Trial Outcomes & Findings for A Study of Administration of Peginterferon Alfa-2a [Pegasys] by Autoinjector Versus Pre-filled Syringe in Patients With Chronic Hepatitis C (NCT NCT01087944)
NCT ID: NCT01087944
Last Updated: 2016-02-09
Results Overview
The feasibility of PEG-INF administration by AI was assessed by Injection Method Observational Survey questions, based on following pre-defined questions using a "Yes" or "No" response: 1) Did the participant exhibit any nervousness prior to the injection? 2) Did the participant exhibit any difficulty initiating the injection? 3) Did the participant appear confident performing the injection? 4) Did the participant follow the instructions for performing the injection without the need for additional instructions or guidance? 5) Did the participant experience any technical problems with the device or syringe during the injection? 6) Did the participant withdraw the device/syringe before the injection was complete? 7) Did the participant exhibit any visible pain or physical discomfort? 8) Did the participant appear to be satisfied using the device or syringe? 9) Did the participant exhibit any frustration using the syringe or device?
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
60 participants
Primary outcome timeframe
Week 1, Day 1 (Baseline), Week 2 (Day 8 ± 2 days), Week 3 (Day 15 ± 2 days), Week 4 (Day 22 ± 2 days), Week 5 (Day 29 ± 2 days), Week 6 (Day 36 ± 2 days)
Results posted on
2016-02-09
Participant Flow
A total of 60 participant's data were included from USA (10 centers). The inclusion period was between 11th March 2010 and 28th May 2010.
This was a two-arm, randomized, crossover study in adult participants with hepatitis C infection. Participants were randomly assigned to one of two groups, in which they received injections by either pre-filled syringe (PFS) or autoinjector (AI) for the first 3 weeks and then switched to the other injection method for an additional 3 weeks.
Participant milestones
| Measure |
Sequence 1 (Auto-Injector Then Pre-filled Syringe)
Participants received Peginterferon alfa-2a (PEG-IFN) 180 microgram (mcg) /0.5 milliliter (mL) subcutaneously once a week using autoinjector from Week 1-3 in Treatment Period 1 and using pre-filled syringe from Week 4-6 in Treatment Period 2.
|
Sequence 2 (Pre-filled Syringe Then Auto-Injector)
Participants received PEG-IFN 180 mcg /0.5 mL subcutaneously once a week using pre-filled syringe from Week 1-3 in Treatment Period 1 and using autoinjector from Week 4-6 in Treatment Period 2.
|
|---|---|---|
|
Period 1 (Week 1-3)
STARTED
|
30
|
30
|
|
Period 1 (Week 1-3)
COMPLETED
|
29
|
30
|
|
Period 1 (Week 1-3)
NOT COMPLETED
|
1
|
0
|
|
Period 2 (Week 4-6)
STARTED
|
29
|
30
|
|
Period 2 (Week 4-6)
COMPLETED
|
29
|
28
|
|
Period 2 (Week 4-6)
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Sequence 1 (Auto-Injector Then Pre-filled Syringe)
Participants received Peginterferon alfa-2a (PEG-IFN) 180 microgram (mcg) /0.5 milliliter (mL) subcutaneously once a week using autoinjector from Week 1-3 in Treatment Period 1 and using pre-filled syringe from Week 4-6 in Treatment Period 2.
|
Sequence 2 (Pre-filled Syringe Then Auto-Injector)
Participants received PEG-IFN 180 mcg /0.5 mL subcutaneously once a week using pre-filled syringe from Week 1-3 in Treatment Period 1 and using autoinjector from Week 4-6 in Treatment Period 2.
|
|---|---|---|
|
Period 1 (Week 1-3)
Adverse Event
|
1
|
0
|
|
Period 2 (Week 4-6)
Adverse Event
|
0
|
2
|
Baseline Characteristics
A Study of Administration of Peginterferon Alfa-2a [Pegasys] by Autoinjector Versus Pre-filled Syringe in Patients With Chronic Hepatitis C
Baseline characteristics by cohort
| Measure |
Overall
n=60 Participants
Participants received PEG-IFN alfa-2a 180 mcg SC once a week either AI or PFS for the first 3 weeks and then switched to the other method of injection for an additional 3 weeks. Participants also received ribavirin according to standard of care per the investigator's judgment.
|
|---|---|
|
Age, Continuous
|
49.5 Years
STANDARD_DEVIATION 10.60 • n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 1, Day 1 (Baseline), Week 2 (Day 8 ± 2 days), Week 3 (Day 15 ± 2 days), Week 4 (Day 22 ± 2 days), Week 5 (Day 29 ± 2 days), Week 6 (Day 36 ± 2 days)Population: The intent-to-treat (ITT) population included all participants who received at least one injection
The feasibility of PEG-INF administration by AI was assessed by Injection Method Observational Survey questions, based on following pre-defined questions using a "Yes" or "No" response: 1) Did the participant exhibit any nervousness prior to the injection? 2) Did the participant exhibit any difficulty initiating the injection? 3) Did the participant appear confident performing the injection? 4) Did the participant follow the instructions for performing the injection without the need for additional instructions or guidance? 5) Did the participant experience any technical problems with the device or syringe during the injection? 6) Did the participant withdraw the device/syringe before the injection was complete? 7) Did the participant exhibit any visible pain or physical discomfort? 8) Did the participant appear to be satisfied using the device or syringe? 9) Did the participant exhibit any frustration using the syringe or device?
