Trial Outcomes & Findings for Peginterferon α-2b as a Maintenance Therapy in Participants With Multiple Myeloma Who Responded to Induction Therapy (P01972-AM7) (NCT NCT00732641)
NCT ID: NCT00732641
Last Updated: 2017-04-04
Results Overview
PFS was defined as response duration while on maintenance therapy. It was the length of time during and after treatment in which a participant was living with the cancer that did not get worse. PFS was calculated from the date of randomization to the date of the first documented tumor progression or relapse.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
244 participants
Primary outcome timeframe
Baseline and up to 5 years (or to the date of the first documented tumor progression or relapse)
Results posted on
2017-04-04
Participant Flow
Participant milestones
| Measure |
Peginterferon α-2b
Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
|
No Treatment
Participants were observed and received no treatment
|
|---|---|---|
|
Overall Study
STARTED
|
123
|
121
|
|
Overall Study
COMPLETED
|
17
|
9
|
|
Overall Study
NOT COMPLETED
|
106
|
112
|
Reasons for withdrawal
| Measure |
Peginterferon α-2b
Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
|
No Treatment
Participants were observed and received no treatment
|
|---|---|---|
|
Overall Study
Relapse or Progressive Disease
|
65
|
101
|
|
Overall Study
Serious Adverse Events
|
12
|
3
|
|
Overall Study
Physician Decision
|
6
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
|
Overall Study
Unable to Complete
|
1
|
1
|
|
Overall Study
Other
|
18
|
5
|
Baseline Characteristics
Peginterferon α-2b as a Maintenance Therapy in Participants With Multiple Myeloma Who Responded to Induction Therapy (P01972-AM7)
Baseline characteristics by cohort
| Measure |
Peginterferon α-2b
n=122 Participants
Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
|
No Treatment
n=121 Participants
Participants were observed and received no treatment
|
Total
n=243 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.0 years
STANDARD_DEVIATION 8.5 • n=39 Participants
|
62.3 years
STANDARD_DEVIATION 8.6 • n=41 Participants
|
61.7 years
STANDARD_DEVIATION 8.6 • n=35 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=39 Participants
|
60 Participants
n=41 Participants
|
113 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
69 Participants
n=39 Participants
|
61 Participants
n=41 Participants
|
130 Participants
n=35 Participants
|
|
Region of Enrollment
Italy
|
123 participants
n=39 Participants
|
121 participants
n=41 Participants
|
244 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Baseline and up to 5 years (or to the date of the first documented tumor progression or relapse)Population: Intent-to-treat population (those who received at least one dose of study drug)
PFS was defined as response duration while on maintenance therapy. It was the length of time during and after treatment in which a participant was living with the cancer that did not get worse. PFS was calculated from the date of randomization to the date of the first documented tumor progression or relapse.
Outcome measures
| Measure |
Peginterferon α-2b
n=122 Participants
Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
|
No Treatment
n=121 Participants
Participants were observed and received no treatment
|
|---|---|---|
|
Number of Days With Progression Free Survival (PFS)
|
1166 Days
Interval 682.0 to 1519.0
|
519 Days
Interval 403.0 to 634.0
|
SECONDARY outcome
Timeframe: Baseline and up to 5 years (or to the date of the first documented tumor progression or relapse)Population: Intent-to-treat population (those who received at least one dose of study drug)
OS was calculated from the date of randomization to the date of death for any cause. Participants alive at the end of study were censored at the last date they were known to be alive. Participants who were still living at the end of the study were censored on the last date they were known to be alive.
Outcome measures
| Measure |
Peginterferon α-2b
n=122 Participants
Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
|
No Treatment
n=121 Participants
Participants were observed and received no treatment
|
|---|---|---|
|
Number of Days of Overall Survival (OS)
|
2333 Days
Interval 2255.0 to
not available - some participants were still living at the end of the study
|
2329 Days
Interval 1539.0 to
not available - some participants were still living at the end of the study
|
SECONDARY outcome
Timeframe: Month 9 & Month 18Population: Intent-to-treat population (those who received at least one dose of study drug)
CR was defined as: * Absence of the original monoclonal paraprotein in serum and urine by immunofixation, maintained for a minimum of 6 weeks; * \<5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy, if biopsy was performed. * No increase in size or number of lytic bone lesions (development of a compression fracture did not include response); * Disappearance of soft tissue plasmocytomas.
