Trial Outcomes & Findings for Efficacy of Peginterferon Alfa-2b (SCH 054031) vs Glycyrrhizin in Interferon (IFN)-Treated Patients With Chronic Hepatitis C and F2/F3 Liver Fibrosis (P04773) (NCT NCT00686881)
NCT ID: NCT00686881
Last Updated: 2017-04-06
Results Overview
Metavir fibrosis score is a 5-point scale based on the amount of fibrosis in the liver, ranging from F0 (best, no fibrosis) to F4 (worst, cirrhosis).
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
261 participants
Primary outcome timeframe
Baseline and discontinuation of treatment (up to 156 weeks)
Results posted on
2017-04-06
Participant Flow
Participant milestones
| Measure |
PegIFN-2b
Participants receiving peginterferon alfa-2b (PegIFN-2b) at 0.5 ug/kg subcutaneously (SC) once a week for up to 156 weeks.
|
SNMC
Participants receiving stronger neo minophagen C (SNMC) 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for up to 156 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
127
|
134
|
|
Overall Study
COMPLETED
|
45
|
53
|
|
Overall Study
NOT COMPLETED
|
82
|
81
|
Reasons for withdrawal
| Measure |
PegIFN-2b
Participants receiving peginterferon alfa-2b (PegIFN-2b) at 0.5 ug/kg subcutaneously (SC) once a week for up to 156 weeks.
|
SNMC
Participants receiving stronger neo minophagen C (SNMC) 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for up to 156 weeks.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
11
|
18
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Treatment-related adverse event
|
10
|
9
|
|
Overall Study
Met discontinuation criteria
|
5
|
0
|
|
Overall Study
Onset of malignant tumor
|
11
|
11
|
|
Overall Study
Lack of Efficacy
|
4
|
3
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Circumstances of site
|
1
|
1
|
|
Overall Study
Did not meet protocol eligibility
|
1
|
0
|
|
Overall Study
Irregular visits
|
1
|
0
|
|
Overall Study
Study discontinuation
|
35
|
32
|
|
Overall Study
Never received study drug
|
2
|
6
|
Baseline Characteristics
Efficacy of Peginterferon Alfa-2b (SCH 054031) vs Glycyrrhizin in Interferon (IFN)-Treated Patients With Chronic Hepatitis C and F2/F3 Liver Fibrosis (P04773)
Baseline characteristics by cohort
| Measure |
PegIFN-2b
n=125 Participants
Participants receiving peginterferon alfa-2b (PegIFN-2b) at 0.5 ug/kg subcutaneously (SC) once a week for up to 156 weeks.
|
SNMC
n=127 Participants
Participants receiving stronger neo minophagen C (SNMC) 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for up to 156 weeks.
|
Total
n=252 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.8 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
60.7 years
STANDARD_DEVIATION 8.9 • n=7 Participants
|
60.3 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
125 participants
n=5 Participants
|
127 participants
n=7 Participants
|
252 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and discontinuation of treatment (up to 156 weeks)Population: All treated participants excluding 2 participants on the PegIFN-2B arm and 1 participant on the SNMC arm for whom baseline data were non-evaluable or for whom no post-baseline data were available.
Metavir fibrosis score is a 5-point scale based on the amount of fibrosis in the liver, ranging from F0 (best, no fibrosis) to F4 (worst, cirrhosis).
Outcome measures
| Measure |
PegIFN-2b
n=123 Participants
Participants receiving peginterferon alfa-2b (PegIFN-2b) at 0.5 ug/kg subcutaneously (SC) once a week for up to 156 weeks.
|
SNMC
n=126 Participants
Participants receiving stronger neo minophagen C (SNMC) 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for up to 156 weeks.
|
|---|---|---|
|
Number of Participants With Change in Metavir Fibrosis Score
Participants with ≥1grade lower score (improved)
|
13 Participants
|
11 Participants
|
|
Number of Participants With Change in Metavir Fibrosis Score
Participants with no change in score
|
79 Participants
|
79 Participants
|
|
Number of Participants With Change in Metavir Fibrosis Score
Participants with ≥1 grade higher score (worsened)
|
31 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: Week 24Population: All treated participants except 1 SNMC participant who had no available data after initial treatment.