Outcome measures
| Measure |
Autoinjector
n=60 Participants
The AI group includes results from Weeks 1-3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1-3, followed by PFS for Weeks 4-6) and results from Weeks 4-6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1-3, followed by AI for Weeks 4-6)
|
Pre-filled Syringe
n=59 Participants
The PFS group includes results from Weeks 1-3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1-3, followed by AI for Weeks 4-6)and results from Weeks 4-6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1-3, followed by PFS for Weeks 4-6)
|
|---|---|---|
|
Feasibility of Peginterferon Alfa-2a Administration by Autoinjector
Injection 1, Nervousness, Yes
|
11 participants
|
14 participants
|
|
Feasibility of Peginterferon Alfa-2a Administration by Autoinjector
Injection 2, Nervousness, Yes
|
0 participants
|
3 participants
|
|
Feasibility of Peginterferon Alfa-2a Administration by Autoinjector
Injection 2, Nervousness, No
|
58 participants
|
56 participants
|
|
Feasibility of Peginterferon Alfa-2a Administration by Autoinjector
Injection 3, Nervousness, Yes
|
1 participants
|
2 participants
|
|
Feasibility of Peginterferon Alfa-2a Administration by Autoinjector
Injection 1, Difficulty initiating, Yes
|
7 participants
|
10 participants
|
|
Feasibility of Peginterferon Alfa-2a Administration by Autoinjector
Injection 1, Difficulty initiating, No
|
53 participants
|
49 participants
|
|
Feasibility of Peginterferon Alfa-2a Administration by Autoinjector
Injection 2, Difficulty initiating, Yes
|
0 participants
|
2 participants
|
|
Feasibility of Peginterferon Alfa-2a Administration by Autoinjector
Injection 2, Difficulty initiating, No
|
58 participants
|
57 participants
|
|
Feasibility of Peginterferon Alfa-2a Administration by Autoinjector
Injection 3, Difficulty initiating, Yes
|
0 participants
|
2 participants
|
|
Feasibility of Peginterferon Alfa-2a Administration by Autoinjector
Injection 3, Difficulty initiating, No
|
57 participants
|
57 participants
|
|
Feasibility of Peginterferon Alfa-2a Administration by Autoinjector
Injection 1, Confidence, Yes
|
58 participants
|
46 participants
|
|
Feasibility of Peginterferon Alfa-2a Administration by Autoinjector
Injection 2, Satisfaction, No
|
0 participants
|
4 participants
|
|
Feasibility of Peginterferon Alfa-2a Administration by Autoinjector
Injection 1, Following instruction, Yes
|
58 participants
|
54 participants
|
|
Feasibility of Peginterferon Alfa-2a Administration by Autoinjector
Injection 1, Following instruction, No
|
2 participants
|
5 participants
|
|
Feasibility of Peginterferon Alfa-2a Administration by Autoinjector
Injection 2, Following instruction, Yes
|
53 participants
|
53 participants
|
|
Feasibility of Peginterferon Alfa-2a Administration by Autoinjector
Injection 2, Following instruction, No
|
5 participants
|
6 participants
|
|
Feasibility of Peginterferon Alfa-2a Administration by Autoinjector
Injection 3, Following instruction, Yes
|
55 participants
|
56 participants
|
|
Feasibility of Peginterferon Alfa-2a Administration by Autoinjector
Injection 3, Following instruction, No
|
2 participants
|
3 participants
|
|
Feasibility of Peginterferon Alfa-2a Administration by Autoinjector
Injection 1, Technical problems, Yes
|
7 participants
|
2 participants
|
|
Feasibility of Peginterferon Alfa-2a Administration by Autoinjector
Injection 1, Technical problems, No
|
53 participants
|
57 participants
|
|
Feasibility of Peginterferon Alfa-2a Administration by Autoinjector
Injection 2, Technical problems, Yes
|
5 participants
|
1 participants
|
|
Feasibility of Peginterferon Alfa-2a Administration by Autoinjector
Injection 2, Technical problems, No
|
53 participants
|
58 participants
|
|
Feasibility of Peginterferon Alfa-2a Administration by Autoinjector
Injection 3, Technical problems, Yes
|
3 participants
|
3 participants
|
|
Feasibility of Peginterferon Alfa-2a Administration by Autoinjector
Injection 3, Technical problems, No
|
54 participants
|
56 participants
|
|
Feasibility of Peginterferon Alfa-2a Administration by Autoinjector
Injection 1, Withdrawal before completion, Yes
|
4 participants
|
0 participants
|
|
Feasibility of Peginterferon Alfa-2a Administration by Autoinjector
Injection 1, Withdrawal before completion, No
|
56 participants
|
59 participants
|
|
Feasibility of Peginterferon Alfa-2a Administration by Autoinjector
