Trial Outcomes & Findings for Extended Administration of Polyethylene Glycol (PEG) Interferon Alfa-2b in Participants With Solid Tumors (C/I97-349/MK-4031-009) (NCT NCT03554005)
NCT ID: NCT03554005
Last Updated: 2019-07-15
Results Overview
An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
29 participants
Primary outcome timeframe
Up to 42 Weeks
Results posted on
2019-07-15
Participant Flow
Participant milestones
| Measure |
PEG Interferon Alfa-2b 0.75 mcg/kg Once Weekly (OW)
Participants received PEG interferon alfa-2b 0.75 mcg/kg by subcutaneous (SC) injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
|
PEG Interferon Alfa-2b 1.5 mcg/kg OW
Participants received PEG interferon alfa-2b 1.5 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
|
PEG Interferon Alfa-2b 3 mcg/kg OW
Participants received PEG interferon alfa-2b 3 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
|
PEG Interferon Alfa-2b 4.5 mcg/kg OW
Participants received PEG interferon alfa-2b 4.5 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
|
PEG Interferon Alfa-2b 6 mcg/kg OW
Participants received PEG interferon alfa-2b 6 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
|
PEG Interferon Alfa-2b 7.5 mcg/kg OW
Participants received PEG interferon alfa-2b 7.5 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
2
|
2
|
2
|
11
|
11
|
|
Overall Study
COMPLETED
|
0
|
1
|
1
|
1
|
5
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
1
|
6
|
11
|
Reasons for withdrawal
| Measure |
PEG Interferon Alfa-2b 0.75 mcg/kg Once Weekly (OW)
Participants received PEG interferon alfa-2b 0.75 mcg/kg by subcutaneous (SC) injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
|
PEG Interferon Alfa-2b 1.5 mcg/kg OW
Participants received PEG interferon alfa-2b 1.5 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
|
PEG Interferon Alfa-2b 3 mcg/kg OW
Participants received PEG interferon alfa-2b 3 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
|
PEG Interferon Alfa-2b 4.5 mcg/kg OW
Participants received PEG interferon alfa-2b 4.5 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
|
PEG Interferon Alfa-2b 6 mcg/kg OW
Participants received PEG interferon alfa-2b 6 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
|
PEG Interferon Alfa-2b 7.5 mcg/kg OW
Participants received PEG interferon alfa-2b 7.5 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
|
|---|---|---|---|---|---|---|
|
Overall Study
Not in participant's best interest
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Disease Progression
|
1
|
1
|
1
|
1
|
5
|
6
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
3
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Other
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Extended Administration of Polyethylene Glycol (PEG) Interferon Alfa-2b in Participants With Solid Tumors (C/I97-349/MK-4031-009)
Baseline characteristics by cohort
| Measure |
PEG Interferon Alfa-2b 0.75 mcg/kg OW
n=1 Participants
Participants received PEG interferon alfa-2b 0.75 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
|
PEG Interferon Alfa-2b 1.5 mcg/kg OW
n=2 Participants
Participants received PEG interferon alfa-2b 1.5 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
|
PEG Interferon Alfa-2b 3 mcg/kg OW
n=2 Participants
Participants received PEG interferon alfa-2b 3 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
|
PEG Interferon Alfa-2b 4.5 mcg/kg OW
n=2 Participants
Participants received PEG interferon alfa-2b 4.5 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
|
PEG Interferon Alfa-2b 6 mcg/kg OW
n=11 Participants
Participants received PEG interferon alfa-2b 6 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
|
PEG Interferon Alfa-2b 7.5 mcg/kg OW
n=11 Participants
Participants received PEG interferon alfa-2b 7.5 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
62.0 Years
STANDARD_DEVIATION NA • n=113 Participants
|
51.5 Years
STANDARD_DEVIATION 14.8 • n=163 Participants
|
52 Years
STANDARD_DEVIATION 0.0 • n=160 Participants
|
59.5 Years
STANDARD_DEVIATION 10.6 • n=483 Participants
