to 15 months
Results posted on
2025-03-19
Participant Flow
A phase 1b/2 dose-escalating (ascending dose model) design with 10 subjects enrolled in stage 1, 22 additional subjects in stage 2, for a total of 32 subjects enrolled sequentially into two treatment arms across Southeast Asia clinical sites. First subject enrolled: 15 Oct 2007 Last subject last visit: 04 Nov 2009
A total of 32 participants enrolled, all participants received at least one dose of study treatment.
Participant milestones
| Measure |
Arm 1, Imprime PGG Injection 2 mg/kg+ Cetuximab + Irinotecan
Imprime PGG® infusion:
2 mg/kg i.v. over 1 hr on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Irinotecan infusion:
125 mg/m2 i.v. over 1.5 hours on Days 1, 8, 15, and 22 of each 6-week treatment cycle
|
Arm 1, Imprime PGG Injection 4 mg/kg+ Cetuximab + Irinotecan
Imprime PGG® infusion:
4 mg/kg i.v. over 2 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Irinotecan infusion:
125 mg/m2 i.v. over 1.5 hours on Days 1, 8, 15, and 22 of each 6-week treatment cycle
|
Arm 1, Imprime PGG Injection 6 mg/kg+ Cetuximab + Irinotecan
Imprime PGG® infusion:
6 mg/kg i.v. over 3 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Irinotecan infusion:
125 mg/m2 i.v. over 1.5 hours on Days 1, 8, 15, and 22 of each 6-week treatment cycle
|
Arm 2, Imprime PGG Injection 2 mg/kg+ Cetuximab
Imprime PGG® infusion:
2 mg/kg i.v. over 1 hr on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle
|
Arm 2, Imprime PGG Injection 4 mg/kg+ Cetuximab
Imprime PGG® infusion:
4 mg/kg i.v. over 2 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle
|
Arm 2, Imprime PGG Injection 6 mg/kg+ Cetuximab
Imprime PGG® infusion:
6 mg/kg i.v. over 3 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
7
|
0
|
4
|
9
|
9
|
|
Overall Study
Discontinued
|
3
|
7
|
0
|
4
|
9
|
9
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
7
|
0
|
4
|
9
|
9
|
Reasons for withdrawal
| Measure |
Arm 1, Imprime PGG Injection 2 mg/kg+ Cetuximab + Irinotecan
Imprime PGG® infusion:
2 mg/kg i.v. over 1 hr on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Irinotecan infusion:
125 mg/m2 i.v. over 1.5 hours on Days 1, 8, 15, and 22 of each 6-week treatment cycle
|
Arm 1, Imprime PGG Injection 4 mg/kg+ Cetuximab + Irinotecan
Imprime PGG® infusion:
4 mg/kg i.v. over 2 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Irinotecan infusion:
125 mg/m2 i.v. over 1.5 hours on Days 1, 8, 15, and 22 of each 6-week treatment cycle
|
Arm 1, Imprime PGG Injection 6 mg/kg+ Cetuximab + Irinotecan
Imprime PGG® infusion:
6 mg/kg i.v. over 3 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Irinotecan infusion:
125 mg/m2 i.v. over 1.5 hours on Days 1, 8, 15, and 22 of each 6-week treatment cycle
|
Arm 2, Imprime PGG Injection 2 mg/kg+ Cetuximab
Imprime PGG® infusion:
2 mg/kg i.v. over 1 hr on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle
|
Arm 2, Imprime PGG Injection 4 mg/kg+ Cetuximab
Imprime PGG® infusion:
4 mg/kg i.v. over 2 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle
|
Arm 2, Imprime PGG Injection 6 mg/kg+ Cetuximab
Imprime PGG® infusion:
6 mg/kg i.v. over 3 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle
|
|---|---|---|---|---|---|---|
|
Overall Study
Progressive Neoplastic Disease
|
1
|
5
|
0
|
4
|
8
|
7
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Irinotecan intolerance
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
No target lesions to track post surgery
|
0
|
0
|
0
|
0
|
1
|
1
|
Baseline Characteristics
Safety/Efficacy Study of Imprime PGG With Cetuximab in Patients With Recurrent/Progressive Colorectal Carcinoma
Baseline characteristics by cohort
| Measure |
Arm 1, Imprime PGG Injection 2 mg/kg+ Cetuximab + Irinotecan
n=3 Participants
Imprime PGG® infusion:
2 mg/kg i.v. over 1 hr on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Irinotecan infusion:
125 mg/m2 i.v. over 1.5 hours on Days 1, 8, 15, and 22 of each 6-week treatment cycle
|
Arm 1, Imprime PGG Injection 4 mg/kg+ Cetuximab + Irinotecan
n=7 Participants
Imprime PGG® infusion:
4 mg/kg i.v. over 2 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Irinotecan infusion:
125 mg/m2 i.v. over 1.5 hours on Days 1, 8, 15, and 22 of each 6-week treatment cycle
|
Arm 1, Imprime PGG Injection 6 mg/kg+ Cetuximab + Irinotecan
Imprime PGG® infusion:
6 mg/kg i.v. over 3 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Irinotecan infusion:
