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Trial record 69 of 1274 for:    IFNA2

Extended Administration of Polyethylene Glycol (PEG) Interferon Alfa-2b in Participants With Solid Tumors (C/I97-349/MK-4031-009)

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ClinicalTrials.gov Identifier: NCT03554005
Recruitment Status : Completed
First Posted : June 12, 2018
Results First Posted : July 15, 2019
Last Update Posted : July 15, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Neoplasms
Interventions Drug: PEG Interferon Alfa-2b
Drug: Acetaminophen
Enrollment 29
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PEG Interferon Alfa-2b 0.75 mcg/kg Once Weekly (OW) PEG Interferon Alfa-2b 1.5 mcg/kg OW PEG Interferon Alfa-2b 3 mcg/kg OW PEG Interferon Alfa-2b 4.5 mcg/kg OW PEG Interferon Alfa-2b 6 mcg/kg OW PEG Interferon Alfa-2b 7.5 mcg/kg OW
Hide Arm/Group Description 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. 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. 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. 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. 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. 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.
Period Title: Overall Study
Started 1 2 2 2 11 11
Completed 0 1 1 1 5 0
Not Completed 1 1 1 1 6 11
Reason Not Completed
Not in participant's best interest             0             0             0             0             0             1
Disease Progression             1             1             1             1             5             6
Adverse Event             0             0             0             0             0             3
Physician Decision             0             0             0             0             1             0
Other             0             0             0             0             0             1
Arm/Group Title PEG Interferon Alfa-2b 0.75 mcg/kg OW PEG Interferon Alfa-2b 1.5 mcg/kg OW PEG Interferon Alfa-2b 3 mcg/kg OW PEG Interferon Alfa-2b 4.5 mcg/kg OW PEG Interferon Alfa-2b 6 mcg/kg OW PEG Interferon Alfa-2b 7.5 mcg/kg OW Total
Hide Arm/Group Description 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. 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. 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. 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. 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. 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 of all reporting groups
Overall Number of Baseline Participants 1 2 2 2 11 11 29
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1 participants 2 participants 2 participants 2 participants 11 participants 11 participants 29 participants
62.0 [1]   (NA) 51.5  (14.8) 52  (0.0) 59.5  (10.6) 55.4  (9.6) 55.8  (10.7) 55.6  (9.5)
[1]
The standard deviation cannot be calculated for 1 participant.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 2 participants 2 participants 2 participants 11 participants 11 participants 29 participants
Female
1
 100.0%
1
  50.0%
0
   0.0%
1
  50.0%
3
  27.3%
1
   9.1%
7
  24.1%
Male
0
   0.0%
1
  50.0%
2
 100.0%
1
  50.0%
8
  72.7%
10
  90.9%
22
  75.9%
1.Primary Outcome
Title Number of Participants Who Experienced an Adverse Event
Hide Description 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.
Time Frame Up to 42 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants
Arm/Group Title PEG Interferon Alfa-2b 0.75 mcg/kg OW PEG Interferon Alfa-2b 1.5 mcg/kg OW PEG Interferon Alfa-2b 3 mcg/kg OW PEG Interferon Alfa-2b 4.5 mcg/kg OW PEG Interferon Alfa-2b 6 mcg/kg OW PEG Interferon Alfa-2b 7.5 mcg/kg OW
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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 Number of Participants Analyzed 1 2 2 2 11 11
Measure Type: Count of Participants
Unit of Measure: Participants
1
 100.0%
2
 100.0%
1
  50.0%
2
 100.0%
11
 100.0%
11
 100.0%
2.Primary Outcome
Title Number of Participants Who Discontinued Treatment Due to an Adverse Event
Hide Description 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.
Time Frame Up to 40 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants
Arm/Group Title PEG Interferon Alfa-2b 0.75 mcg/kg OW PEG Interferon Alfa-2b 1.5 mcg/kg OW PEG Interferon Alfa-2b 3 mcg/kg OW PEG Interferon Alfa-2b 4.5 mcg/kg OW PEG Interferon Alfa-2b 6 mcg/kg OW PEG Interferon Alfa-2b 7.5 mcg/kg OW
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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 Number of Participants Analyzed 1 2 2 2 11 11
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
3
  27.3%
3.Secondary Outcome
Title Best Objective Response
Hide Description 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.