The ALT was judged to have been normalized when the ALT level was 35 IU/L or below.
Outcome measures
| Measure |
PegIFN-2b
n=125 Participants
Participants receiving peginterferon alfa-2b (PegIFN-2b) at 0.5 ug/kg subcutaneously (SC) once a week for up to 156 weeks.
|
SNMC
n=127 Participants
Participants receiving stronger neo minophagen C (SNMC) 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for up to 156 weeks.
|
|---|---|---|
|
Number of Participants With Alanine Aminotransferase (ALT) Normalization of >16 Weeks Duration
|
9 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 48Population: All treated participants excluding 3 participants on the PegIFN-2b arm and 1 participant on the SNMC arm for whom baseline data were non-evaluable or for whom no post-baseline data were available.
Metavir inflammation score is a 4-point scale based on the severity of inflammation in the liver, ranging from A0 (best, no activity) to A3 (worst, severe activity).
Outcome measures
| Measure |
PegIFN-2b
n=122 Participants
Participants receiving peginterferon alfa-2b (PegIFN-2b) at 0.5 ug/kg subcutaneously (SC) once a week for up to 156 weeks.
|
SNMC
n=126 Participants
Participants receiving stronger neo minophagen C (SNMC) 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for up to 156 weeks.
|
|---|---|---|
|
Number of Participants With Change in Metavir Inflammation Score
Participants with ≥1grade lower score (improved)
|
48 Participants
|
23 Participants
|
|
Number of Participants With Change in Metavir Inflammation Score
Participants with no change in score
|
55 Participants
|
61 Participants
|
|
Number of Participants With Change in Metavir Inflammation Score
Participants with ≥1grade higher score (worsened)
|
19 Participants
|
42 Participants
|
Adverse Events
PegIFN-2b
Serious events: 32 serious events
Other events: 125 other events
Deaths: 0 deaths
SNMC
Serious events: 23 serious events
Other events: 123 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PegIFN-2b
n=125 participants at risk
Participants receiving PegIFN-2b at 0.5 ug/kg subcutaneously (SC) once a week for
up to 156 weeks.
|
SNMC
n=127 participants at risk
Participants receiving SNMC 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for up
to 156 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
IDIOPATHIC THROMBOCYTOPENIC PURPURA
|
0.00%
0/125
All treated participants except one SNMC participant who had no available data after initial treatment.
|
0.79%
1/127 • Number of events 1
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Cardiac disorders
PRINZMETAL ANGINA
|
0.00%
0/125
All treated participants except one SNMC participant who had no available data after initial treatment.
|
0.79%
1/127 • Number of events 1
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Ear and labyrinth disorders
DEAFNESS NEUROSENSORY
|
0.80%
1/125 • Number of events 1
All treated participants except one SNMC participant who had no available data after initial treatment.
|
0.00%
0/127
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Ear and labyrinth disorders
MENIERE'S DISEASE
|
0.80%
1/125 • Number of events 1
All treated participants except one SNMC participant who had no available data after initial treatment.
|
0.00%
0/127
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Gastrointestinal disorders
COLONIC POLYP
|
0.00%
0/125
All treated participants except one SNMC participant who had no available data after initial treatment.
|
0.79%
1/127 • Number of events 1
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Gastrointestinal disorders
DUODENAL ULCER
|
0.80%
1/125 • Number of events 1
All treated participants except one SNMC participant who had no available data after initial treatment.
|
0.00%
0/127
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Gastrointestinal disorders
GINGIVAL BLEEDING
|
0.80%
1/125 • Number of events 1
All treated participants except one SNMC participant who had no available data after initial treatment.
|
0.00%
0/127
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.80%
1/125 • Number of events 1
All treated participants except one SNMC participant who had no available data after initial treatment.
|
0.00%
0/127
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Gastrointestinal disorders
PANCREATITIS ACUTE
|
0.80%
1/125 • Number of events 1
All treated participants except one SNMC participant who had no available data after initial treatment.