125 mg/m2 i.v. over 1.5 hours on Days 1, 8, 15, and 22 of each 6-week treatment cycle
|
Arm 2, Imprime PGG Injection 2 mg/kg+ Cetuximab
n=4 Participants
Imprime PGG® infusion:
2 mg/kg i.v. over 1 hr on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle
|
Arm 2, Imprime PGG Injection 4 mg/kg+ Cetuximab
n=9 Participants
Imprime PGG® infusion:
4 mg/kg i.v. over 2 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle
|
Arm 2, Imprime PGG Injection 6 mg/kg+ Cetuximab
n=9 Participants
Imprime PGG® infusion:
6 mg/kg i.v. over 3 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
57.0 years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
52.9 years
STANDARD_DEVIATION 12.4 • n=7 Participants
|
—
|
52.0 years
STANDARD_DEVIATION 10.8 • n=4 Participants
|
52.6 years
STANDARD_DEVIATION 11.8 • n=21 Participants
|
61.9 years
STANDARD_DEVIATION 9.3 • n=8 Participants
|
55.2 years
STANDARD_DEVIATION 10.9 • n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
22 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
East Southeast Asian
|
3 participants
n=5 Participants
|
7 participants
n=7 Participants
|
—
|
4 participants
n=4 Participants
|
9 participants
n=21 Participants
|
9 participants
n=8 Participants
|
32 participants
n=8 Participants
|
|
Baseline Karnofsky Performance Status Score
|
86.7 units on a scale
STANDARD_DEVIATION 15.3 • n=5 Participants
|
92.9 units on a scale
STANDARD_DEVIATION 7.6 • n=7 Participants
|
—
|
92.5 units on a scale
STANDARD_DEVIATION 5.0 • n=4 Participants
|
90.0 units on a scale
STANDARD_DEVIATION 7.1 • n=21 Participants
|
93.3 units on a scale
STANDARD_DEVIATION 8.7 • n=8 Participants
|
91.4 units on a scale
STANDARD_DEVIATION 8.6 • n=8 Participants
|
|
Baseline Height
|
168.3 cm
STANDARD_DEVIATION 4.2 • n=5 Participants
|
162.3 cm
STANDARD_DEVIATION 11.6 • n=7 Participants
|
—
|
163.3 cm
STANDARD_DEVIATION 7.5 • n=4 Participants
|
161.8 cm
STANDARD_DEVIATION 9.0 • n=21 Participants
|
162.1 cm
STANDARD_DEVIATION 8.5 • n=8 Participants
|
163.2 cm
STANDARD_DEVIATION 9.1 • n=8 Participants
|
|
Baseline Weight
|
69.5 kg
STANDARD_DEVIATION 13.1 • n=5 Participants
|
57.0 kg
STANDARD_DEVIATION 15.1 • n=7 Participants
|
—
|
60.2 kg
STANDARD_DEVIATION 11.5 • n=4 Participants
|
57.6 kg
STANDARD_DEVIATION 11.6 • n=21 Participants
|
63.4 kg
STANDARD_DEVIATION 8.4 • n=8 Participants
|
60.7 kg
STANDARD_DEVIATION 12.7 • n=8 Participants
|
|
Baseline Body Surface Area
|
1.8 m^2
STANDARD_DEVIATION 0.2 • n=5 Participants
|
1.6 m^2
STANDARD_DEVIATION 0.3 • n=7 Participants
|
—
|
1.6 m^2
STANDARD_DEVIATION 0.2 • n=4 Participants
|
1.6 m^2
STANDARD_DEVIATION 0.2 • n=21 Participants
|
1.7 m^2
STANDARD_DEVIATION 0.1 • n=8 Participants
|
1.6 m^2
STANDARD_DEVIATION 0.3 • n=8 Participants
|
|
Time Since Initial Tumor Diagnosis
|
630.7 days
STANDARD_DEVIATION 560.7 • n=5 Participants
|
686.6 days
STANDARD_DEVIATION 354.7 • n=7 Participants
|
—
|
710.5 days
STANDARD_DEVIATION 507.7 • n=4 Participants
|
776.7 days
STANDARD_DEVIATION 597.1 • n=21 Participants
|
526.6 days
STANDARD_DEVIATION 335.8 • n=8 Participants
|
666.1 days
STANDARD_DEVIATION 436.1 • n=8 Participants
|
|
Initial Pathologic Diagnosis
Colon Carcinoma
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
—
|
2 participants
n=4 Participants
|
5 participants
n=21 Participants
|
8 participants
n=8 Participants
|
19 participants
n=8 Participants
|
|
Initial Pathologic Diagnosis
Rectum Carcinoma
|
1 participants
n=5 Participants
|
5 participants
n=7 Participants
|
—
|
2 participants
n=4 Participants
|
4 participants
n=21 Participants
|
1 participants
n=8 Participants
|
13 participants
n=8 Participants
|
|
Basis of Diagnosis
Cytology
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
—
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
0 participants
n=8 Participants
|
1 participants
n=8 Participants
|
|
Basis of Diagnosis
Histology
|
3 participants
n=5 Participants
|
7 participants
n=7 Participants
|
—
|
4 participants
n=4 Participants
|
8 participants
n=21 Participants
|
9 participants
n=8 Participants
|
31 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: From the date of the first dose of study drug to disease progression or until development of a drug toxicity that precludes further protocol treatment, up to 15 monthsPopulation: The safety population comprised of all subjects who received any amount of Imprime PGG.