|
55.4 Years
STANDARD_DEVIATION 9.6 • n=36 Participants
|
55.8 Years
STANDARD_DEVIATION 10.7 • n=10 Participants
|
55.6 Years
STANDARD_DEVIATION 9.5 • n=115 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=113 Participants
|
1 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
1 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=113 Participants
|
1 Participants
n=163 Participants
|
2 Participants
n=160 Participants
|
1 Participants
n=483 Participants
|
8 Participants
n=36 Participants
|
10 Participants
n=10 Participants
|
22 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Up to 42 WeeksPopulation: All enrolled participants
An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
Outcome measures
| Measure |
PEG Interferon Alfa-2b 0.75 mcg/kg OW
n=1 Participants
Participants received PEG interferon alfa-2b 0.75 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
|
PEG Interferon Alfa-2b 1.5 mcg/kg OW
n=2 Participants
Participants received PEG interferon alfa-2b 1.5 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
|
PEG Interferon Alfa-2b 3 mcg/kg OW
n=2 Participants
Participants received PEG interferon alfa-2b 3 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
|
PEG Interferon Alfa-2b 4.5 mcg/kg OW
n=2 Participants
Participants received PEG interferon alfa-2b 4.5 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
|
PEG Interferon Alfa-2b 6 mcg/kg OW
n=11 Participants
Participants received PEG interferon alfa-2b 6 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
|
PEG Interferon Alfa-2b 7.5 mcg/kg OW
n=11 Participants
Participants received PEG interferon alfa-2b 7.5 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced an Adverse Event
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
11 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: Up to 40 WeeksPopulation: All enrolled participants
An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
Outcome measures
| Measure |
PEG Interferon Alfa-2b 0.75 mcg/kg OW
n=1 Participants
Participants received PEG interferon alfa-2b 0.75 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
|
PEG Interferon Alfa-2b 1.5 mcg/kg OW
n=2 Participants
Participants received PEG interferon alfa-2b 1.5 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
|
PEG Interferon Alfa-2b 3 mcg/kg OW
n=2 Participants
Participants received PEG interferon alfa-2b 3 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
|
PEG Interferon Alfa-2b 4.5 mcg/kg OW
n=2 Participants
Participants received PEG interferon alfa-2b 4.5 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
|
PEG Interferon Alfa-2b 6 mcg/kg OW
n=11 Participants
Participants received PEG interferon alfa-2b 6 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
|
PEG Interferon Alfa-2b 7.5 mcg/kg OW
n=11 Participants
Participants received PEG interferon alfa-2b 7.5 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Discontinued Treatment Due to an Adverse Event
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 40 WeeksPopulation: All enrolled participants
Best Objective Response data were based on World Health Organization (WHO) criteria and included four categories. Complete Response (CR) was the disappearance of all clinically detectable malignant disease. Partial Response (PR) was a decrease of ≥50% of the sum of products of largest perpendicular diameters of all bidimensionally measurable lesions; and a decrease of ≥50% in sum of largest diameters of all unidimensionally measure lesions. Stable Disease (SD) was a \<50% decrease or \<25% increase in sum of products of largest perpendicular diameters of all bidimensionally measurable lesions; or a \<50% decrease or \<25% increase in sum of diameters of all unidimensionally measurable lesions. In addition, no new lesions appeared. Progressive Disease (PD) was a ≥25% increase in size of at least one bidimensionally or unidimensionally measurable lesion or appearance of new lesion. Occurrence of pleural effusion or ascites was also considered PD if substantiated by positive cytology.