|
0.00%
0/127
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Gastrointestinal disorders
VARICES OESOPHAGEAL
|
0.80%
1/125 • Number of events 1
All treated participants except one SNMC participant who had no available data after initial treatment.
|
0.00%
0/127
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
General disorders
PYREXIA
|
0.80%
1/125 • Number of events 1
All treated participants except one SNMC participant who had no available data after initial treatment.
|
0.00%
0/127
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Infections and infestations
APPENDICITIS
|
0.80%
1/125 • Number of events 1
All treated participants except one SNMC participant who had no available data after initial treatment.
|
0.00%
0/127
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Infections and infestations
BRONCHIECTASIS
|
0.80%
1/125 • Number of events 1
All treated participants except one SNMC participant who had no available data after initial treatment.
|
0.00%
0/127
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Infections and infestations
BRONCHOPNEUMONIA
|
0.80%
1/125 • Number of events 1
All treated participants except one SNMC participant who had no available data after initial treatment.
|
0.00%
0/127
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Infections and infestations
PYELONEPHRITIS
|
0.80%
1/125 • Number of events 1
All treated participants except one SNMC participant who had no available data after initial treatment.
|
0.00%
0/127
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Infections and infestations
PYELONEPHRITIS ACUTE
|
0.80%
1/125 • Number of events 1
All treated participants except one SNMC participant who had no available data after initial treatment.
|
0.00%
0/127
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Infections and infestations
SEPSIS
|
0.00%
0/125
All treated participants except one SNMC participant who had no available data after initial treatment.
|
0.79%
1/127 • Number of events 1
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Injury, poisoning and procedural complications
ANKLE FRACTURE
|
0.80%
1/125 • Number of events 1
All treated participants except one SNMC participant who had no available data after initial treatment.
|
0.00%
0/127
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Injury, poisoning and procedural complications
FRACTURED SACRUM
|
0.80%
1/125 • Number of events 1
All treated participants except one SNMC participant who had no available data after initial treatment.
|
0.00%
0/127
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Injury, poisoning and procedural complications
HAND FRACTURE
|
0.80%
1/125 • Number of events 1
All treated participants except one SNMC participant who had no available data after initial treatment.
|
0.00%
0/127
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Injury, poisoning and procedural complications
HUMERUS FRACTURE
|
0.00%
0/125
All treated participants except one SNMC participant who had no available data after initial treatment.
|
0.79%
1/127 • Number of events 1
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Injury, poisoning and procedural complications
LOWER LIMB FRACTURE
|
0.80%
1/125 • Number of events 1
All treated participants except one SNMC participant who had no available data after initial treatment.
|
0.00%
0/127
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Injury, poisoning and procedural complications
MENISCUS LESION
|
0.00%
0/125
All treated participants except one SNMC participant who had no available data after initial treatment.
|
0.79%
1/127 • Number of events 1
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL HAEMORRHAGE
|
0.80%
1/125 • Number of events 1
All treated participants except one SNMC participant who had no available data after initial treatment.
|
0.00%
0/127
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Injury, poisoning and procedural complications
SKIN LACERATION
|
0.80%
1/125 • Number of events 1
All treated participants except one SNMC participant who had no available data after initial treatment.
|
0.00%
0/127
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Injury, poisoning and procedural complications
SUBDURAL HAEMATOMA
|
0.80%
1/125 • Number of events 1
All treated participants except one SNMC participant who had no available data after initial treatment.
|
0.79%
1/127 • Number of events 1
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Injury, poisoning and procedural complications
TENDON RUPTURE
|
0.00%
0/125
All treated participants except one SNMC participant who had no available data after initial treatment.
|
0.79%
1/127 • Number of events 1
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
0.80%
1/125 • Number of events 1
All treated participants except one SNMC participant who had no available data after initial treatment.
|
0.00%
0/127
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
0.80%
1/125 • Number of events 1
All treated participants except one SNMC participant who had no available data after initial treatment.