Safety and maximum tolerated dosage (MTD) of Imprime PGG was determined by the Adverse Events Task Force based on the drug-related adverse events experienced by subjects that met the criteria for a dose limiting toxicity (DLT) within a timeframe of the first 3 weeks of treatment and 1 week follow-up. If one in the initial three subjects for a dose group experienced a DLT, three additional subjects were enrolled in that dose group. If two or more subjects in the expanded dose group experienced a DLT, the study was to be stopped and the MTD was defined as the dose prior to the dose at which the DLT was observed. If a DLT occurred in the first dose group (2 mg/kg Imprime PGG), the protocol allowed for the next group to be dosed at a reduced dose of 1 mg/kg Imprime PGG. The dose groups described above were: Dose Group 1 (Imprime PGG 2 mg/kg), Dose Group 2 (Imprime PGG 4 mg/kg), Dose Group 3 (Imprime PGG 6 mg/kg).
Outcome measures
| Measure |
Arm 1, Imprime PGG Injection 2 mg/kg+ Cetuximab + Irinotecan
n=3 Participants
Imprime PGG® infusion:
2 mg/kg i.v. over 1 hr on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Irinotecan infusion:
125 mg/m2 i.v. over 1.5 hours on Days 1, 8, 15, and 22 of each 6-week treatment cycle
|
Arm 1, Imprime PGG Injection 4 mg/kg+ Cetuximab + Irinotecan
n=7 Participants
Imprime PGG® infusion:
4 mg/kg i.v. over 2 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Irinotecan infusion:
125 mg/m2 i.v. over 1.5 hours on Days 1, 8, 15, and 22 of each 6-week treatment cycle
|
Arm 1, Imprime PGG Injection 6 mg/kg+ Cetuximab + Irinotecan
Imprime PGG® infusion:
6 mg/kg i.v. over 3 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Irinotecan infusion:
125 mg/m2 i.v. over 1.5 hours on Days 1, 8, 15, and 22 of each 6-week treatment cycle
|
Arm 2, Imprime PGG Injection 2 mg/kg+ Cetuximab
n=4 Participants
Imprime PGG® infusion:
2 mg/kg i.v. over 1 hr on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle
|
Arm 2, Imprime PGG Injection 4 mg/kg+ Cetuximab
n=9 Participants
Imprime PGG® infusion:
4 mg/kg i.v. over 2 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle
|
Arm 2, Imprime PGG Injection 6 mg/kg+ Cetuximab
n=9 Participants
Imprime PGG® infusion:
6 mg/kg i.v. over 3 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle
|
|---|---|---|---|---|---|---|
|
Safety and Maximum Tolerated Dosage of Imprime PGG When Used in Combination With Cetuximab With or Without Irinotecan Therapy
Subjects Who Received Treatment
|
3 participants
|
7 participants
|
—
|
4 participants
|
9 participants
|
9 participants
|
|
Safety and Maximum Tolerated Dosage of Imprime PGG When Used in Combination With Cetuximab With or Without Irinotecan Therapy
Subjects Who Discontinued the Study
|
3 participants
|
7 participants
|
—
|
4 participants
|
9 participants
|
9 participants
|
SECONDARY outcome
Timeframe: From the date of the first dose of study drug to disease progression or last objective evaluation of the tumor before treatment discontinuation due to any reason, up to 15 monthsPopulation: The ITT population is comprised of all subjects who have been enrolled in the study. All subjects were included in the Safety and ITT populations.
The best observed overall response rates were defined as the number of participants experiencing a best tumor response of either complete response (CR; disappearance of all target lesions), partial response (PR; \>=30% decrease in the sum of diameters of target lesions), stable disease (SD) or progressive disease (PD) based on RECIST criteria v1.0.
Outcome measures
| Measure |
Arm 1, Imprime PGG Injection 2 mg/kg+ Cetuximab + Irinotecan
n=3 Participants
Imprime PGG® infusion:
2 mg/kg i.v. over 1 hr on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Irinotecan infusion:
125 mg/m2 i.v. over 1.5 hours on Days 1, 8, 15, and 22 of each 6-week treatment cycle
|
Arm 1, Imprime PGG Injection 4 mg/kg+ Cetuximab + Irinotecan
n=7 Participants
Imprime PGG® infusion:
4 mg/kg i.v. over 2 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Irinotecan infusion:
125 mg/m2 i.v. over 1.5 hours on Days 1, 8, 15, and 22 of each 6-week treatment cycle
|
Arm 1, Imprime PGG Injection 6 mg/kg+ Cetuximab + Irinotecan
Imprime PGG® infusion:
6 mg/kg i.v. over 3 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Irinotecan infusion:
125 mg/m2 i.v. over 1.5 hours on Days 1, 8, 15, and 22 of each 6-week treatment cycle
|
Arm 2, Imprime PGG Injection 2 mg/kg+ Cetuximab
n=4 Participants
Imprime PGG® infusion:
2 mg/kg i.v. over 1 hr on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle
|
Arm 2, Imprime PGG Injection 4 mg/kg+ Cetuximab
n=9 Participants
Imprime PGG® infusion:
4 mg/kg i.v. over 2 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle
|
Arm 2, Imprime PGG Injection 6 mg/kg+ Cetuximab
n=9 Participants
Imprime PGG® infusion:
6 mg/kg i.v. over 3 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle
|
|---|---|---|---|---|---|---|
|
Rate of Number of Participants With Tumor Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD) in Each Study Arm
Number of participants with best response of CR
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Rate of Number of Participants With Tumor Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD) in Each Study Arm
Number of participants with best response of PR
|
2 Participants
|
1 Participants
|
—
|
0 Participants
|
3 Participants
|
2 Participants
|
|
Rate of Number of Participants With Tumor Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD) in Each Study Arm
Number of participants with best response of SD
|
1 Participants
|
6 Participants
|
—
|
3 Participants
|
3 Participants
|
2 Participants
|
|
Rate of Number of Participants With Tumor Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD) in Each Study Arm
Number of participants with best response of PD
|
0 Participants
|
0 Participants
|
—
|
1 Participants
|
3 Participants
|
4 Participants
|
|
Rate of Number of Participants With Tumor Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD) in Each Study Arm
No information
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From the date of the first dose of study drug to disease progression or last objective evaluation of the tumor before treatment discontinuation due to any reason, up to 15 monthsPopulation: The ITT population is comprised of all subjects who have been enrolled in the study. All subjects were included in the Safety and ITT populations.