Time Frame Up to 40 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants
Arm/Group Title PEG Interferon Alfa-2b 0.75 mcg/kg OW PEG Interferon Alfa-2b 1.5 mcg/kg OW PEG Interferon Alfa-2b 3 mcg/kg OW PEG Interferon Alfa-2b 4.5 mcg/kg OW PEG Interferon Alfa-2b 6 mcg/kg OW PEG Interferon Alfa-2b 7.5 mcg/kg OW
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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 Number of Participants Analyzed 1 2 2 2 11 11
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response (CR)
0
   0.0%
0
   0.0%
1
  50.0%
0
   0.0%
3
  27.3%
0
   0.0%
Partial Response (PR)
0
   0.0%
0
   0.0%
0
   0.0%
1
  50.0%
0
   0.0%
4
  36.4%
Stable Disease (SD)
1
 100.0%
2
 100.0%
0
   0.0%
0
   0.0%
6
  54.5%
4
  36.4%
Progressive Disease (PD)
0
   0.0%
0
   0.0%
0
   0.0%
1
  50.0%
1
   9.1%
2
  18.2%
Not Evaluated
0
   0.0%
0
   0.0%
1
  50.0%
0
   0.0%
1
   9.1%
1
   9.1%
Time Frame Up to 42 weeks
Adverse Event Reporting Description All enrolled participants
 
Arm/Group Title PEG Interferon Alfa-2b 0.75 mcg/kg OW PEG Interferon Alfa-2b 1.5 mcg/kg OW PEG Interferon Alfa-2b 3 mcg/kg OW PEG Interferon Alfa-2b 4.5 mcg/kg OW PEG Interferon Alfa-2b 6 mcg/kg OW PEG Interferon Alfa-2b 7.5 mcg/kg OW
Hide Arm/Group Description 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. 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. 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. 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. 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. 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.
All-Cause Mortality
PEG Interferon Alfa-2b 0.75 mcg/kg OW PEG Interferon Alfa-2b 1.5 mcg/kg OW PEG Interferon Alfa-2b 3 mcg/kg OW PEG Interferon Alfa-2b 4.5 mcg/kg OW PEG Interferon Alfa-2b 6 mcg/kg OW PEG Interferon Alfa-2b 7.5 mcg/kg OW
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)      0/2 (0.00%)      0/2 (0.00%)      0/2 (0.00%)      1/11 (9.09%)      0/11 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
PEG Interferon Alfa-2b 0.75 mcg/kg OW PEG Interferon Alfa-2b 1.5 mcg/kg OW PEG Interferon Alfa-2b 3 mcg/kg OW PEG Interferon Alfa-2b 4.5 mcg/kg OW PEG Interferon Alfa-2b 6 mcg/kg OW PEG Interferon Alfa-2b 7.5 mcg/kg OW
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/1 (0.00%)      1/2 (50.00%)      0/2 (0.00%)      0/2 (0.00%)      1/11 (9.09%)      3/11 (27.27%)    
Cardiac disorders             
ACUTE MYOCARDIAL INFARCTION  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/11 (0.00%)  0 1/11 (9.09%)  1
General disorders             
ASTHENIA  1  0/1 (0.00%)  0 1/2 (50.00%)  1 0/2 (0.00%)  0 0/2 (0.00%)  0 0/11 (0.00%)  0 0/11 (0.00%)  0
PAIN  1  0/1 (0.00%)  0 1/2 (50.00%)  2 0/2 (0.00%)  0 0/2 (0.00%)  0 0/11 (0.00%)  0 0/11 (0.00%)  0
PYREXIA  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/11 (0.00%)  0 1/11 (9.09%)  1
Infections and infestations             
PNEUMONIA  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/11 (0.00%)  0 1/11 (9.09%)  1
Musculoskeletal and connective tissue disorders             
ARTHRALGIA  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/11 (0.00%)  0 1/11 (9.09%)  1
JOINT SWELLING  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/11 (0.00%)  0 1/11 (9.09%)  1
Nervous system disorders             
CONVULSION  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/11 (9.09%)  1 0/11 (0.00%)  0