Outcome measures
| Measure |
PEG Interferon Alfa-2b 0.75 mcg/kg OW
n=1 Participants
Participants received PEG interferon alfa-2b 0.75 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
|
PEG Interferon Alfa-2b 1.5 mcg/kg OW
n=2 Participants
Participants received PEG interferon alfa-2b 1.5 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
|
PEG Interferon Alfa-2b 3 mcg/kg OW
n=2 Participants
Participants received PEG interferon alfa-2b 3 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
|
PEG Interferon Alfa-2b 4.5 mcg/kg OW
n=2 Participants
Participants received PEG interferon alfa-2b 4.5 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
|
PEG Interferon Alfa-2b 6 mcg/kg OW
n=11 Participants
Participants received PEG interferon alfa-2b 6 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
|
PEG Interferon Alfa-2b 7.5 mcg/kg OW
n=11 Participants
Participants received PEG interferon alfa-2b 7.5 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
|
|---|---|---|---|---|---|---|
|
Best Objective Response
Complete Response (CR)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Best Objective Response
Partial Response (PR)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
|
Best Objective Response
Stable Disease (SD)
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
6 Participants
|
4 Participants
|
|
Best Objective Response
Progressive Disease (PD)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Best Objective Response
Not Evaluated
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
Adverse Events
PEG Interferon Alfa-2b 0.75 mcg/kg OW
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
PEG Interferon Alfa-2b 1.5 mcg/kg OW
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
PEG Interferon Alfa-2b 3 mcg/kg OW
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
PEG Interferon Alfa-2b 4.5 mcg/kg OW
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
PEG Interferon Alfa-2b 6 mcg/kg OW
Serious events: 1 serious events
Other events: 11 other events
Deaths: 1 deaths
PEG Interferon Alfa-2b 7.5 mcg/kg OW
Serious events: 3 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PEG Interferon Alfa-2b 0.75 mcg/kg OW
n=1 participants at risk
Participants received PEG interferon alfa-2b 0.75 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
|
PEG Interferon Alfa-2b 1.5 mcg/kg OW
n=2 participants at risk
Participants received PEG interferon alfa-2b 1.5 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
|
PEG Interferon Alfa-2b 3 mcg/kg OW
n=2 participants at risk
Participants received PEG interferon alfa-2b 3 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
|
PEG Interferon Alfa-2b 4.5 mcg/kg OW
n=2 participants at risk
Participants received PEG interferon alfa-2b 4.5 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
|
PEG Interferon Alfa-2b 6 mcg/kg OW
n=11 participants at risk
Participants received PEG interferon alfa-2b 6 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
|
PEG Interferon Alfa-2b 7.5 mcg/kg OW
n=11 participants at risk
Participants received PEG interferon alfa-2b 7.5 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
|
General disorders
ASTHENIA
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
50.0%
1/2 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
|
General disorders
PAIN
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
50.0%
1/2 • Number of events 2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
|
General disorders
PYREXIA
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
|
Musculoskeletal and connective tissue disorders
JOINT SWELLING
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
|
Nervous system disorders
CONVULSION
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
50.0%
1/2 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
Other adverse events
| Measure |
PEG Interferon Alfa-2b 0.75 mcg/kg OW
n=1 participants at risk
Participants received PEG interferon alfa-2b 0.75 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
|
PEG Interferon Alfa-2b 1.5 mcg/kg OW
n=2 participants at risk
Participants received PEG interferon alfa-2b 1.5 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
|
PEG Interferon Alfa-2b 3 mcg/kg OW
n=2 participants at risk
Participants received PEG interferon alfa-2b 3 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
|
PEG Interferon Alfa-2b 4.5 mcg/kg OW
n=2 participants at risk
Participants received PEG interferon alfa-2b 4.5 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
|
PEG Interferon Alfa-2b 6 mcg/kg OW
n=11 participants at risk
Participants received PEG interferon alfa-2b 6 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
|
PEG Interferon Alfa-2b 7.5 mcg/kg OW
n=11 participants at risk
Participants received PEG interferon alfa-2b 7.5 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
|
Eye disorders
EYE IRRITATION
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
|
Eye disorders
VISUAL ACUITY REDUCED
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
50.0%
1/2 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
50.0%
1/2 • Number of events 4 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
18.2%
2/11 • Number of events 2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
100.0%
1/1 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
18.2%