The overall response rate was defined as the number of participants experiencing a best tumor response of either complete response (CR; disappearance of all target lesions) or partial response (PR; \>=30% decrease in the sum of diameters of target lesions) based on RECIST criteria v.1.0. Overall response rate (ORR) = CR + PR.
Outcome measures
| Measure |
Arm 1, Imprime PGG Injection 2 mg/kg+ Cetuximab + Irinotecan
n=3 Participants
Imprime PGG® infusion:
2 mg/kg i.v. over 1 hr on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Irinotecan infusion:
125 mg/m2 i.v. over 1.5 hours on Days 1, 8, 15, and 22 of each 6-week treatment cycle
|
Arm 1, Imprime PGG Injection 4 mg/kg+ Cetuximab + Irinotecan
n=7 Participants
Imprime PGG® infusion:
4 mg/kg i.v. over 2 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Irinotecan infusion:
125 mg/m2 i.v. over 1.5 hours on Days 1, 8, 15, and 22 of each 6-week treatment cycle
|
Arm 1, Imprime PGG Injection 6 mg/kg+ Cetuximab + Irinotecan
Imprime PGG® infusion:
6 mg/kg i.v. over 3 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Irinotecan infusion:
125 mg/m2 i.v. over 1.5 hours on Days 1, 8, 15, and 22 of each 6-week treatment cycle
|
Arm 2, Imprime PGG Injection 2 mg/kg+ Cetuximab
n=4 Participants
Imprime PGG® infusion:
2 mg/kg i.v. over 1 hr on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle
|
Arm 2, Imprime PGG Injection 4 mg/kg+ Cetuximab
n=9 Participants
Imprime PGG® infusion:
4 mg/kg i.v. over 2 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle
|
Arm 2, Imprime PGG Injection 6 mg/kg+ Cetuximab
n=9 Participants
Imprime PGG® infusion:
6 mg/kg i.v. over 3 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle
|
|---|---|---|---|---|---|---|
|
Overall Response Rate (ORR) Per RECIST Criteria v1.0 in Each Study Arm
|
2 Participants
|
1 Participants
|
—
|
0 Participants
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From the date of the first dose of study drug to disease progression or last objective evaluation of the tumor before treatment discontinuation due to any reason, up to 15 monthsPopulation: The ITT population is comprised of all subjects who have been enrolled in the study. All subjects were included in the Safety and ITT populations.
The disease control rate was defined as the number of participants experiencing a best tumor response of either complete response (CR; disappearance of all target lesions), partial response (PR; \>=30% decrease in the sum of diameters of target lesions) or stable disease (SD) based on RECIST criteria v.1.0. Disease control rate (DCR) = CR + PR + SD.
Outcome measures
| Measure |
Arm 1, Imprime PGG Injection 2 mg/kg+ Cetuximab + Irinotecan
n=3 Participants
Imprime PGG® infusion:
2 mg/kg i.v. over 1 hr on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Irinotecan infusion:
125 mg/m2 i.v. over 1.5 hours on Days 1, 8, 15, and 22 of each 6-week treatment cycle
|
Arm 1, Imprime PGG Injection 4 mg/kg+ Cetuximab + Irinotecan
n=7 Participants
Imprime PGG® infusion:
4 mg/kg i.v. over 2 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Irinotecan infusion:
125 mg/m2 i.v. over 1.5 hours on Days 1, 8, 15, and 22 of each 6-week treatment cycle
|
Arm 1, Imprime PGG Injection 6 mg/kg+ Cetuximab + Irinotecan
Imprime PGG® infusion:
6 mg/kg i.v. over 3 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Irinotecan infusion:
125 mg/m2 i.v. over 1.5 hours on Days 1, 8, 15, and 22 of each 6-week treatment cycle
|
Arm 2, Imprime PGG Injection 2 mg/kg+ Cetuximab
n=4 Participants
Imprime PGG® infusion:
2 mg/kg i.v. over 1 hr on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle
|
Arm 2, Imprime PGG Injection 4 mg/kg+ Cetuximab
n=9 Participants
Imprime PGG® infusion:
4 mg/kg i.v. over 2 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle
|
Arm 2, Imprime PGG Injection 6 mg/kg+ Cetuximab
n=9 Participants
Imprime PGG® infusion:
6 mg/kg i.v. over 3 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle
|
|---|---|---|---|---|---|---|
|
Disease Control Rate (DCR) Per RECIST Criteria v1.0 in Each Study Arm
|
3 Participants
|
7 Participants
|
—
|
3 Participants
|
6 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: The time from the date of the first dose of study drug to the date of the first documented progression or last objective evaluation of the tumor before treatment discontinuation due to any reason, up to 15 monthsPopulation: The ITT population is comprised of all subjects who have been enrolled in the study. All subjects were included in the Safety and ITT populations.