|
0.79%
1/127 • Number of events 1
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
GASTRIC CANCER
|
0.00%
0/125
All treated participants except one SNMC participant who had no available data after initial treatment.
|
0.79%
1/127 • Number of events 1
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HEPATIC NEOPLASM MALIGNANT
|
6.4%
8/125 • Number of events 8
All treated participants except one SNMC participant who had no available data after initial treatment.
|
7.9%
10/127 • Number of events 10
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LARGE INTESTINE CARCINOMA
|
0.80%
1/125 • Number of events 1
All treated participants except one SNMC participant who had no available data after initial treatment.
|
0.00%
0/127
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO LUNG
|
0.80%
1/125 • Number of events 1
All treated participants except one SNMC participant who had no available data after initial treatment.
|
0.00%
0/127
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
OVARIAN NEOPLASM
|
0.00%
0/125
All treated participants except one SNMC participant who had no available data after initial treatment.
|
0.79%
1/127 • Number of events 1
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PANCREATIC CARCINOMA
|
0.80%
1/125 • Number of events 1
All treated participants except one SNMC participant who had no available data after initial treatment.
|
0.00%
0/127
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RECTAL CANCER
|
0.00%
0/125
All treated participants except one SNMC participant who had no available data after initial treatment.
|
0.79%
1/127 • Number of events 1
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RENAL CELL CARCINOMA
|
0.80%
1/125 • Number of events 1
All treated participants except one SNMC participant who had no available data after initial treatment.
|
0.00%
0/127
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Nervous system disorders
CEREBRAL HAEMORRHAGE
|
0.80%
1/125 • Number of events 1
All treated participants except one SNMC participant who had no available data after initial treatment.
|
0.79%
1/127 • Number of events 1
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Nervous system disorders
INTRAVENTRICULAR HAEMORRHAGE
|
0.00%
0/125
All treated participants except one SNMC participant who had no available data after initial treatment.
|
0.79%
1/127 • Number of events 1
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Nervous system disorders
LACUNAR INFARCTION
|
0.80%
1/125 • Number of events 1
All treated participants except one SNMC participant who had no available data after initial treatment.
|
0.00%
0/127
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Nervous system disorders
PARALYSIS
|
0.00%
0/125
All treated participants except one SNMC participant who had no available data after initial treatment.
|
0.79%
1/127 • Number of events 1
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Psychiatric disorders
ANXIETY DISORDER
|
0.00%
0/125
All treated participants except one SNMC participant who had no available data after initial treatment.
|
0.79%
1/127 • Number of events 1
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Renal and urinary disorders
CALCULUS URETERIC
|
0.80%
1/125 • Number of events 1
All treated participants except one SNMC participant who had no available data after initial treatment.
|
0.00%
0/127
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Skin and subcutaneous tissue disorders
PSORIASIS
|
0.80%
1/125 • Number of events 1
All treated participants except one SNMC participant who had no available data after initial treatment.
|
0.00%
0/127
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Vascular disorders
ANEURYSM RUPTURED
|
0.80%
1/125 • Number of events 1
All treated participants except one SNMC participant who had no available data after initial treatment.
|
0.00%
0/127
All treated participants except one SNMC participant who had no available data after initial treatment.
|
Other adverse events
| Measure |
PegIFN-2b
n=125 participants at risk
Participants receiving PegIFN-2b at 0.5 ug/kg subcutaneously (SC) once a week for
up to 156 weeks.
|
SNMC
n=127 participants at risk
Participants receiving SNMC 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for up
to 156 weeks.
|
|---|---|---|
|
Cardiac disorders
PALPITATIONS
|
6.4%
8/125 • Number of events 13
All treated participants except one SNMC participant who had no available data after initial treatment.
|
4.7%
6/127 • Number of events 7
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Eye disorders
ASTHENOPIA
|
5.6%
7/125 • Number of events 7
All treated participants except one SNMC participant who had no available data after initial treatment.