Injection 2, Withdrawal before completion, Yes
|
1 participants
|
0 participants
|
|
Feasibility of Peginterferon Alfa-2a Administration by Autoinjector
Injection 2, Withdrawal before completion, No
|
57 participants
|
59 participants
|
|
Feasibility of Peginterferon Alfa-2a Administration by Autoinjector
Injection 3, Withdrawal before completion, Yes
|
0 participants
|
1 participants
|
|
Feasibility of Peginterferon Alfa-2a Administration by Autoinjector
Injection 3, Withdrawal before completion, No
|
57 participants
|
58 participants
|
|
Feasibility of Peginterferon Alfa-2a Administration by Autoinjector
Injection 1, Pain/Discomfort, Yes
|
0 participants
|
2 participants
|
|
Feasibility of Peginterferon Alfa-2a Administration by Autoinjector
Injection 1, Pain/Discomfort, No
|
60 participants
|
57 participants
|
|
Feasibility of Peginterferon Alfa-2a Administration by Autoinjector
Injection 2, Pain/Discomfort, Yes
|
0 participants
|
1 participants
|
|
Feasibility of Peginterferon Alfa-2a Administration by Autoinjector
Injection 2, Pain/Discomfort, No
|
58 participants
|
58 participants
|
|
Feasibility of Peginterferon Alfa-2a Administration by Autoinjector
Injection 3, Pain/Discomfort, Yes
|
0 participants
|
2 participants
|
|
Feasibility of Peginterferon Alfa-2a Administration by Autoinjector
Injection 3, Pain/Discomfort, No
|
57 participants
|
57 participants
|
|
Feasibility of Peginterferon Alfa-2a Administration by Autoinjector
Injection 1, Satisfaction, Yes
|
60 participants
|
51 participants
|
|
Feasibility of Peginterferon Alfa-2a Administration by Autoinjector
Injection 1, Satisfaction, No
|
0 participants
|
8 participants
|
|
Feasibility of Peginterferon Alfa-2a Administration by Autoinjector
Injection 2, Satisfaction, Yes
|
58 participants
|
55 participants
|
|
Feasibility of Peginterferon Alfa-2a Administration by Autoinjector
Injection 3, Satisfaction, Yes
|
57 participants
|
56 participants
|
|
Feasibility of Peginterferon Alfa-2a Administration by Autoinjector
Injection 3, Satisfaction, No
|
0 participants
|
3 participants
|
|
Feasibility of Peginterferon Alfa-2a Administration by Autoinjector
Injection 1, Frustration, Yes
|
1 participants
|
2 participants
|
|
Feasibility of Peginterferon Alfa-2a Administration by Autoinjector
Injection 1, Frustration, No
|
59 participants
|
57 participants
|
|
Feasibility of Peginterferon Alfa-2a Administration by Autoinjector
Injection 2, Frustration, Yes
|
0 participants
|
2 participants
|
|
Feasibility of Peginterferon Alfa-2a Administration by Autoinjector
Injection 2, Frustration, No
|
58 participants
|
57 participants
|
|
Feasibility of Peginterferon Alfa-2a Administration by Autoinjector
Injection 3, Frustration, Yes
|
0 participants
|
2 participants
|
|
Feasibility of Peginterferon Alfa-2a Administration by Autoinjector
Injection 3, Frustration, No
|
57 participants
|
57 participants
|
|
Feasibility of Peginterferon Alfa-2a Administration by Autoinjector
Injection 1, Nervousness, No
|
49 participants
|
45 participants
|
|
Feasibility of Peginterferon Alfa-2a Administration by Autoinjector
Injection 3, Nervousness, No
|
56 participants
|
57 participants
|
|
Feasibility of Peginterferon Alfa-2a Administration by Autoinjector
Injection 1, Confidence, No
|
2 participants
|
13 participants
|
|
Feasibility of Peginterferon Alfa-2a Administration by Autoinjector
Injection 2, Confidence, Yes
|
58 participants
|
57 participants
|
|
Feasibility of Peginterferon Alfa-2a Administration by Autoinjector
Injection 2, Confidence, No
|
0 participants
|
2 participants
|
|
Feasibility of Peginterferon Alfa-2a Administration by Autoinjector
Injection 3, Confidence, Yes
|
57 participants
|
58 participants
|
|
Feasibility of Peginterferon Alfa-2a Administration by Autoinjector
Injection 3, Confidence, No
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)Population: The ITT population included all participants who received at least one injection
A marked abnormality was defined as a test result which was outside of the marked abnormality range, and which represented a clinically relevant change from baseline of at least the designated amount. The marked reference range for hemoglobin was 110-200 (gram per liter \[g/L\]), albumin was 30.0-n.d g/L, and total protein was 55-87 g/L. The clinical relevant change (decrease/ increase) for hemoglobin was (15%, 15%), albumin was (20%, n.d) and total protein was (20%, 20%) respectively.