Time-to-progression (TTP) was defined as the time from the date of the first dose of study drug to the date of the first documented progression (date of the CT scan where progression was first observed; or where progression was first observed if clinical assessment). Subjects who did not progress were censored at the last objective evaluation (the date of the last CT scan; or last observed clinical assessment).
Outcome measures
| Measure |
Arm 1, Imprime PGG Injection 2 mg/kg+ Cetuximab + Irinotecan
n=3 Participants
Imprime PGG® infusion:
2 mg/kg i.v. over 1 hr on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Irinotecan infusion:
125 mg/m2 i.v. over 1.5 hours on Days 1, 8, 15, and 22 of each 6-week treatment cycle
|
Arm 1, Imprime PGG Injection 4 mg/kg+ Cetuximab + Irinotecan
n=7 Participants
Imprime PGG® infusion:
4 mg/kg i.v. over 2 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Irinotecan infusion:
125 mg/m2 i.v. over 1.5 hours on Days 1, 8, 15, and 22 of each 6-week treatment cycle
|
Arm 1, Imprime PGG Injection 6 mg/kg+ Cetuximab + Irinotecan
Imprime PGG® infusion:
6 mg/kg i.v. over 3 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Irinotecan infusion:
125 mg/m2 i.v. over 1.5 hours on Days 1, 8, 15, and 22 of each 6-week treatment cycle
|
Arm 2, Imprime PGG Injection 2 mg/kg+ Cetuximab
n=4 Participants
Imprime PGG® infusion:
2 mg/kg i.v. over 1 hr on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle
|
Arm 2, Imprime PGG Injection 4 mg/kg+ Cetuximab
n=9 Participants
Imprime PGG® infusion:
4 mg/kg i.v. over 2 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle
|
Arm 2, Imprime PGG Injection 6 mg/kg+ Cetuximab
n=9 Participants
Imprime PGG® infusion:
6 mg/kg i.v. over 3 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle
|
|---|---|---|---|---|---|---|
|
Duration of Time-to-Progression (TTP) in Each Study Arm
|
204.0 days
Interval 166.0 to 204.0
|
148.0 days
Interval 131.0 to 194.0
|
—
|
101.5 days
Interval 19.0 to 212.0
|
163.0 days
Interval 46.0 to 208.0
|
61.0 days
Interval 38.0 to 250.0
|
SECONDARY outcome
Timeframe: The time from the date of the first dose of study drug to the date of the first documented progression or last objective evaluation of the tumor before treatment discontinuation due to any reason, up to 15 monthsPopulation: The ITT population is comprised of all subjects who have been enrolled in the study. All subjects were included in the Safety and ITT populations.
The duration of objective tumor response was defined as the time from the date of the first documented CT scan showing CR (disappearance of all target lesions) or PR (\>=30% decrease in the sum of diameters of target lesions), whichever occurred first, to the date of the first documented progression (date of CT scan where PD was first observed; or where progression was first observed if based on a clinical assessment).
Outcome measures
| Measure |
Arm 1, Imprime PGG Injection 2 mg/kg+ Cetuximab + Irinotecan
n=3 Participants
Imprime PGG® infusion:
2 mg/kg i.v. over 1 hr on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Irinotecan infusion:
125 mg/m2 i.v. over 1.5 hours on Days 1, 8, 15, and 22 of each 6-week treatment cycle
|
Arm 1, Imprime PGG Injection 4 mg/kg+ Cetuximab + Irinotecan
n=7 Participants
Imprime PGG® infusion:
4 mg/kg i.v. over 2 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Irinotecan infusion:
125 mg/m2 i.v. over 1.5 hours on Days 1, 8, 15, and 22 of each 6-week treatment cycle
|
Arm 1, Imprime PGG Injection 6 mg/kg+ Cetuximab + Irinotecan
Imprime PGG® infusion:
6 mg/kg i.v. over 3 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Irinotecan infusion:
125 mg/m2 i.v. over 1.5 hours on Days 1, 8, 15, and 22 of each 6-week treatment cycle
|
Arm 2, Imprime PGG Injection 2 mg/kg+ Cetuximab
n=4 Participants
Imprime PGG® infusion:
2 mg/kg i.v. over 1 hr on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle
|
Arm 2, Imprime PGG Injection 4 mg/kg+ Cetuximab
n=9 Participants
Imprime PGG® infusion:
4 mg/kg i.v. over 2 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle
|
Arm 2, Imprime PGG Injection 6 mg/kg+ Cetuximab
n=9 Participants
Imprime PGG® infusion:
6 mg/kg i.v. over 3 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle
|
|---|---|---|---|---|---|---|
|
Duration of Overall Tumor Response in Each Study Arm
|
149.5 days
Interval 141.0 to 158.0
|
411.0 days
Interval 141.0 to 411.0
|
—
|
0 days
Interval 0.0 to 0.0
|
171.5 days
Interval 169.0 to 174.0
|
99.0 days
Interval 99.0 to 174.0
|
SECONDARY outcome
Timeframe: The time from the date of first dose of study drug to the date of first documented progression, or last objective evaluation of the tumor before treatment discontinuation due to any reason, up to 15 monthsPopulation: The ITT population is comprised of all subjects who have been enrolled in the study. All subjects were included in the Safety and ITT populations.