|
3.1%
4/127 • Number of events 4
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Eye disorders
CONJUNCTIVITIS
|
10.4%
13/125 • Number of events 19
All treated participants except one SNMC participant who had no available data after initial treatment.
|
1.6%
2/127 • Number of events 2
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
12.8%
16/125 • Number of events 21
All treated participants except one SNMC participant who had no available data after initial treatment.
|
7.1%
9/127 • Number of events 16
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
5.6%
7/125 • Number of events 9
All treated participants except one SNMC participant who had no available data after initial treatment.
|
2.4%
3/127 • Number of events 4
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
28.0%
35/125 • Number of events 79
All treated participants except one SNMC participant who had no available data after initial treatment.
|
17.3%
22/127 • Number of events 32
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
11.2%
14/125 • Number of events 15
All treated participants except one SNMC participant who had no available data after initial treatment.
|
11.0%
14/127 • Number of events 21
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Gastrointestinal disorders
CONSTIPATION
|
25.6%
32/125 • Number of events 40
All treated participants except one SNMC participant who had no available data after initial treatment.
|
7.9%
10/127 • Number of events 10
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Gastrointestinal disorders
DENTAL CARIES
|
5.6%
7/125 • Number of events 10
All treated participants except one SNMC participant who had no available data after initial treatment.
|
6.3%
8/127 • Number of events 8
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Gastrointestinal disorders
DIARRHOEA
|
28.0%
35/125 • Number of events 63
All treated participants except one SNMC participant who had no available data after initial treatment.
|
13.4%
17/127 • Number of events 31
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Gastrointestinal disorders
NAUSEA
|
32.0%
40/125 • Number of events 76
All treated participants except one SNMC participant who had no available data after initial treatment.
|
15.7%
20/127 • Number of events 22
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Gastrointestinal disorders
PERIODONTITIS
|
6.4%
8/125 • Number of events 8
All treated participants except one SNMC participant who had no available data after initial treatment.
|
4.7%
6/127 • Number of events 6
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Gastrointestinal disorders
STOMATITIS
|
12.0%
15/125 • Number of events 22
All treated participants except one SNMC participant who had no available data after initial treatment.
|
5.5%
7/127 • Number of events 11
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Gastrointestinal disorders
TOOTHACHE
|
4.8%
6/125 • Number of events 6
All treated participants except one SNMC participant who had no available data after initial treatment.
|
6.3%
8/127 • Number of events 12
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Gastrointestinal disorders
VOMITING
|
7.2%
9/125 • Number of events 10
All treated participants except one SNMC participant who had no available data after initial treatment.
|
7.1%
9/127 • Number of events 10
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
General disorders
CHILLS
|
40.0%
50/125 • Number of events 76
All treated participants except one SNMC participant who had no available data after initial treatment.
|
9.4%
12/127 • Number of events 14
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
General disorders
INJECTION SITE ERYTHEMA
|
27.2%
34/125 • Number of events 43
All treated participants except one SNMC participant who had no available data after initial treatment.
|
0.79%
1/127 • Number of events 1
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
General disorders
INJECTION SITE PRURITUS
|
36.0%
45/125 • Number of events 61
All treated participants except one SNMC participant who had no available data after initial treatment.
|
2.4%
3/127 • Number of events 4
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
General disorders
MALAISE
|
77.6%
97/125 • Number of events 166
All treated participants except one SNMC participant who had no available data after initial treatment.
|
40.2%
51/127 • Number of events 81
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
General disorders
OEDEMA PERIPHERAL
|
7.2%
9/125 • Number of events 9
All treated participants except one SNMC participant who had no available data after initial treatment.
|
9.4%
12/127 • Number of events 13
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
General disorders
PYREXIA
|
69.6%
87/125 • Number of events 171
All treated participants except one SNMC participant who had no available data after initial treatment.
|
19.7%
25/127 • Number of events 36
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
General disorders
THIRST
|
4.8%
6/125 • Number of events 6
All treated participants except one SNMC participant who had no available data after initial treatment.
|
7.1%
9/127 • Number of events 12
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Infections and infestations
CYSTITIS
|
5.6%
7/125 • Number of events 10
All treated participants except one SNMC participant who had no available data after initial treatment.