2/11 • Number of events 2 • Up to 42 weeks
All enrolled participants
|
18.2%
2/11 • Number of events 4 • Up to 42 weeks
All enrolled participants
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
27.3%
3/11 • Number of events 3 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
|
Gastrointestinal disorders
ASCITES
|
100.0%
1/1 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
50.0%
1/2 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
27.3%
3/11 • Number of events 5 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 3 • Up to 42 weeks
All enrolled participants
|
|
Gastrointestinal disorders
DIARRHOEA
|
100.0%
1/1 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
50.0%
1/2 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
27.3%
3/11 • Number of events 4 • Up to 42 weeks
All enrolled participants
|
18.2%
2/11 • Number of events 2 • Up to 42 weeks
All enrolled participants
|
|
Gastrointestinal disorders
DRY MOUTH
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
27.3%
3/11 • Number of events 4 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
|
Gastrointestinal disorders
DYSPHAGIA
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
50.0%
1/2 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
|
Gastrointestinal disorders
FLATULENCE
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
50.0%
1/2 • Number of events 2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
|
Gastrointestinal disorders
GASTRITIS
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 2 • Up to 42 weeks
All enrolled participants
|
|
Gastrointestinal disorders
GINGIVAL BLEEDING
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
|
Gastrointestinal disorders
HAEMATOCHEZIA
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
100.0%
2/2 • Number of events 3 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
18.2%
2/11 • Number of events 2 • Up to 42 weeks
All enrolled participants
|
36.4%
4/11 • Number of events 5 • Up to 42 weeks
All enrolled participants
|
|
Gastrointestinal disorders
STOMACH DISCOMFORT
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
50.0%
1/2 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 3 • Up to 42 weeks
All enrolled participants
|
18.2%
2/11 • Number of events 2 • Up to 42 weeks
All enrolled participants
|
|
General disorders
ASTHENIA
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
50.0%
1/2 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
18.2%
2/11 • Number of events 2 • Up to 42 weeks
All enrolled participants
|
|
General disorders
CHEST DISCOMFORT
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
|
General disorders
CHEST PAIN
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
|
General disorders
CHILLS
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
100.0%
2/2 • Number of events 5 • Up to 42 weeks
All enrolled participants
|
50.0%
1/2 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
50.0%
1/2 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
|
General disorders
FATIGUE
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
100.0%
2/2 • Number of events 5 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
50.0%
1/2 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
54.5%
6/11 • Number of events 15 • Up to 42 weeks
All enrolled participants
|
27.3%
3/11 • Number of events 4 • Up to 42 weeks
All enrolled participants
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
50.0%
1/2 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 3 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
|
General disorders
INJECTION SITE ERYTHEMA
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
50.0%
1/2 • Number of events 2 • Up to 42 weeks
All enrolled participants
|
50.0%
1/2 • Number of events 2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
27.3%
3/11 • Number of events 4 • Up to 42 weeks
All enrolled participants
|
18.2%
2/11 • Number of events 3 • Up to 42 weeks
All enrolled participants
|
|
General disorders
INJECTION SITE PAIN
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
18.2%
2/11 • Number of events 2 • Up to 42 weeks
All enrolled participants
|
|
General disorders
INJECTION SITE PRURITUS
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
|
General disorders
INJECTION SITE REACTION
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
|
General disorders
INJECTION SITE WARMTH
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
|
General disorders
MALAISE
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
|
General disorders
OEDEMA PERIPHERAL
|
100.0%
1/1 • Number of events 2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
|
General disorders
PAIN
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
18.2%
2/11 • Number of events 2 • Up to 42 weeks
All enrolled participants
|
|
General disorders
PYREXIA
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
100.0%
2/2 • Number of events 3 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
50.0%
1/2 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
27.3%
3/11 • Number of events 4 • Up to 42 weeks
All enrolled participants
|
|
General disorders
RESPIRATORY SIGHS
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
|
Infections and infestations
ORAL CANDIDIASIS
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
|
Infections and infestations
OTITIS MEDIA