Duration of stable disease (SD) was to be an efficacy variable, however, duration of disease control was used in place of duration of stable disease, as it is a more clinically meaning measure of the effectiveness of the treatment. Duration of disease control was defined as the time from the date of the first documented CT scan showing CR (disappearance of all target lesions), PR (\>=30% decrease in the sum of diameters of target lesions) or SD, whichever occurred first, to the date of the first documented progression (date of CT scan where PD was first observed; or where progression was first observed if based on a clinical assessment).
Outcome measures
| Measure |
Arm 1, Imprime PGG Injection 2 mg/kg+ Cetuximab + Irinotecan
n=3 Participants
Imprime PGG® infusion:
2 mg/kg i.v. over 1 hr on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Irinotecan infusion:
125 mg/m2 i.v. over 1.5 hours on Days 1, 8, 15, and 22 of each 6-week treatment cycle
|
Arm 1, Imprime PGG Injection 4 mg/kg+ Cetuximab + Irinotecan
n=7 Participants
Imprime PGG® infusion:
4 mg/kg i.v. over 2 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Irinotecan infusion:
125 mg/m2 i.v. over 1.5 hours on Days 1, 8, 15, and 22 of each 6-week treatment cycle
|
Arm 1, Imprime PGG Injection 6 mg/kg+ Cetuximab + Irinotecan
Imprime PGG® infusion:
6 mg/kg i.v. over 3 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Irinotecan infusion:
125 mg/m2 i.v. over 1.5 hours on Days 1, 8, 15, and 22 of each 6-week treatment cycle
|
Arm 2, Imprime PGG Injection 2 mg/kg+ Cetuximab
n=4 Participants
Imprime PGG® infusion:
2 mg/kg i.v. over 1 hr on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle
|
Arm 2, Imprime PGG Injection 4 mg/kg+ Cetuximab
n=9 Participants
Imprime PGG® infusion:
4 mg/kg i.v. over 2 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle
|
Arm 2, Imprime PGG Injection 6 mg/kg+ Cetuximab
n=9 Participants
Imprime PGG® infusion:
6 mg/kg i.v. over 3 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle
|
|---|---|---|---|---|---|---|
|
Duration of Disease Control in Each Study Arm
|
149.5 days
Interval 141.0 to 158.0
|
93.5 days
Interval 78.0 to 147.0
|
—
|
85.0 days
Interval 39.0 to 172.0
|
148.0 days
Interval 127.0 to 174.0
|
99.0 days
Interval 43.0 to 211.0
|
Adverse Events
Arm 1, Imprime PGG Injection 2 mg/kg+ Cetuximab + Irinotecan
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm 1, Imprime PGG Injection 4 mg/kg+ Cetuximab + Irinotecan
Serious events: 6 serious events
Other events: 7 other events
Deaths: 0 deaths
Arm 1, Imprime PGG Injection 6 mg/kg+ Cetuximab + Irinotecan
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2, Imprime PGG Injection 2 mg/kg+ Cetuximab
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Arm 2, Imprime PGG Injection 4 mg/kg+ Cetuximab
Serious events: 4 serious events
Other events: 9 other events
Deaths: 0 deaths
Arm 2, Imprime PGG Injection 6 mg/kg+ Cetuximab
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1, Imprime PGG Injection 2 mg/kg+ Cetuximab + Irinotecan
n=3 participants at risk
Imprime PGG® infusion:
2 mg/kg i.v. over 1 hr on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Irinotecan infusion:
125 mg/m2 i.v. over 1.5 hours on Days 1, 8, 15, and 22 of each 6-week treatment cycle
|
Arm 1, Imprime PGG Injection 4 mg/kg+ Cetuximab + Irinotecan
n=7 participants at risk
Imprime PGG® infusion:
4 mg/kg i.v. over 2 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Irinotecan infusion:
125 mg/m2 i.v. over 1.5 hours on Days 1, 8, 15, and 22 of each 6-week treatment cycle
|
Arm 1, Imprime PGG Injection 6 mg/kg+ Cetuximab + Irinotecan
Imprime PGG® infusion:
6 mg/kg i.v. over 3 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Irinotecan infusion:
125 mg/m2 i.v. over 1.5 hours on Days 1, 8, 15, and 22 of each 6-week treatment cycle
|
Arm 2, Imprime PGG Injection 2 mg/kg+ Cetuximab
n=4 participants at risk
Imprime PGG® infusion:
2 mg/kg i.v. over 1 hr on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle
|
Arm 2, Imprime PGG Injection 4 mg/kg+ Cetuximab
n=9 participants at risk
Imprime PGG® infusion:
4 mg/kg i.v. over 2 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle
|
Arm 2, Imprime PGG Injection 6 mg/kg+ Cetuximab
n=9 participants at risk
Imprime PGG® infusion:
6 mg/kg i.v. over 3 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
22.2%
2/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Blood and lymphatic system disorders
Neutropenia
|
66.7%
2/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
28.6%
2/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Gastrointestinal disorders
Diarrhoea
|
66.7%
2/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
42.9%
3/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Gastrointestinal disorders
Gastritis
|
33.3%
1/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
33.3%
1/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Gastrointestinal disorders
Perianal abscess
|
33.3%
1/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Hepatobiliary disorders
Hepatic mass
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Infections and infestations
Hepatitis viral
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Infections and infestations
Pneumonia
|
33.3%
1/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Investigations
Blood amylase increased
|
66.7%
2/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Investigations
Gamma-glutamyltransferase increased
|
33.3%
1/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Investigations
International normalized ratio increased
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Investigations
Lipase increased
|
33.3%
1/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
1/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Metabolism and nutrition disorders
Dehydration
|
66.7%
2/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
28.6%
2/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
33.3%
1/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
28.6%
2/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Nervous system disorders
Familial periodic paralysis
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
33.3%
1/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
Other adverse events
| Measure |
Arm 1, Imprime PGG Injection 2 mg/kg+ Cetuximab + Irinotecan
n=3 participants at risk
Imprime PGG® infusion:
2 mg/kg i.v. over 1 hr on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Irinotecan infusion:
125 mg/m2 i.v. over 1.5 hours on Days 1, 8, 15, and 22 of each 6-week treatment cycle
|
Arm 1, Imprime PGG Injection 4 mg/kg+ Cetuximab + Irinotecan
n=7 participants at risk
Imprime PGG® infusion:
4 mg/kg i.v. over 2 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Irinotecan infusion:
125 mg/m2 i.v. over 1.5 hours on Days 1, 8, 15, and 22 of each 6-week treatment cycle
|
Arm 1, Imprime PGG Injection 6 mg/kg+ Cetuximab + Irinotecan
Imprime PGG® infusion:
6 mg/kg i.v. over 3 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Irinotecan infusion:
125 mg/m2 i.v. over 1.5 hours on Days 1, 8, 15, and 22 of each 6-week treatment cycle
|
Arm 2, Imprime PGG Injection 2 mg/kg+ Cetuximab
n=4 participants at risk
Imprime PGG® infusion:
2 mg/kg i.v. over 1 hr on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle
|
Arm 2, Imprime PGG Injection 4 mg/kg+ Cetuximab
n=9 participants at risk
Imprime PGG® infusion:
4 mg/kg i.v. over 2 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle
|
Arm 2, Imprime PGG Injection 6 mg/kg+ Cetuximab
n=9 participants at risk
Imprime PGG® infusion:
6 mg/kg i.v. over 3 hours on Days 1, 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
Cetuximab infusion:
400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
57.1%
4/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
50.0%
2/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
22.2%
2/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
22.2%
2/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
33.3%
3/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
33.3%
3/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Blood and lymphatic system disorders
Leukpoenia
|
33.3%
1/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
71.4%