|
3.9%
5/127 • Number of events 7
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Infections and infestations
GASTROENTERITIS
|
3.2%
4/125 • Number of events 6
All treated participants except one SNMC participant who had no available data after initial treatment.
|
6.3%
8/127 • Number of events 10
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Infections and infestations
NASOPHARYNGITIS
|
61.6%
77/125 • Number of events 157
All treated participants except one SNMC participant who had no available data after initial treatment.
|
63.8%
81/127 • Number of events 256
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Infections and infestations
ORAL HERPES
|
5.6%
7/125 • Number of events 9
All treated participants except one SNMC participant who had no available data after initial treatment.
|
3.1%
4/127 • Number of events 6
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Injury, poisoning and procedural complications
CONTUSION
|
10.4%
13/125 • Number of events 18
All treated participants except one SNMC participant who had no available data after initial treatment.
|
4.7%
6/127 • Number of events 9
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Injury, poisoning and procedural complications
PROCEDURAL PAIN
|
12.0%
15/125 • Number of events 16
All treated participants except one SNMC participant who had no available data after initial treatment.
|
9.4%
12/127 • Number of events 13
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Injury, poisoning and procedural complications
TOOTH FRACTURE
|
7.2%
9/125 • Number of events 10
All treated participants except one SNMC participant who had no available data after initial treatment.
|
0.79%
1/127 • Number of events 1
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
27.2%
34/125 • Number of events 42
All treated participants except one SNMC participant who had no available data after initial treatment.
|
12.6%
16/127 • Number of events 21
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Investigations
ALPHA 1 FOETOPROTEIN INCREASED
|
3.2%
4/125 • Number of events 6
All treated participants except one SNMC participant who had no available data after initial treatment.
|
7.1%
9/127 • Number of events 10
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
37.6%
47/125 • Number of events 58
All treated participants except one SNMC participant who had no available data after initial treatment.
|
16.5%
21/127 • Number of events 26
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Investigations
BASOPHIL COUNT INCREASED
|
14.4%
18/125 • Number of events 42
All treated participants except one SNMC participant who had no available data after initial treatment.
|
21.3%
27/127 • Number of events 46
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Investigations
BILIRUBIN CONJUGATED INCREASED
|
4.0%
5/125 • Number of events 5
All treated participants except one SNMC participant who had no available data after initial treatment.
|
7.9%
10/127 • Number of events 19
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
9.6%
12/125 • Number of events 16
All treated participants except one SNMC participant who had no available data after initial treatment.
|
12.6%
16/127 • Number of events 24
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
2.4%
3/125 • Number of events 3
All treated participants except one SNMC participant who had no available data after initial treatment.
|
6.3%
8/127 • Number of events 13
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Investigations
BLOOD POTASSIUM DECREASED
|
9.6%
12/125 • Number of events 15
All treated participants except one SNMC participant who had no available data after initial treatment.
|
13.4%
17/127 • Number of events 27
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Investigations
BLOOD POTASSIUM INCREASED
|
4.0%
5/125 • Number of events 6
All treated participants except one SNMC participant who had no available data after initial treatment.
|
6.3%
8/127 • Number of events 10
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Investigations
BLOOD PRESSURE INCREASED
|
9.6%
12/125 • Number of events 15
All treated participants except one SNMC participant who had no available data after initial treatment.
|
17.3%
22/127 • Number of events 28
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Investigations
BLOOD THYROID STIMULATING HORMONE INCREASED
|
23.2%
29/125 • Number of events 38
All treated participants except one SNMC participant who had no available data after initial treatment.
|
11.0%
14/127 • Number of events 19
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Investigations
C-REACTIVE PROTEIN INCREASED
|
12.8%
16/125 • Number of events 18
All treated participants except one SNMC participant who had no available data after initial treatment.
|
11.0%
14/127 • Number of events 19
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Investigations
EOSINOPHIL COUNT INCREASED
|
25.6%
32/125 • Number of events 52
All treated participants except one SNMC participant who had no available data after initial treatment.