SYNCOPE  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/11 (9.09%)  1 0/11 (0.00%)  0
Psychiatric disorders             
CONFUSIONAL STATE  1  0/1 (0.00%)  0 1/2 (50.00%)  1 0/2 (0.00%)  0 0/2 (0.00%)  0 0/11 (0.00%)  0 0/11 (0.00%)  0
1
Term from vocabulary, MedDRA 10.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PEG Interferon Alfa-2b 0.75 mcg/kg OW PEG Interferon Alfa-2b 1.5 mcg/kg OW PEG Interferon Alfa-2b 3 mcg/kg OW PEG Interferon Alfa-2b 4.5 mcg/kg OW PEG Interferon Alfa-2b 6 mcg/kg OW PEG Interferon Alfa-2b 7.5 mcg/kg OW
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/1 (100.00%)      2/2 (100.00%)      1/2 (50.00%)      2/2 (100.00%)      11/11 (100.00%)      11/11 (100.00%)    
Blood and lymphatic system disorders             
ANAEMIA  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/11 (0.00%)  0 1/11 (9.09%)  1
Eye disorders             
EYE IRRITATION  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/11 (9.09%)  1 0/11 (0.00%)  0
VISUAL ACUITY REDUCED  1  0/1 (0.00%)  0 1/2 (50.00%)  1 0/2 (0.00%)  0 0/2 (0.00%)  0 0/11 (0.00%)  0 0/11 (0.00%)  0
Gastrointestinal disorders             
ABDOMINAL DISTENSION  1  0/1 (0.00%)  0 1/2 (50.00%)  4 0/2 (0.00%)  0 0/2 (0.00%)  0 2/11 (18.18%)  2 0/11 (0.00%)  0
ABDOMINAL PAIN  1  1/1 (100.00%)  1 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 2/11 (18.18%)  2 2/11 (18.18%)  4
ABDOMINAL PAIN UPPER  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 3/11 (27.27%)  3 0/11 (0.00%)  0
ASCITES  1  1/1 (100.00%)  1 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/11 (0.00%)  0 0/11 (0.00%)  0
CONSTIPATION  1  0/1 (0.00%)  0 1/2 (50.00%)  1 0/2 (0.00%)  0 0/2 (0.00%)  0 3/11 (27.27%)  5 1/11 (9.09%)  3
DIARRHOEA  1  1/1 (100.00%)  1 1/2 (50.00%)  1 0/2 (0.00%)  0 0/2 (0.00%)  0 3/11 (27.27%)  4 2/11 (18.18%)  2
DRY MOUTH  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 3/11 (27.27%)  4 1/11 (9.09%)  1
DYSPHAGIA  1  0/1 (0.00%)  0 1/2 (50.00%)  1 0/2 (0.00%)  0 0/2 (0.00%)  0 0/11 (0.00%)  0 1/11 (9.09%)  1
FLATULENCE  1  0/1 (0.00%)  0 1/2 (50.00%)  2 0/2 (0.00%)  0 0/2 (0.00%)  0 0/11 (0.00%)  0 0/11 (0.00%)  0
GASTRITIS  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/11 (0.00%)  0 1/11 (9.09%)  2
GINGIVAL BLEEDING  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/11 (0.00%)  0 1/11 (9.09%)  1
HAEMATOCHEZIA  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/11 (0.00%)  0 1/11 (9.09%)  1
NAUSEA  1  0/1 (0.00%)  0 2/2 (100.00%)  3 0/2 (0.00%)  0 0/2 (0.00%)  0 2/11 (18.18%)  2 4/11 (36.36%)  5
STOMACH DISCOMFORT  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/11 (9.09%)  1 0/11 (0.00%)  0
VOMITING  1  0/1 (0.00%)  0 1/2 (50.00%)  1 0/2 (0.00%)  0 0/2 (0.00%)  0 1/11 (9.09%)  3 2/11 (18.18%)  2
General disorders             
ASTHENIA  1  0/1 (0.00%)  0 1/2 (50.00%)  1 0/2 (0.00%)  0 0/2 (0.00%)  0 1/11 (9.09%)  1 2/11 (18.18%)  2
CHEST DISCOMFORT  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/11 (9.09%)  1 0/11 (0.00%)  0
CHEST PAIN  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/11 (9.09%)  1 0/11 (0.00%)  0
CHILLS  1  0/1 (0.00%)  0 2/2 (100.00%)  5 1/2 (50.00%)  1 1/2 (50.00%)  1 1/11 (9.09%)  1 1/11 (9.09%)  1
FATIGUE  1  0/1 (0.00%)  0 2/2 (100.00%)  5 0/2 (0.00%)  0 1/2 (50.00%)  1 6/11 (54.55%)  15 3/11 (27.27%)  4