5/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Blood and lymphatic system disorders
Neutropenia
|
66.7%
2/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
85.7%
6/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Cardiac disorders
Arrhythmia
|
33.3%
1/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Cardiac disorders
Hypotension
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Cardiac disorders
Myocardial ischemia
|
33.3%
1/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Cardiac disorders
Tachycardia
|
33.3%
1/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Ear and labyrinth disorders
Otitis externa
|
33.3%
1/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Eye disorders
Blepharitis
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Eye disorders
Conjunctival cyst
|
33.3%
1/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Eye disorders
Erythema of eyelid
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Eye disorders
Ocular surface disease
|
33.3%
1/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Gastrointestinal disorders
Abdominal distension
|
66.7%
2/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
28.6%
2/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Gastrointestinal disorders
Abdominal pain
|
100.0%
3/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
28.6%
2/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
22.2%
2/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
General disorders
Procedural pain
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
33.3%
1/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
66.7%
2/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
28.6%
2/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Gastrointestinal disorders
Colitis
|
33.3%
1/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
42.9%
3/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
22.2%
2/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Gastrointestinal disorders
Diarrhoea
|
100.0%
3/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
85.7%
6/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
22.2%
2/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Gastrointestinal disorders
Ileus
|
33.3%
1/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Gastrointestinal disorders
Mucosal inflammation
|
33.3%
1/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
28.6%
2/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Gastrointestinal disorders
Perianal abscess
|
33.3%
1/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
General disorders
Pyrexia
|
66.7%
2/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
28.6%
2/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Gastrointestinal disorders
Proctalgia
|
33.3%
1/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Gastrointestinal disorders
Stomatitis
|
66.7%
2/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
42.9%
3/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Gastrointestinal disorders
Vomiting
|
66.7%
2/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
42.9%
3/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
General disorders
Asthenia
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
General disorders
Generalized muscle ache
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
General disorders
Oedema peripheral
|
33.3%
1/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
22.2%
2/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
General disorders
Pain
|
33.3%
1/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
General disorders
Viceral oedema
|
33.3%
1/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
General disorders
Fatigue
|
33.3%
1/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Immune system disorders
Cytokine release syndrome
|
33.3%
1/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Immune system disorders
Hypersensitivity
|
33.3%
1/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Infections and infestations
Nasopharyngitis
|
33.3%
1/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Infections and infestations
Urinary tract infection
|
33.3%
1/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
42.9%
3/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
33.3%
3/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Infections and infestations
Infection
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Investigations
Alanine amniotransferase decreased
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Investigations
Alanine amniotransferase increased
|
33.3%
1/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
57.1%
4/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
75.0%
3/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
55.6%
5/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
33.3%
3/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Investigations
Asparate amniotransferase decreased
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Investigations
Asparate amniotransferase increased
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
57.1%
4/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
50.0%
2/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
66.7%
6/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
44.4%
4/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Investigations
Blood albumin decreased
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
22.2%
2/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
28.6%
2/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
75.0%
3/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
33.3%
3/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
33.3%
3/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Investigations
Blood amylase decreased
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Investigations
Blood amylase increased
|
100.0%
3/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
71.4%
5/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
75.0%
3/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
22.2%
2/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Investigations
Blood bicarbonate decreased
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
33.3%
3/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
44.4%
4/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Investigations
Blood bicarbonate increased
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
22.2%
2/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
22.2%
2/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Investigations
Blood bilirubin increased
|
33.3%
1/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
42.9%
3/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
75.0%
3/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
33.3%
3/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
44.4%
4/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Investigations
Blood calcium decreased
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
22.2%
2/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
22.2%
2/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Investigations
Blood calcium increased
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
22.2%
2/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Investigations
Blood chloride decreased
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
22.2%
2/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Investigations
Blood chloride increased
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
22.2%
2/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
33.3%
3/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
22.2%
2/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Investigations
Blood creatinine increased
|
33.3%
1/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
22.2%
2/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Investigations
Blood glucose increased
|
33.3%
1/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
22.2%
2/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
22.2%
2/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Investigations
Blood magnesium increased
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
22.2%
2/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