Outcome measures
| Measure |
Peginterferon α-2b
n=122 Participants
Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
|
No Treatment
n=121 Participants
Participants were observed and received no treatment
|
|---|---|---|
|
Number of Participants With Complete Response (CR) to Treatment
Month 9
|
16 Participants
|
16 Participants
|
|
Number of Participants With Complete Response (CR) to Treatment
Month 18
|
13 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Month 9 & Month 18Population: Intent-to-treat population (those who received at least one dose of study drug)
PR was defined as: * At least 50% reduction in the level of the serum monoclonal paraprotein, maintained for a minimum of 6 weeks; * Reduction in 24-hour urinary light chain excretion either by ≥ 90% or to \< 200 mg, maintained for a minimum of 6 weeks; * For patients with non-secretory myeloma only, ≥ 50% reduction in plasma cells in a bone marrow aspirate and on a trephine biopsy, if biopsy was performed, maintained for a minimum of 6 weeks; * At least 50% reduction in the size of soft tissue plasmacytomas; * No increase in size or number of lytic bone lesions.
Outcome measures
| Measure |
Peginterferon α-2b
n=122 Participants
Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
|
No Treatment
n=121 Participants
Participants were observed and received no treatment
|
|---|---|---|
|
Number of Participants With Partial Response (PR) to Treatment
Month 9
|
65 Participants
|
54 Participants
|
|
Number of Participants With Partial Response (PR) to Treatment
Month 18
|
45 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: Month 9 & Month 18Population: Intent-to-treat population (those who received at least one dose of study drug)
MR was defined as: * A 25-49% reduction in the level of the serum monoclonal paraprotein maintained for a minimum of 6 weeks; * Reduction in the 24-hour urinary light chain excretion, which still exceeded 200mg/24 hours, maintained for a minimum of 6 weeks; * For patients with non-secretory myeloma only, 25-49% reduction in plasma cells in a bone marrow aspirate and on a trephine biopsy, if biopsy was performed, maintained for a minimum of 6 weeks; * A 25-49% reduction in the size of soft tissue plasmacytomas; * No increase in the size or number of lityc lesions.
Outcome measures
| Measure |
Peginterferon α-2b
n=122 Participants
Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
|
No Treatment
n=121 Participants
Participants were observed and received no treatment
|
|---|---|---|
|
Number of Participants With Minimal Response (MR) to Treatment
Month 9
|
5 Participants
|
4 Participants
|
|
Number of Participants With Minimal Response (MR) to Treatment
Month 18
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Month 9 & Month 18Population: Intent-to-treat population (those who received at least one dose of study drug)
PD (for patients not in CR) required one or more of the following: * 25% increase in serum monoclonal paraprotein level, 24-hour urinary light chain excretion, or plasma cells; * Increase in size of existing or development of new bone lesions/soft tissue plasmacytomas; * Development of hypercalcemia. Relapse from CR required at least one of the following: * Reappearance of serum or urinary paraprotein; * \>5% plasma cells; * Development of new lytic bone lesions or soft tissue plasmacytomas or increase in the size of residual bone lesions; * Development of hypercalcemia.
Outcome measures
| Measure |
Peginterferon α-2b
n=122 Participants
Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
|
No Treatment
n=121 Participants
Participants were observed and received no treatment
|
|---|---|---|
|
Number of Participants With Progressive Disease(PD) or Relapse From CR
Month 9
|
36 Participants
|
47 Participants
|
|
Number of Participants With Progressive Disease(PD) or Relapse From CR
Month 18
|
63 Participants
|
77 Participants
|
SECONDARY outcome
Timeframe: Screening and Last Observation (up to 5 years)Population: Intent-to-treat population (those who received at least one dose of study drug). The number of participants analyzed varied depending on the number of observations available for each category.
Participants were given the Europen Organization for Research in Cancer Therapy Quality of Life Questionnaire (EORTC QLQ), version 2.0, which consisted of 30 questions. The questionnaire evaluated global health/quality of life and incorporated five functional scales (Physical; Role; Emotional; Cognitive; Social). All of the scales ranged in score from 0 (worst) to 100 (best).