INFLUENZA LIKE ILLNESS  1  0/1 (0.00%)  0 0/2 (0.00%)  0 1/2 (50.00%)  1 0/2 (0.00%)  0 1/11 (9.09%)  3 0/11 (0.00%)  0
INJECTION SITE ERYTHEMA  1  0/1 (0.00%)  0 1/2 (50.00%)  2 1/2 (50.00%)  2 0/2 (0.00%)  0 3/11 (27.27%)  4 2/11 (18.18%)  3
INJECTION SITE PAIN  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/11 (9.09%)  1 2/11 (18.18%)  2
INJECTION SITE PRURITUS  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/11 (9.09%)  1 0/11 (0.00%)  0
INJECTION SITE REACTION  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/11 (9.09%)  1 0/11 (0.00%)  0
INJECTION SITE WARMTH  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/11 (0.00%)  0 1/11 (9.09%)  1
MALAISE  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/11 (9.09%)  1 0/11 (0.00%)  0
OEDEMA PERIPHERAL  1  1/1 (100.00%)  2 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/11 (0.00%)  0 1/11 (9.09%)  1
PAIN  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/11 (9.09%)  1 2/11 (18.18%)  2
PYREXIA  1  0/1 (0.00%)  0 2/2 (100.00%)  3 0/2 (0.00%)  0 1/2 (50.00%)  1 0/11 (0.00%)  0 3/11 (27.27%)  4
RESPIRATORY SIGHS  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/11 (0.00%)  0 1/11 (9.09%)  1
Infections and infestations             
LOWER RESPIRATORY TRACT INFECTION  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/11 (9.09%)  1 0/11 (0.00%)  0
ORAL CANDIDIASIS  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/11 (9.09%)  1 0/11 (0.00%)  0
OTITIS MEDIA  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/11 (0.00%)  0 1/11 (9.09%)  1
PNEUMONIA  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/11 (0.00%)  0 1/11 (9.09%)  1
SINUSITIS  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/11 (0.00%)  0 1/11 (9.09%)  2
STREPTOCOCCAL INFECTION  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/11 (9.09%)  1 0/11 (0.00%)  0
TOOTH ABSCESS  1  0/1 (0.00%)  0 1/2 (50.00%)  1 0/2 (0.00%)  0 0/2 (0.00%)  0 0/11 (0.00%)  0 0/11 (0.00%)  0
URINARY TRACT INFECTION  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/11 (9.09%)  1 0/11 (0.00%)  0
Injury, poisoning and procedural complications             
INCISION SITE PAIN  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/11 (9.09%)  1 0/11 (0.00%)  0
THERMAL BURN  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/11 (9.09%)  1 0/11 (0.00%)  0
Investigations             
WEIGHT DECREASED  1  0/1 (0.00%)  0 1/2 (50.00%)  1 0/2 (0.00%)  0 0/2 (0.00%)  0 5/11 (45.45%)  5 3/11 (27.27%)  3
Metabolism and nutrition disorders             
ANOREXIA  1  1/1 (100.00%)  1 1/2 (50.00%)  2 0/2 (0.00%)  0 0/2 (0.00%)  0 2/11 (18.18%)  3 0/11 (0.00%)  0
APPETITE DISORDER  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/11 (0.00%)  0 1/11 (9.09%)  1
DECREASED APPETITE  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 3/11 (27.27%)  4 3/11 (27.27%)  5
INCREASED APPETITE  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/2 (50.00%)  1 0/11 (0.00%)  0 0/11 (0.00%)  0
Musculoskeletal and connective tissue disorders             
ARTHRALGIA  1  0/1 (0.00%)  0 1/2 (50.00%)  1 0/2 (0.00%)  0 0/2 (0.00%)  0 2/11 (18.18%)  3 3/11 (27.27%)  9
BACK PAIN  1  0/1 (0.00%)  0 1/2 (50.00%)  1 0/2 (0.00%)  0 0/2 (0.00%)  0 3/11 (27.27%)  3 2/11 (18.18%)  3
LOWER EXTREMITY MASS  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/11 (9.09%)  1 0/11 (0.00%)  0