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
|
Infections and infestations
SINUSITIS
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 2 • Up to 42 weeks
All enrolled participants
|
|
Infections and infestations
STREPTOCOCCAL INFECTION
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
|
Infections and infestations
TOOTH ABSCESS
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
50.0%
1/2 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
|
Injury, poisoning and procedural complications
INCISION SITE PAIN
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
|
Injury, poisoning and procedural complications
THERMAL BURN
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
|
Investigations
WEIGHT DECREASED
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
50.0%
1/2 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
45.5%
5/11 • Number of events 5 • Up to 42 weeks
All enrolled participants
|
27.3%
3/11 • Number of events 3 • Up to 42 weeks
All enrolled participants
|
|
Metabolism and nutrition disorders
ANOREXIA
|
100.0%
1/1 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
50.0%
1/2 • Number of events 2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
18.2%
2/11 • Number of events 3 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
|
Metabolism and nutrition disorders
APPETITE DISORDER
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
27.3%
3/11 • Number of events 4 • Up to 42 weeks
All enrolled participants
|
27.3%
3/11 • Number of events 5 • Up to 42 weeks
All enrolled participants
|
|
Metabolism and nutrition disorders
INCREASED APPETITE
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
50.0%
1/2 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
50.0%
1/2 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
18.2%
2/11 • Number of events 3 • Up to 42 weeks
All enrolled participants
|
27.3%
3/11 • Number of events 9 • Up to 42 weeks
All enrolled participants
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
50.0%
1/2 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
27.3%
3/11 • Number of events 3 • Up to 42 weeks
All enrolled participants
|
18.2%
2/11 • Number of events 3 • Up to 42 weeks
All enrolled participants
|
|
Musculoskeletal and connective tissue disorders
LOWER EXTREMITY MASS
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
50.0%
1/2 • Number of events 2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
18.2%
2/11 • Number of events 4 • Up to 42 weeks
All enrolled participants
|
18.2%
2/11 • Number of events 2 • Up to 42 weeks
All enrolled participants
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
50.0%
1/2 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
50.0%
1/2 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
36.4%
4/11 • Number of events 8 • Up to 42 weeks
All enrolled participants
|
18.2%
2/11 • Number of events 2 • Up to 42 weeks
All enrolled participants
|
|
Musculoskeletal and connective tissue disorders
MYALGIA INTERCOSTAL
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
18.2%
2/11 • Number of events 2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
100.0%
1/1 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 2 • Up to 42 weeks
All enrolled participants
|
|
Musculoskeletal and connective tissue disorders
SENSATION OF HEAVINESS
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
50.0%
1/2 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
|
Nervous system disorders
APHASIA
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
|
Nervous system disorders
BURNING SENSATION
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
|
Nervous system disorders
DISTURBANCE IN ATTENTION
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
50.0%
1/2 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 2 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 3 • Up to 42 weeks
All enrolled participants
|
18.2%
2/11 • Number of events 3 • Up to 42 weeks
All enrolled participants
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
100.0%
2/2 • Number of events 4 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
50.0%
1/2 • Number of events 2 • Up to 42 weeks
All enrolled participants
|
27.3%
3/11 • Number of events 21 • Up to 42 weeks
All enrolled participants
|
36.4%
4/11 • Number of events 4 • Up to 42 weeks
All enrolled participants
|
|
Nervous system disorders
HYPOAESTHESIA
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
27.3%
3/11 • Number of events 3 • Up to 42 weeks
All enrolled participants
|
|
Nervous system disorders
LETHARGY
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 3 • Up to 42 weeks
All enrolled participants
|
|
Nervous system disorders
MEMORY IMPAIRMENT
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
50.0%
1/2 • Number of events 2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 2 • Up to 42 weeks
All enrolled participants
|
|
Nervous system disorders
MENTAL IMPAIRMENT
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
|
Nervous system disorders
MIGRAINE
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
18.2%
2/11 • Number of events 3 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
|
Nervous system disorders
NEURALGIA
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
|
Nervous system disorders
PARAESTHESIA
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