Outcome measures
| Measure |
Peginterferon α-2b
n=122 Participants
Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
|
No Treatment
n=121 Participants
Participants were observed and received no treatment
|
|---|---|---|
|
Quality of Life
Physical Functioning Score (baseline)
|
80.3 Score on a scale
Standard Deviation 22.9
|
74.0 Score on a scale
Standard Deviation 25.6
|
|
Quality of Life
Physical Functioning Score (last observation)
|
68.9 Score on a scale
Standard Deviation 29.0
|
68.7 Score on a scale
Standard Deviation 27.4
|
|
Quality of Life
Physical Functioning Score (change)
|
-11.4 Score on a scale
Standard Deviation 28.5
|
-6.9 Score on a scale
Standard Deviation 29.2
|
|
Quality of Life
Role Functioning Score (baseline)
|
85.4 Score on a scale
Standard Deviation 18.8
|
77.6 Score on a scale
Standard Deviation 25.0
|
|
Quality of Life
Role Functioning Score (last observation)
|
71.0 Score on a scale
Standard Deviation 30.1
|
72.2 Score on a scale
Standard Deviation 27.1
|
|
Quality of Life
Role Functioning Score (change)
|
-14.1 Score on a scale
Standard Deviation 28.2
|
-8.0 Score on a scale
Standard Deviation 31.0
|
|
Quality of Life
Emotional Functioning Score (baseline)
|
83.7 Score on a scale
Standard Deviation 15.9
|
80.9 Score on a scale
Standard Deviation 19.5
|
|
Quality of Life
Emotional Functioning Score (last observation)
|
72.6 Score on a scale
Standard Deviation 23.7
|
74.6 Score on a scale
Standard Deviation 20.7
|
|
Quality of Life
Emotional Functioning Score (change)
|
-10.6 Score on a scale
Standard Deviation 19.1
|
-8.0 Score on a scale
Standard Deviation 22.2
|
|
Quality of Life
Cognitive Functioning Score (baseline)
|
90.3 Score on a scale
Standard Deviation 14.9
|
89.3 Score on a scale
Standard Deviation 16.4
|
|
Quality of Life
Cognitive Functioning Score (last observation)
|
82.9 Score on a scale
Standard Deviation 20.9
|
84.2 Score on a scale
Standard Deviation 19.3
|
|
Quality of Life
Cognitive Functioning Score (change)
|
-7.2 Score on a scale
Standard Deviation 17.8
|
-7.5 Score on a scale
Standard Deviation 16.9
|
|
Quality of Life
Social Functioning Score (baseline)
|
86.0 Score on a scale
Standard Deviation 20.2
|
82.3 Score on a scale
Standard Deviation 24.0
|
|
Quality of Life
Social Functioning Score (last observation)
|
79.7 Score on a scale
Standard Deviation 25.9
|
82.6 Score on a scale
Standard Deviation 24.4
|
|
Quality of Life
Social Functioning Score (change)
|
-6.4 Score on a scale
Standard Deviation 30.2
|
-1.9 Score on a scale
Standard Deviation 27.6
|
|
Quality of Life
Global Score (baseline)
|
44.0 Score on a scale
Standard Deviation 12.5
|
45.2 Score on a scale
Standard Deviation 10.8
|
|
Quality of Life
Global Score (last observation)
|
41.4 Score on a scale
Standard Deviation 12.5
|
42.0 Score on a scale
Standard Deviation 10.6
|
|
Quality of Life
Global Score (change)
|
-2.8 Score on a scale
Standard Deviation 15.5
|
-2.6 Score on a scale
Standard Deviation 13.1
|
Adverse Events
Peginterferon α-2b
Serious events: 27 serious events
Other events: 94 other events
Deaths: 0 deaths
No Treatment
Serious events: 21 serious events
Other events: 63 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Peginterferon α-2b
n=123 participants at risk
Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
|
No Treatment
n=121 participants at risk
Participants were observed and received no treatment
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.81%
1/123 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.83%
1/121 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.81%
1/123 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.00%
0/121
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.81%
1/123 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.00%
0/121
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.81%
1/123 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.00%
0/121
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.81%
1/123 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.83%
1/121 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.81%
1/123 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.00%
0/121
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Endocrine disorders
PRIMARY HYPOTHYROIDISM
|
0.81%
1/123 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.00%
0/121
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Eye disorders
CATARACT
|
0.81%
1/123 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.00%
0/121
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Eye disorders
EYE PAIN
|
0.81%
1/123 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.00%
0/121
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Eye disorders
RETINAL DETACHMENT
|
0.00%
0/123
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.83%
1/121 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Eye disorders
RETINAL VEIN THROMBOSIS
|
0.81%
1/123 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.00%
0/121
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Eye disorders
VISUAL ACUITY REDUCED
|
0.00%
0/123
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.83%
1/121 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Eye disorders
VISUAL IMPAIRMENT
|
0.81%
1/123 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.00%
0/121
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.81%
1/123 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.00%
0/121
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.81%
1/123 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.00%
0/121
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Gastrointestinal disorders
NAUSEA
|
0.81%
1/123 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.00%
0/121
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Gastrointestinal disorders
VOMITING
|
1.6%
2/123 • Number of events 2
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.00%
0/121
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
General disorders
CYST
|
1.6%
2/123 • Number of events 2
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.00%
0/121
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
General disorders
DISEASE PROGRESSION
|
3.3%
4/123 • Number of events 4
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
4.1%
5/121 • Number of events 5
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
General disorders
DISEASE RECURRENCE
|
0.00%
0/123
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.83%