MUSCULAR WEAKNESS  1  0/1 (0.00%)  0 1/2 (50.00%)  2 0/2 (0.00%)  0 0/2 (0.00%)  0 2/11 (18.18%)  4 2/11 (18.18%)  2
MUSCULOSKELETAL CHEST PAIN  1  0/1 (0.00%)  0 1/2 (50.00%)  1 0/2 (0.00%)  0 1/2 (50.00%)  1 0/11 (0.00%)  0 1/11 (9.09%)  1
MYALGIA  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 4/11 (36.36%)  8 2/11 (18.18%)  2
MYALGIA INTERCOSTAL  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/11 (9.09%)  1 0/11 (0.00%)  0
NECK PAIN  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 2/11 (18.18%)  2 0/11 (0.00%)  0
PAIN IN EXTREMITY  1  1/1 (100.00%)  1 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/11 (0.00%)  0 1/11 (9.09%)  2
SENSATION OF HEAVINESS  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/2 (50.00%)  1 0/11 (0.00%)  0 0/11 (0.00%)  0
Nervous system disorders             
APHASIA  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/11 (0.00%)  0 1/11 (9.09%)  1
BURNING SENSATION  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/11 (9.09%)  1 0/11 (0.00%)  0
DISTURBANCE IN ATTENTION  1  0/1 (0.00%)  0 0/2 (0.00%)  0 1/2 (50.00%)  1 0/2 (0.00%)  0 1/11 (9.09%)  2 1/11 (9.09%)  1
DIZZINESS  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/11 (9.09%)  3 2/11 (18.18%)  3
HEADACHE  1  0/1 (0.00%)  0 2/2 (100.00%)  4 0/2 (0.00%)  0 1/2 (50.00%)  2 3/11 (27.27%)  21 4/11 (36.36%)  4
HYPOAESTHESIA  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/11 (0.00%)  0 3/11 (27.27%)  3
LETHARGY  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/11 (0.00%)  0 1/11 (9.09%)  3
MEMORY IMPAIRMENT  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/2 (50.00%)  2 0/11 (0.00%)  0 1/11 (9.09%)  2
MENTAL IMPAIRMENT  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/11 (0.00%)  0 1/11 (9.09%)  1
MIGRAINE  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 2/11 (18.18%)  3 0/11 (0.00%)  0
NEURALGIA  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/11 (0.00%)  0 1/11 (9.09%)  1
PARAESTHESIA  1  0/1 (0.00%)  0 1/2 (50.00%)  1 0/2 (0.00%)  0 0/2 (0.00%)  0 0/11 (0.00%)  0 1/11 (9.09%)  1
SCIATICA  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/11 (0.00%)  0 1/11 (9.09%)  1
SENSORY DISTURBANCE  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/11 (9.09%)  1 0/11 (0.00%)  0
SYNCOPE  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/11 (9.09%)  1 0/11 (0.00%)  0
TRANSIENT ISCHAEMIC ATTACK  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/11 (0.00%)  0 1/11 (9.09%)  1
TREMOR  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/11 (9.09%)  1 1/11 (9.09%)  1
Psychiatric disorders             
APATHY  1  0/1 (0.00%)  0 0/2 (0.00%)  0 1/2 (50.00%)  1 0/2 (0.00%)  0 0/11 (0.00%)  0 0/11 (0.00%)  0
DEPRESSION  1  0/1 (0.00%)  0 0/2 (0.00%)  0 1/2 (50.00%)  1 1/2 (50.00%)  1 1/11 (9.09%)  1 1/11 (9.09%)  1
FOOD AVERSION  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/11 (9.09%)  1 0/11 (0.00%)  0
INSOMNIA  1  0/1 (0.00%)  0 1/2 (50.00%)  2 0/2 (0.00%)  0 0/2 (0.00%)  0 0/11 (0.00%)  0 2/11 (18.18%)  2
LIBIDO DECREASED  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/11 (9.09%)  1 0/11 (0.00%)  0
SOCIAL PHOBIA  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/11 (9.09%)  2 0/11 (0.00%)  0
Renal and urinary disorders             
DYSURIA  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/11 (0.00%)  0 1/11 (9.09%)  2