22.2%
2/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Investigations
Blood phosphorus increased
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
44.4%
4/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Investigations
Blood potassium increased
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Investigations
Blood sodium decreased
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
22.2%
2/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Investigations
Blood urea decreased
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Investigations
Blood urea increased
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
33.3%
3/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Investigations
Blood urea nitrogen/creatinine ratio decreased
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Investigations
Blood uric acid increased
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
33.3%
3/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
33.3%
3/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Investigations
Creatine phosphokinase decreased
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Investigations
Electrocardiogram poor r-wave progression
|
33.3%
1/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Investigations
Gammaglutamyltransferase increased
|
33.3%
1/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
71.4%
5/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
75.0%
3/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
44.4%
4/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
44.4%
4/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Investigations
Globulins increased
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Investigations
Glucose urine present
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Investigations
Lipase increased
|
33.3%
1/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Investigations
Neutrophil count increased
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
44.4%
4/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
22.2%
2/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Investigations
Platelet count increased
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Investigations
Protein total decreased
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Investigations
Protein total increased
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Investigations
Weight decreased
|
33.3%
1/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
85.7%
6/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Investigations
White blood cell count increased
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
44.4%
4/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
33.3%
3/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Metabolism and nutrition disorders
Anorexia
|
66.7%
2/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
71.4%
5/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
22.2%
2/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
28.6%
2/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Metabolism and nutrition disorders
Hyperbilirubinaemia
|
33.3%
1/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
22.2%
2/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
33.3%
1/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
33.3%
3/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
100.0%
3/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
28.6%
2/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
44.4%
4/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
66.7%
2/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
85.7%
6/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
77.8%
7/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
22.2%
2/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
33.3%
1/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
57.1%
4/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
22.2%
2/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
33.3%
1/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
57.1%
4/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
50.0%
2/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
33.3%
3/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
66.7%
2/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Renal and urinary disorders
Azotaemia
|
33.3%
1/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Renal and urinary disorders
Cystitis
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Renal and urinary disorders
Dysuria
|
33.3%
1/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Renal and urinary disorders
Haematuria
|
66.7%
2/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
57.1%
4/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
33.3%
3/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Renal and urinary disorders
Nephrolithiasis
|
66.7%
2/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Renal and urinary disorders
Nitrate urine present
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Renal and urinary disorders
Renal pain
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Renal and urinary disorders
Urinary retention
|
33.3%
1/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
33.3%
1/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Renal and urinary disorders
Pyuria
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Reproductive system and breast disorders
Genital haemorhage
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
22.2%
2/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
33.3%
1/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
33.3%
1/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Skin and subcutaneous tissue disorders
Acne
|
33.3%
1/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
100.0%
3/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
85.7%
6/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Skin and subcutaneous tissue disorders
Carbuncle
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Skin and subcutaneous tissue disorders
Cutaneous lupus erythematosus
|
33.3%
1/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Skin and subcutaneous tissue disorders
Dermatits acneform
|
33.3%
1/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
42.9%
3/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
75.0%
3/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
88.9%
8/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
77.8%
7/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
66.7%
2/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
42.9%
3/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
66.7%
6/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
22.2%
2/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Skin and subcutaneous tissue disorders
Excoriation
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Skin and subcutaneous tissue disorders
Flushing
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Skin and subcutaneous tissue disorders
Palmar erythema
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythordysaesthesia syndrome
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Skin and subcutaneous tissue disorders
Paronychia
|
33.3%
1/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
66.7%
6/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
22.2%
2/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
66.7%
2/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
1/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
42.9%
3/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
42.9%
3/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
11.1%
1/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
|
Vascular disorders
Phelbitis
|
33.3%
1/3 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
—
0/0 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
0.00%
0/9 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy, through end of treatment, up to 15 months
The reason the number of participants at risk is zero for the 6 mg group in Arm 1 is that no patients were dosed in this group.
|
Additional Information
Michele A. Gargano, MSC/ VP Clin Ops and Prg Mngt
HiberCell
Phone: 651.675.0300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60