1/121 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
General disorders
INJECTION SITE NECROSIS
|
0.81%
1/123 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.00%
0/121
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
General disorders
PYREXIA
|
1.6%
2/123 • Number of events 2
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.83%
1/121 • Number of events 2
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
General disorders
SUDDEN CARDIAC DEATH
|
0.00%
0/123
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.83%
1/121 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
General disorders
SWELLING
|
0.00%
0/123
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.83%
1/121 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Hepatobiliary disorders
HEPATITIS
|
0.00%
0/123
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.83%
1/121 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Hepatobiliary disorders
LIVER DISORDER
|
0.00%
0/123
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.83%
1/121 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Infections and infestations
BRONCHOPNEUMONIA
|
1.6%
2/123 • Number of events 2
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.83%
1/121 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Infections and infestations
DEVICE RELATED INFECTION
|
0.00%
0/123
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.83%
1/121 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Infections and infestations
ESCHERICHIA URINARY TRACT INFECTION
|
0.00%
0/123
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.83%
1/121 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Infections and infestations
HEPATITIS B
|
0.81%
1/123 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.83%
1/121 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Infections and infestations
HEPATITIS INFECTIOUS
|
0.81%
1/123 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.00%
0/121
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Infections and infestations
MENINGITIS
|
0.00%
0/123
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.83%
1/121 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Infections and infestations
PNEUMONIA
|
0.81%
1/123 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.00%
0/121
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Infections and infestations
PNEUMONIA BACTERIAL
|
0.00%
0/123
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.83%
1/121 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Infections and infestations
PNEUMONIA PNEUMOCOCCAL
|
0.00%
0/123
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.83%
1/121 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Infections and infestations
PSEUDOMONAL SEPSIS
|
0.81%
1/123 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.00%
0/121
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Infections and infestations
STAPHYLOCOCCAL SEPSIS
|
0.81%
1/123 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.00%
0/121
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
0.00%
0/123
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.83%
1/121 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Injury, poisoning and procedural complications
SUBDURAL HAEMATOMA
|
0.00%
0/123
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.83%
1/121 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
0.81%
1/123 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.00%
0/121
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Investigations
BLOOD LACTATE DEHYDROGENASE INCREASED
|
0.81%
1/123 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.00%
0/121
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Investigations
INTRAOCULAR PRESSURE INCREASED
|
0.81%
1/123 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.00%
0/121
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Metabolism and nutrition disorders
CACHEXIA
|
1.6%
2/123 • Number of events 2
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.00%
0/121
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Metabolism and nutrition disorders
HYPERCALCAEMIA
|
0.00%
0/123
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.83%
1/121 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Musculoskeletal and connective tissue disorders
OSTEONECROSIS OF JAW
|
0.81%
1/123 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.00%
0/121
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
0.00%
0/123
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.83%
1/121 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLON CANCER
|
0.00%
0/123
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.83%
1/121 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
GASTRIC CANCER
|
1.6%
2/123 • Number of events 2
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.00%
0/121
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
GLIOBLASTOMA
|
0.81%
1/123 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.00%
0/121
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MENINGIOMA
|
0.00%
0/123
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.83%
1/121 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO BONE
|
0.81%
1/123 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.00%
0/121
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PANCREATIC CARCINOMA
|
0.00%
0/123
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.83%
1/121 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER
|
0.81%
1/123 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.00%
0/121
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Nervous system disorders
CARPAL TUNNEL SYNDROME
|
0.81%
1/123 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.00%
0/121
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.00%
0/123
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.83%
1/121 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/123
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.83%
1/121 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
0.00%
0/123
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.83%
1/121 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Nervous system disorders
PARKINSON'S DISEASE
|
0.81%
1/123 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.00%
0/121
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.00%
0/123
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.83%
1/121 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Nervous system disorders
TREMOR
|
0.81%