50.0%
1/2 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
|
Nervous system disorders
SCIATICA
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
|
Nervous system disorders
SENSORY DISTURBANCE
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
|
Nervous system disorders
TREMOR
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
|
Psychiatric disorders
APATHY
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
50.0%
1/2 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
|
Psychiatric disorders
DEPRESSION
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
50.0%
1/2 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
50.0%
1/2 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
|
Psychiatric disorders
FOOD AVERSION
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
|
Psychiatric disorders
INSOMNIA
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
50.0%
1/2 • Number of events 2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
18.2%
2/11 • Number of events 2 • Up to 42 weeks
All enrolled participants
|
|
Psychiatric disorders
LIBIDO DECREASED
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
|
Psychiatric disorders
SOCIAL PHOBIA
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
|
Renal and urinary disorders
DYSURIA
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 2 • Up to 42 weeks
All enrolled participants
|
|
Renal and urinary disorders
HAEMATURIA
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 2 • Up to 42 weeks
All enrolled participants
|
|
Reproductive system and breast disorders
GENITAL HAEMORRHAGE
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
50.0%
1/2 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
36.4%
4/11 • Number of events 5 • Up to 42 weeks
All enrolled participants
|
18.2%
2/11 • Number of events 4 • Up to 42 weeks
All enrolled participants
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
100.0%
1/1 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
50.0%
1/2 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
18.2%
2/11 • Number of events 2 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 2 • Up to 42 weeks
All enrolled participants
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
50.0%
1/2 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
|
Respiratory, thoracic and mediastinal disorders
INCREASED UPPER AIRWAY SECRETION
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
18.2%
2/11 • Number of events 3 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
50.0%
1/2 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
|
Skin and subcutaneous tissue disorders
ACNE
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
50.0%
1/2 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
50.0%
1/2 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
36.4%
4/11 • Number of events 8 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 2 • Up to 42 weeks
All enrolled participants
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
18.2%
2/11 • Number of events 2 • Up to 42 weeks
All enrolled participants
|
18.2%
2/11 • Number of events 2 • Up to 42 weeks
All enrolled participants
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 4 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
|
Skin and subcutaneous tissue disorders
EXFOLIATIVE RASH
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
|
Skin and subcutaneous tissue disorders
HAIR COLOUR CHANGES
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
50.0%
1/2 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
|
Skin and subcutaneous tissue disorders
PHOTOSENSITIVITY REACTION
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
100.0%
1/1 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
50.0%
1/2 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
27.3%
3/11 • Number of events 8 • Up to 42 weeks
All enrolled participants
|
|
Skin and subcutaneous tissue disorders
RASH MACULAR
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
18.2%
2/11 • Number of events 2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
|
Skin and subcutaneous tissue disorders
SCAR PAIN
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
|
Skin and subcutaneous tissue disorders
SKIN REACTION
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
|
Skin and subcutaneous tissue disorders
VITILIGO
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
50.0%
1/2 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
|
Vascular disorders
CIRCULATORY COLLAPSE
|
0.00%
0/1 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/2 • Up to 42 weeks
All enrolled participants
|
0.00%
0/11 • Up to 42 weeks
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up to 42 weeks
All enrolled participants
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator agrees to provide the Sponsor, thirty (30) days prior to submission for publication or presentation, copies of abstracts or manuscripts for publication which report project results. The Sponsor shall have editorial rights with respect to publications, abstracts, slides, and manuscripts, and the right to review and comment on the data analysis and presentation with regard to (a) proprietary information and, (b) the accuracy of the information contained in the publication.
- Publication restrictions are in place
Restriction type: OTHER