Outcome measures
| Measure |
Autoinjector
n=60 Participants
The AI group includes results from Weeks 1-3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1-3, followed by PFS for Weeks 4-6) and results from Weeks 4-6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1-3, followed by AI for Weeks 4-6)
|
Pre-filled Syringe
n=59 Participants
The PFS group includes results from Weeks 1-3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1-3, followed by AI for Weeks 4-6)and results from Weeks 4-6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1-3, followed by PFS for Weeks 4-6)
|
|---|---|---|
|
Number of Participants With Marked Laboratory Abnormalities in Hemoglobin, Albumin and Total Protein
High Total Protein (n=58, 58)
|
0 participants
|
0 participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Hemoglobin, Albumin and Total Protein
High Hemoglobin (n=58, 58)
|
1 participants
|
0 participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Hemoglobin, Albumin and Total Protein
Low Hemoglobin (n=58, 58)
|
3 participants
|
3 participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Hemoglobin, Albumin and Total Protein
Low Total Protein (n=58, 58)
|
0 participants
|
0 participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Hemoglobin, Albumin and Total Protein
Low Albumin (n=58, 58)
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)Population: The ITT population included all participants who received at least one injection
A marked abnormality was defined as a test result which was outside of the marked abnormality range, and which represented a clinically relevant change from baseline of at least the designated amount. The marked reference range for hematocrit was 0.31-0.56 fraction. The clinical relevant change (decrease/ increase) for hematocrit was (15%, 15%).
Outcome measures
| Measure |
Autoinjector
n=60 Participants
The AI group includes results from Weeks 1-3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1-3, followed by PFS for Weeks 4-6) and results from Weeks 4-6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1-3, followed by AI for Weeks 4-6)
|
Pre-filled Syringe
n=59 Participants
The PFS group includes results from Weeks 1-3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1-3, followed by AI for Weeks 4-6)and results from Weeks 4-6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1-3, followed by PFS for Weeks 4-6)
|
|---|---|---|
|
Number of Participants With Marked Laboratory Abnormalities in Hematocrit
High Hematocrit (n=58, 58)
|
1 participants
|
0 participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Hematocrit
Low Hematocrit (n=58, 58)
|
3 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)Population: The ITT population included all participants who received at least one injection
A marked abnormality was defined as a test result which was outside of the marked abnormality range, and which represented a clinically relevant change from baseline of at least the designated amount. The marked reference range for Platelets was 100-550 (10\*9/L), for WBC was 3.0-18.0 (10\*9/L), for Basophils was 0.00-0.40 (10\*9/L), for Eosinophil was 0.00-0.90 (10\*9/L), for Lymphocytes was 0.70-7.60 (10\*9/L), Monocyte was 0.00-1.70 (10\*9/L), and Neutrophil 1.50-9.25 (10\*9/L). The clinical relevant change (decrease/increase) for platelet was (30%, 50%), WBC was (30%, 30%), Basophil was (n.d, 100%), Eosinophil was (n.d, 100%), Lymphocyte was (30%, 30%), Monocyte was (n.d, 100%) and Neutrophil was (20%, 20%) respectively.