1/123 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.00%
0/121
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.81%
1/123 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.00%
0/121
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
0.00%
0/123
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.83%
1/121 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
0.00%
0/123
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.83%
1/121 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Respiratory, thoracic and mediastinal disorders
INTERSTITIAL LUNG DISEASE
|
0.00%
0/123
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.83%
1/121 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.81%
1/123 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.00%
0/121
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY ARREST
|
0.81%
1/123 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.00%
0/121
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY DISORDER
|
0.00%
0/123
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.83%
1/121 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Surgical and medical procedures
THERAPEUTIC PROCEDURE
|
0.81%
1/123 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.00%
0/121
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.81%
1/123 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.00%
0/121
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Vascular disorders
HYPERTENSION
|
0.81%
1/123 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.00%
0/121
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Vascular disorders
JUGULAR VEIN THROMBOSIS
|
0.00%
0/123
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.83%
1/121 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
Other adverse events
| Measure |
Peginterferon α-2b
n=123 participants at risk
Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
|
No Treatment
n=121 participants at risk
Participants were observed and received no treatment
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
10.6%
13/123 • Number of events 13
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
12.4%
15/121 • Number of events 17
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
7.3%
9/123 • Number of events 10
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
2.5%
3/121 • Number of events 3
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
8.1%
10/123 • Number of events 12
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.83%
1/121 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
12.2%
15/123 • Number of events 20
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
2.5%
3/121 • Number of events 3
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Gastrointestinal disorders
DIARRHOEA
|
12.2%
15/123 • Number of events 20
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
2.5%
3/121 • Number of events 3
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
General disorders
ASTHENIA
|
15.4%
19/123 • Number of events 26
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
2.5%
3/121 • Number of events 3
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
General disorders
FATIGUE
|
6.5%
8/123 • Number of events 11
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.83%
1/121 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
17.1%
21/123 • Number of events 36
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
7.4%
9/121 • Number of events 11
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
General disorders
PAIN
|
5.7%
7/123 • Number of events 8
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
6.6%
8/121 • Number of events 8
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
General disorders
PYREXIA
|
25.2%
31/123 • Number of events 51
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
15.7%
19/121 • Number of events 28
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Hepatobiliary disorders
HEPATOTOXICITY
|
5.7%
7/123 • Number of events 8
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.00%
0/121
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Infections and infestations
BRONCHITIS
|
8.9%
11/123 • Number of events 13
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
5.0%
6/121 • Number of events 12
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Infections and infestations
HERPES ZOSTER
|
4.9%
6/123 • Number of events 6
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
6.6%
8/121 • Number of events 9
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Infections and infestations
INFLUENZA
|
4.9%
6/123 • Number of events 7
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
8.3%
10/121 • Number of events 10
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
5.7%
7/123 • Number of events 11
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
1.7%
2/121 • Number of events 2
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
6.5%
8/123 • Number of events 8
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
2.5%
3/121 • Number of events 3
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
10.6%
13/123 • Number of events 16
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
7.4%
9/121 • Number of events 14
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
5.7%
7/123 • Number of events 12
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
5.8%
7/121 • Number of events 9
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
6.5%
8/123 • Number of events 8
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.00%
0/121
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
6.5%
8/123 • Number of events 8
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
0.83%
1/121 • Number of events 1
Tables contain both treatment-emergent events (events that occurred after receiving study drug) and non-treatment emergent events (events that occurred prior to receiving study drug).
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The principal investigator (PI) agrees not to publish/publicly present any interim study results without the sponsor's prior written consent. The PI further agrees to provide 45 days written notice to the sponsor prior to submission for publication/presentation to permit the sponsor to review copies of abstracts or manuscripts for publication which report any results of the Study. The sponsor shall have the right to review and comment on any presentation, which shall include editorial rights.
- Publication restrictions are in place
Restriction type: OTHER