|
25.2%
32/127 • Number of events 53
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
24.0%
30/125 • Number of events 37
All treated participants except one SNMC participant who had no available data after initial treatment.
|
18.1%
23/127 • Number of events 32
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Investigations
HAEMATOCRIT DECREASED
|
32.0%
40/125 • Number of events 60
All treated participants except one SNMC participant who had no available data after initial treatment.
|
7.9%
10/127 • Number of events 11
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Investigations
HAEMOGLOBIN DECREASED
|
32.8%
41/125 • Number of events 52
All treated participants except one SNMC participant who had no available data after initial treatment.
|
8.7%
11/127 • Number of events 13
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Investigations
HYALURONIC ACID INCREASED
|
49.6%
62/125 • Number of events 90
All treated participants except one SNMC participant who had no available data after initial treatment.
|
36.2%
46/127 • Number of events 70
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
64.0%
80/125 • Number of events 134
All treated participants except one SNMC participant who had no available data after initial treatment.
|
35.4%
45/127 • Number of events 107
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Investigations
LYMPHOCYTE COUNT INCREASED
|
22.4%
28/125 • Number of events 51
All treated participants except one SNMC participant who had no available data after initial treatment.
|
26.8%
34/127 • Number of events 69
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Investigations
MONOCYTE COUNT INCREASED
|
10.4%
13/125 • Number of events 14
All treated participants except one SNMC participant who had no available data after initial treatment.
|
6.3%
8/127 • Number of events 13
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
49.6%
62/125 • Number of events 111
All treated participants except one SNMC participant who had no available data after initial treatment.
|
7.1%
9/127 • Number of events 12
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Investigations
NEUTROPHIL COUNT INCREASED
|
24.8%
31/125 • Number of events 48
All treated participants except one SNMC participant who had no available data after initial treatment.
|
39.4%
50/127 • Number of events 77
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Investigations
PLATELET COUNT DECREASED
|
59.2%
74/125 • Number of events 109
All treated participants except one SNMC participant who had no available data after initial treatment.
|
15.0%
19/127 • Number of events 24
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Investigations
RED BLOOD CELL COUNT DECREASED
|
32.8%
41/125 • Number of events 57
All treated participants except one SNMC participant who had no available data after initial treatment.
|
5.5%
7/127 • Number of events 7
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Investigations
TRI-IODOTHYRONINE FREE DECREASED
|
8.8%
11/125 • Number of events 12
All treated participants except one SNMC participant who had no available data after initial treatment.
|
4.7%
6/127 • Number of events 6
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Investigations
WEIGHT DECREASED
|
11.2%
14/125 • Number of events 14
All treated participants except one SNMC participant who had no available data after initial treatment.
|
3.9%
5/127 • Number of events 5
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Investigations
WHITE BLOOD CELL COUNT DECREASED
|
54.4%
68/125 • Number of events 104
All treated participants except one SNMC participant who had no available data after initial treatment.
|
7.1%
9/127 • Number of events 15
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Investigations
WHITE BLOOD CELL COUNT INCREASED
|
6.4%
8/125 • Number of events 13
All treated participants except one SNMC participant who had no available data after initial treatment.
|
16.5%
21/127 • Number of events 21
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
45.6%
57/125 • Number of events 91
All treated participants except one SNMC participant who had no available data after initial treatment.
|
17.3%
22/127 • Number of events 30
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
57.6%
72/125 • Number of events 123
All treated participants except one SNMC participant who had no available data after initial treatment.
|
24.4%
31/127 • Number of events 41
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
20.8%
26/125 • Number of events 35
All treated participants except one SNMC participant who had no available data after initial treatment.
|
24.4%
31/127 • Number of events 50
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
7.2%
9/125 • Number of events 16
All treated participants except one SNMC participant who had no available data after initial treatment.
|
10.2%
13/127 • Number of events 22
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
5.6%
7/125 • Number of events 7
All treated participants except one SNMC participant who had no available data after initial treatment.