Outcome measures
| Measure |
Autoinjector
n=60 Participants
The AI group includes results from Weeks 1-3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1-3, followed by PFS for Weeks 4-6) and results from Weeks 4-6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1-3, followed by AI for Weeks 4-6)
|
Pre-filled Syringe
n=59 Participants
The PFS group includes results from Weeks 1-3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1-3, followed by AI for Weeks 4-6)and results from Weeks 4-6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1-3, followed by PFS for Weeks 4-6)
|
|---|---|---|
|
Number of Participants With Marked Laboratory Abnormalities in Platelet, White Blood Cell (WBC), Basophil, Eosinophil, Lymphocyte, Monocyte and Neutrophil
High Platelets (n=57, 58)
|
0 participants
|
0 participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Platelet, White Blood Cell (WBC), Basophil, Eosinophil, Lymphocyte, Monocyte and Neutrophil
Low Platelets (n=57, 58)
|
5 participants
|
3 participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Platelet, White Blood Cell (WBC), Basophil, Eosinophil, Lymphocyte, Monocyte and Neutrophil
High White Blood Cells (n=58, 57)
|
0 participants
|
0 participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Platelet, White Blood Cell (WBC), Basophil, Eosinophil, Lymphocyte, Monocyte and Neutrophil
Low White Blood Cells (n=58, 57)
|
11 participants
|
9 participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Platelet, White Blood Cell (WBC), Basophil, Eosinophil, Lymphocyte, Monocyte and Neutrophil
High Basophil (n=58, 58)
|
0 participants
|
0 participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Platelet, White Blood Cell (WBC), Basophil, Eosinophil, Lymphocyte, Monocyte and Neutrophil
High Eosinophil (n=58, 58)
|
0 participants
|
0 participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Platelet, White Blood Cell (WBC), Basophil, Eosinophil, Lymphocyte, Monocyte and Neutrophil
High Lymphocyte (n=58, 58)
|
0 participants
|
0 participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Platelet, White Blood Cell (WBC), Basophil, Eosinophil, Lymphocyte, Monocyte and Neutrophil
Low Lymphocyte (n=58, 58)
|
5 participants
|
1 participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Platelet, White Blood Cell (WBC), Basophil, Eosinophil, Lymphocyte, Monocyte and Neutrophil
High Monocyte (n=58, 58)
|
0 participants
|
0 participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Platelet, White Blood Cell (WBC), Basophil, Eosinophil, Lymphocyte, Monocyte and Neutrophil
High Neutrophil (n=58, 58)
|
0 participants
|
0 participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Platelet, White Blood Cell (WBC), Basophil, Eosinophil, Lymphocyte, Monocyte and Neutrophil
Low Neutrophil (n=58, 58)
|
20 participants
|
19 participants
|
SECONDARY outcome
Timeframe: Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)Population: The ITT population included all participants who received at least one injection
A marked abnormality was defined as a test result which was outside of the marked abnormality range, and which represented a clinically relevant change from baseline of at least the designated amount. The marked reference range for RBC was 3.80-6.10 (10\*12/L). The clinical relevant change (decrease/ increase) for RBC was (15%, 15%).
Outcome measures
| Measure |
Autoinjector
n=60 Participants
The AI group includes results from Weeks 1-3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1-3, followed by PFS for Weeks 4-6) and results from Weeks 4-6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1-3, followed by AI for Weeks 4-6)
|
Pre-filled Syringe
n=59 Participants
The PFS group includes results from Weeks 1-3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1-3, followed by AI for Weeks 4-6)and results from Weeks 4-6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1-3, followed by PFS for Weeks 4-6)
|
|---|---|---|
|
Number of Participants With Marked Laboratory Abnormalities in Right Blood Cell (RBC)
High Red Blood Cells (n=57, 57)
|
1 participants
|
0 participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Right Blood Cell (RBC)
Low Red Blood Cells (n=57, 57)
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)Population: The ITT population included all participants who received at least one injection
A marked abnormality was defined as a test result which was outside of the marked abnormality range, and which represented a clinically relevant change from baseline of at least the designated amount. The marked reference range for PT-INR was n.d.-2.00. The clinical relevant change (decrease/ increase) for PT-INR was (n.d, 30%).
Outcome measures
| Measure |
Autoinjector
n=60 Participants
The AI group includes results from Weeks 1-3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1-3, followed by PFS for Weeks 4-6) and results from Weeks 4-6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1-3, followed by AI for Weeks 4-6)
|
Pre-filled Syringe
n=59 Participants
The PFS group includes results from Weeks 1-3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1-3, followed by AI for Weeks 4-6)and results from Weeks 4-6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1-3, followed by PFS for Weeks 4-6)
|
|---|---|---|
|
Number of Participants With Marked Laboratory Abnormalities in Prothrombin Time (PT) International Normalized Ratio (INR)
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)Population: The ITT population included all participants who received at least one injection
A marked abnormality was defined as a test result which was outside of the marked abnormality range, and which represented a clinically relevant change from baseline of at least the designated amount. The marked reference range for SGOT was 0-80 (Units Per Litre \[U/L\]), SGPT was 0-110 U/L, and alkaline phosphatase was 0-220 U/L. The clinical relevant change (decrease/ increase) for SGOT was (n.d, 50%), SGPT was (n.d, 50%), and ALP was (n.d, 50%) respectively.