HAEMATURIA  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/11 (9.09%)  1 1/11 (9.09%)  2
Reproductive system and breast disorders             
GENITAL HAEMORRHAGE  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/11 (9.09%)  1 0/11 (0.00%)  0
Respiratory, thoracic and mediastinal disorders             
COUGH  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/2 (50.00%)  1 4/11 (36.36%)  5 2/11 (18.18%)  4
DYSPNOEA  1  1/1 (100.00%)  1 1/2 (50.00%)  1 0/2 (0.00%)  0 0/2 (0.00%)  0 2/11 (18.18%)  2 1/11 (9.09%)  2
DYSPNOEA EXERTIONAL  1  0/1 (0.00%)  0 1/2 (50.00%)  1 0/2 (0.00%)  0 0/2 (0.00%)  0 0/11 (0.00%)  0 1/11 (9.09%)  1
HAEMOPTYSIS  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/11 (9.09%)  1 0/11 (0.00%)  0
INCREASED UPPER AIRWAY SECRETION  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/11 (0.00%)  0 1/11 (9.09%)  1
NASAL CONGESTION  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/11 (0.00%)  0 1/11 (9.09%)  1
OROPHARYNGEAL PAIN  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 2/11 (18.18%)  3 0/11 (0.00%)  0
PRODUCTIVE COUGH  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/11 (0.00%)  0 1/11 (9.09%)  1
RHINORRHOEA  1  0/1 (0.00%)  0 1/2 (50.00%)  1 0/2 (0.00%)  0 0/2 (0.00%)  0 1/11 (9.09%)  1 0/11 (0.00%)  0
Skin and subcutaneous tissue disorders             
ACNE  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/2 (50.00%)  1 0/11 (0.00%)  0 0/11 (0.00%)  0
ALOPECIA  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/2 (50.00%)  1 4/11 (36.36%)  8 1/11 (9.09%)  2
DRY SKIN  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 2/11 (18.18%)  2 2/11 (18.18%)  2
ERYTHEMA  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/11 (9.09%)  4 0/11 (0.00%)  0
EXFOLIATIVE RASH  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/11 (0.00%)  0 1/11 (9.09%)  1
HAIR COLOUR CHANGES  1  0/1 (0.00%)  0 0/2 (0.00%)  0 1/2 (50.00%)  1 0/2 (0.00%)  0 0/11 (0.00%)  0 0/11 (0.00%)  0
PHOTOSENSITIVITY REACTION  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/11 (0.00%)  0 1/11 (9.09%)  1
PRURITUS  1  1/1 (100.00%)  1 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/11 (9.09%)  1 1/11 (9.09%)  1
RASH  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/2 (50.00%)  1 1/11 (9.09%)  1 3/11 (27.27%)  8
RASH MACULAR  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 2/11 (18.18%)  2 0/11 (0.00%)  0
SCAR PAIN  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/11 (0.00%)  0 1/11 (9.09%)  1
SKIN REACTION  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 1/11 (9.09%)  1 0/11 (0.00%)  0
VITILIGO  1  0/1 (0.00%)  0 0/2 (0.00%)  0 1/2 (50.00%)  1 0/2 (0.00%)  0 0/11 (0.00%)  0 0/11 (0.00%)  0
Vascular disorders             
CIRCULATORY COLLAPSE  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0 0/11 (0.00%)  0 1/11 (9.09%)  1
1
Term from vocabulary, MedDRA 10.0
Indicates events were collected by systematic assessment
Adverse Event (AE) Preferred Terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT03554005     History of Changes
Other Study ID Numbers: C97349
MK-4031-009 ( Other Identifier: Merck Protocol Number )
C/l97-349 ( Other Identifier: Schering-Plough Protocol Number )
First Submitted: May 31, 2018
First Posted: June 12, 2018
Results First Submitted: March 26, 2019
Results First Posted: July 15, 2019
Last Update Posted: July 15, 2019