|
7.1%
9/127 • Number of events 13
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL STIFFNESS
|
11.2%
14/125 • Number of events 16
All treated participants except one SNMC participant who had no available data after initial treatment.
|
5.5%
7/127 • Number of events 7
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
54.4%
68/125 • Number of events 108
All treated participants except one SNMC participant who had no available data after initial treatment.
|
18.9%
24/127 • Number of events 39
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
8.0%
10/125 • Number of events 10
All treated participants except one SNMC participant who had no available data after initial treatment.
|
7.1%
9/127 • Number of events 11
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Musculoskeletal and connective tissue disorders
TENOSYNOVITIS
|
1.6%
2/125 • Number of events 2
All treated participants except one SNMC participant who had no available data after initial treatment.
|
6.3%
8/127 • Number of events 8
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Nervous system disorders
DIZZINESS
|
15.2%
19/125 • Number of events 25
All treated participants except one SNMC participant who had no available data after initial treatment.
|
11.8%
15/127 • Number of events 21
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Nervous system disorders
HEADACHE
|
65.6%
82/125 • Number of events 164
All treated participants except one SNMC participant who had no available data after initial treatment.
|
33.1%
42/127 • Number of events 73
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Nervous system disorders
HYPOAESTHESIA
|
6.4%
8/125 • Number of events 8
All treated participants except one SNMC participant who had no available data after initial treatment.
|
6.3%
8/127 • Number of events 10
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Psychiatric disorders
INSOMNIA
|
39.2%
49/125 • Number of events 78
All treated participants except one SNMC participant who had no available data after initial treatment.
|
11.8%
15/127 • Number of events 17
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
10.4%
13/125 • Number of events 19
All treated participants except one SNMC participant who had no available data after initial treatment.
|
11.8%
15/127 • Number of events 17
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
8.8%
11/125 • Number of events 35
All treated participants except one SNMC participant who had no available data after initial treatment.
|
7.9%
10/127 • Number of events 17
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL DISCOMFORT
|
5.6%
7/125 • Number of events 7
All treated participants except one SNMC participant who had no available data after initial treatment.
|
1.6%
2/127 • Number of events 2
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
11.2%
14/125 • Number of events 28
All treated participants except one SNMC participant who had no available data after initial treatment.
|
9.4%
12/127 • Number of events 21
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Respiratory, thoracic and mediastinal disorders
UPPER RESPIRATORY TRACT INFLAMMATION
|
7.2%
9/125 • Number of events 12
All treated participants except one SNMC participant who had no available data after initial treatment.
|
8.7%
11/127 • Number of events 17
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
33.6%
42/125 • Number of events 51
All treated participants except one SNMC participant who had no available data after initial treatment.
|
2.4%
3/127 • Number of events 5
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS CONTACT
|
7.2%
9/125 • Number of events 11
All treated participants except one SNMC participant who had no available data after initial treatment.
|
6.3%
8/127 • Number of events 9
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
8.8%
11/125 • Number of events 14
All treated participants except one SNMC participant who had no available data after initial treatment.
|
9.4%
12/127 • Number of events 20
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
38.4%
48/125 • Number of events 94
All treated participants except one SNMC participant who had no available data after initial treatment.
|
18.9%
24/127 • Number of events 33
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Skin and subcutaneous tissue disorders
PRURITUS GENERALISED
|
9.6%
12/125 • Number of events 19
All treated participants except one SNMC participant who had no available data after initial treatment.
|
5.5%
7/127 • Number of events 8
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Skin and subcutaneous tissue disorders
RASH
|
33.6%
42/125 • Number of events 53
All treated participants except one SNMC participant who had no available data after initial treatment.
|
14.2%
18/127 • Number of events 25
All treated participants except one SNMC participant who had no available data after initial treatment.
|
|
Vascular disorders
HYPERTENSION
|
10.4%
13/125 • Number of events 13
All treated participants except one SNMC participant who had no available data after initial treatment.
|
16.5%
21/127 • Number of events 23
All treated participants except one SNMC participant who had no available data after initial treatment.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp..
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place