Outcome measures
| Measure |
Autoinjector
n=60 Participants
The AI group includes results from Weeks 1-3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1-3, followed by PFS for Weeks 4-6) and results from Weeks 4-6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1-3, followed by AI for Weeks 4-6)
|
Pre-filled Syringe
n=59 Participants
The PFS group includes results from Weeks 1-3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1-3, followed by AI for Weeks 4-6)and results from Weeks 4-6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1-3, followed by PFS for Weeks 4-6)
|
|---|---|---|
|
Number of Participants With Marked Laboratory Abnormalities in Serum Glutamic Oxaloacetic Transaminase (SGOT), Serum Glutamic-Pyruvic Transaminase (SGPT), and Alkaline Phosphatase
High SGOT (n=58, 58)
|
4 participants
|
4 participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Serum Glutamic Oxaloacetic Transaminase (SGOT), Serum Glutamic-Pyruvic Transaminase (SGPT), and Alkaline Phosphatase
High SGPT (n=58, 58)
|
2 participants
|
1 participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Serum Glutamic Oxaloacetic Transaminase (SGOT), Serum Glutamic-Pyruvic Transaminase (SGPT), and Alkaline Phosphatase
High Alkaline Phosphatase (n=58, 58)
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)Population: The ITT population included all participants who received at least one injection
A marked abnormality was defined as a test result which was outside of the marked abnormality range, and which represented a clinically relevant change from baseline of at least the designated amount. The marked reference range for BUN was 0.0-14.3 (millimoles per Liter \[mmol/L\]), Chloride was 95-115 (mmol/L), Potassium was 2.9-5.8 (mmol/L), Sodium was 130-150 (mmol/L), Calcium was 2.00-2.90 (mmol/L), and Glucose was 2.80-11.10 (mmol/L). The clinical relevant change (decrease/ increase) for BUN was (n.d, 50%), Chloride was (7%, 7%), Potassium was (20%, 20%), Sodium was (7%, 7%), Calcium was (10%, 10%), and Glucose was (75%, 75%) respectively.
Outcome measures
| Measure |
Autoinjector
n=60 Participants
The AI group includes results from Weeks 1-3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1-3, followed by PFS for Weeks 4-6) and results from Weeks 4-6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1-3, followed by AI for Weeks 4-6)
|
Pre-filled Syringe
n=59 Participants
The PFS group includes results from Weeks 1-3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1-3, followed by AI for Weeks 4-6)and results from Weeks 4-6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1-3, followed by PFS for Weeks 4-6)
|
|---|---|---|
|
Number of Participants With Marked Laboratory Abnormalities in Blood Urea Nitrogen (BUN), Chloride, Potassium, Sodium, Calcium, Glucose
High BUN (n=57, 57)
|
0 participants
|
0 participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Blood Urea Nitrogen (BUN), Chloride, Potassium, Sodium, Calcium, Glucose
High Chloride (n=58, 58)
|
0 participants
|
0 participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Blood Urea Nitrogen (BUN), Chloride, Potassium, Sodium, Calcium, Glucose
Low Chloride (n=58, 58)
|
0 participants
|
0 participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Blood Urea Nitrogen (BUN), Chloride, Potassium, Sodium, Calcium, Glucose
High Potassium (n=58, 58)
|
0 participants
|
0 participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Blood Urea Nitrogen (BUN), Chloride, Potassium, Sodium, Calcium, Glucose
Low Potassium (n=58, 58)
|
0 participants
|
0 participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Blood Urea Nitrogen (BUN), Chloride, Potassium, Sodium, Calcium, Glucose
High Sodium (n=58, 58)
|
0 participants
|
0 participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Blood Urea Nitrogen (BUN), Chloride, Potassium, Sodium, Calcium, Glucose
Low Sodium (n=58, 58)
|
0 participants
|
0 participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Blood Urea Nitrogen (BUN), Chloride, Potassium, Sodium, Calcium, Glucose
High Calcium (n=58, 58)
|
0 participants
|
0 participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Blood Urea Nitrogen (BUN), Chloride, Potassium, Sodium, Calcium, Glucose
Low Calcium (n=58, 58)
|
2 participants
|
2 participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Blood Urea Nitrogen (BUN), Chloride, Potassium, Sodium, Calcium, Glucose
High Glucose (n=58, 58)
|
0 participants
|
0 participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Blood Urea Nitrogen (BUN), Chloride, Potassium, Sodium, Calcium, Glucose
Low Glucose (n=58, 58)
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)Population: The ITT population included all participants who received at least one injection
A marked abnormality was defined as a test result which was outside of the marked abnormality range, and which represented a clinically relevant change from baseline of at least the designated amount. The marked reference range for Creatinine was 0- 154 (micromoles/liter \[umol/L\]). The clinical relevant change (decrease/ increase) for Creatinine was (n.d, 50%).
Outcome measures
| Measure |
Autoinjector
n=60 Participants
The AI group includes results from Weeks 1-3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1-3, followed by PFS for Weeks 4-6) and results from Weeks 4-6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1-3, followed by AI for Weeks 4-6)
|
Pre-filled Syringe
n=59 Participants
The PFS group includes results from Weeks 1-3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1-3, followed by AI for Weeks 4-6)and results from Weeks 4-6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1-3, followed by PFS for Weeks 4-6)
|
|---|---|---|
|
Number of Participants With Marked Laboratory Abnormalities in Creatinine
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Week 1, Day 1 (Baseline), Week 2 (Day 8 ± 2 days), Week 3 (Day 15 ± 2 days), Week 4 (Day 22 ± 2 days), Week 5 (Day 29 ± 2 days), Week 6 (Day 36 ± 2 days)Population: The ITT population included all participants who received at least one injection
The pulse rate, temperature and blood pressure was assessed during a physical examination. Pulse rate was assessed in beats per minute (bpm), temperature was assessed in degree Celsius (°С), and blood pressure was assessed in millimeters of mercury (mmHg). Vital signs were taken while the participant was supine.
Outcome measures
| Measure |
Autoinjector
n=60 Participants
The AI group includes results from Weeks 1-3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1-3, followed by PFS for Weeks 4-6) and results from Weeks 4-6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1-3, followed by AI for Weeks 4-6)
|
Pre-filled Syringe
n=59 Participants
The PFS group includes results from Weeks 1-3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1-3, followed by AI for Weeks 4-6)and results from Weeks 4-6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1-3, followed by PFS for Weeks 4-6)
|
|---|---|---|
|
Number of Participants With Abnormalities in Pulse Rate, Temperature, and Blood Pressure
High Pulse Rate
|
3 participants
|
4 participants
|
|
Number of Participants With Abnormalities in Pulse Rate, Temperature, and Blood Pressure
Low Pulse Rate
|
0 participants
|
0 participants
|
|
Number of Participants With Abnormalities in Pulse Rate, Temperature, and Blood Pressure
High Systolic Blood Pressure
|
7 participants
|
10 participants
|
|
Number of Participants With Abnormalities in Pulse Rate, Temperature, and Blood Pressure
Low Systolic Blood Pressure
|
0 participants
|
0 participants
|
|
Number of Participants With Abnormalities in Pulse Rate, Temperature, and Blood Pressure
High Diastolic Blood Pressure
|
9 participants
|
5 participants
|
|
Number of Participants With Abnormalities in Pulse Rate, Temperature, and Blood Pressure
Low Diastolic Blood Pressure
|
0 participants
|
0 participants
|
|
Number of Participants With Abnormalities in Pulse Rate, Temperature, and Blood Pressure
High Temperature
|
0 participants
|
0 participants
|
|
Number of Participants With Abnormalities in Pulse Rate, Temperature, and Blood Pressure
Low Temperature
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)Population: The ITT population included all participants who received at least one injection
A 12-lead ECG was recorded after the participant had been in a semi-supine position for at least 10 minutes. Any clinically significant abnormalities noted on an ECG after the first dose of study drug were captured as AEs
Outcome measures
| Measure |
Autoinjector
n=60 Participants
The AI group includes results from Weeks 1-3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1-3, followed by PFS for Weeks 4-6) and results from Weeks 4-6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1-3, followed by AI for Weeks 4-6)
|
Pre-filled Syringe
n=59 Participants
The PFS group includes results from Weeks 1-3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1-3, followed by AI for Weeks 4-6)and results from Weeks 4-6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1-3, followed by PFS for Weeks 4-6)
|
|---|---|---|
|
Number of Participants With Abnormalities in Electrocardiograms
|
2 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Upto Day 36Population: The ITT population included all participants who received at least one injection
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Outcome measures
| Measure |
Autoinjector
n=60 Participants
The AI group includes results from Weeks 1-3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1-3, followed by PFS for Weeks 4-6) and results from Weeks 4-6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1-3, followed by AI for Weeks 4-6)
|
Pre-filled Syringe
n=59 Participants
The PFS group includes results from Weeks 1-3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1-3, followed by AI for Weeks 4-6)and results from Weeks 4-6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1-3, followed by PFS for Weeks 4-6)
|
|---|---|---|
|
Number of Participants With Adverse Events (AE)
|
34 participants
|
38 participants
|
Adverse Events
Autoinjector
Serious events: 2 serious events
Other events: 21 other events
Deaths: 0 deaths
Pre-filled Syringe
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Autoinjector
n=60 participants at risk
The AI group includes results from Weeks 1-3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1-3, followed by PFS for Weeks 4-6) and results from Weeks 4-6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1-3, followed by AI for Weeks 4-6)
|
Pre-filled Syringe
n=59 participants at risk
The PFS group includes results from Weeks 1-3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1-3, followed by AI for Weeks 4-6)and results from Weeks 4-6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1-3, followed by PFS for Weeks 4-6)
|
|---|---|---|
|
General disorders
Chest Pain
|
1.7%
1/60 • Number of events 1 • Up to Week 6 (Day 36 ± 2 days)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/59 • Up to Week 6 (Day 36 ± 2 days)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Sarcoidosis
|
1.7%
1/60 • Number of events 1 • Up to Week 6 (Day 36 ± 2 days)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/59 • Up to Week 6 (Day 36 ± 2 days)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
Other adverse events
| Measure |
Autoinjector
n=60 participants at risk
The AI group includes results from Weeks 1-3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1-3, followed by PFS for Weeks 4-6) and results from Weeks 4-6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1-3, followed by AI for Weeks 4-6)
|
Pre-filled Syringe
n=59 participants at risk
The PFS group includes results from Weeks 1-3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1-3, followed by AI for Weeks 4-6)and results from Weeks 4-6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1-3, followed by PFS for Weeks 4-6)
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
13.3%
8/60 • Up to Week 6 (Day 36 ± 2 days)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
13.6%
8/59 • Up to Week 6 (Day 36 ± 2 days)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Gastrointestinal disorders
Diarrohea
|
6.7%
4/60 • Up to Week 6 (Day 36 ± 2 days)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
13.6%
8/59 • Up to Week 6 (Day 36 ± 2 days)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
3/60 • Up to Week 6 (Day 36 ± 2 days)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.1%
3/59 • Up to Week 6 (Day 36 ± 2 days)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.7%
4/60 • Up to Week 6 (Day 36 ± 2 days)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
1.7%
1/59 • Up to Week 6 (Day 36 ± 2 days)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.0%
3/60 • Up to Week 6 (Day 36 ± 2 days)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
1.7%
1/59 • Up to Week 6 (Day 36 ± 2 days)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
General disorders
Fatigue
|
13.3%
8/60 • Up to Week 6 (Day 36 ± 2 days)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
11.9%
7/59 • Up to Week 6 (Day 36 ± 2 days)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
General disorders
Pain
|
8.3%
5/60 • Up to Week 6 (Day 36 ± 2 days)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
8.5%
5/59 • Up to Week 6 (Day 36 ± 2 days)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
General disorders
Pyrexia
|
6.7%
4/60 • Up to Week 6 (Day 36 ± 2 days)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
8.5%
5/59 • Up to Week 6 (Day 36 ± 2 days)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
General disorders
Chills
|
5.0%
3/60 • Up to Week 6 (Day 36 ± 2 days)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
8.5%
5/59 • Up to Week 6 (Day 36 ± 2 days)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
General disorders
Irritability
|
5.0%
3/60 • Up to Week 6 (Day 36 ± 2 days)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
8.5%
5/59 • Up to Week 6 (Day 36 ± 2 days)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
General disorders
Early satiety
|
5.0%
3/60 • Up to Week 6 (Day 36 ± 2 days)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
1.7%
1/59 • Up to Week 6 (Day 36 ± 2 days)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
General disorders
Injection site erythema
|
5.0%
3/60 • Up to Week 6 (Day 36 ± 2 days)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
1.7%
1/59 • Up to Week 6 (Day 36 ± 2 days)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
6/60 • Up to Week 6 (Day 36 ± 2 days)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.1%
3/59 • Up to Week 6 (Day 36 ± 2 days)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/60 • Up to Week 6 (Day 36 ± 2 days)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.1%
3/59 • Up to Week 6 (Day 36 ± 2 days)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
8.3%
5/60 • Up to Week 6 (Day 36 ± 2 days)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
10.2%
6/59 • Up to Week 6 (Day 36 ± 2 days)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.7%
4/60 • Up to Week 6 (Day 36 ± 2 days)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
3.4%
2/59 • Up to Week 6 (Day 36 ± 2 days)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.7%
4/60 • Up to Week 6 (Day 36 ± 2 days)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
1.7%
1/59 • Up to Week 6 (Day 36 ± 2 days)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.7%
1/60 • Up to Week 6 (Day 36 ± 2 days)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.1%
3/59 • Up to Week 6 (Day 36 ± 2 days)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Nervous system disorders
Headache
|
6.7%
4/60 • Up to Week 6 (Day 36 ± 2 days)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
8.5%
5/59 • Up to Week 6 (Day 36 ± 2 days)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.3%
2/60 • Up to Week 6 (Day 36 ± 2 days)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.1%
3/59 • Up to Week 6 (Day 36 ± 2 days)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.0%
3/60 • Up to Week 6 (Day 36 ± 2 days)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
1.7%
1/59 • Up to Week 6 (Day 36 ± 2 days)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Psychiatric disorders
Insomnia
|
8.3%
5/60 • Up to Week 6 (Day 36 ± 2 days)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
3.4%
2/59 • Up to Week 6 (Day 36 ± 2 days)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
Additional Information
Roche Trial Information Hotline
F. Hoffmann-La Roche AG
Phone: +41 61 6878333
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER