Trial Outcomes & Findings for Algeron (Cepeginterferon Alfa-2b) Compared With PegIntron (Peginterferon Alfa-2b) for Treatment of Chronic Hepatitis C (NCT NCT01740089)
NCT ID: NCT01740089
Last Updated: 2015-08-18
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
150 participants
Primary outcome timeframe
12 weeks
Results posted on
2015-08-18
Participant Flow
Participant milestones
| Measure |
Algeron 1.5 μg/kg
Algeron 1.5 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight \< 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight \> 105 kg).
Algeron: 1.5 μg/kg or 2.0 μg/kg of body weight weekly subcutaneously
|
Algeron 2.0 μg/kg
Algeron 2.0 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight \< 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight \> 105 kg).
Algeron: 1.5 μg/kg or 2.0 μg/kg of body weight weekly subcutaneously
|
PegIntron
PegIntron 1.5 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight \< 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight \> 105 kg).
PegIntron: 1.5 μg/kg/week subcutaneously in combination with ribavirin
|
|---|---|---|---|
|
First 12 Weeks of Treatment
STARTED
|
50
|
50
|
50
|
|
First 12 Weeks of Treatment
COMPLETED
|
50
|
48
|
48
|
|
First 12 Weeks of Treatment
NOT COMPLETED
|
0
|
2
|
2
|
|
After 12 Weeks
STARTED
|
50
|
48
|
48
|
|
After 12 Weeks
COMPLETED
|
43
|
45
|
37
|
|
After 12 Weeks
NOT COMPLETED
|
7
|
3
|
11
|
Reasons for withdrawal
| Measure |
Algeron 1.5 μg/kg
Algeron 1.5 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight \< 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight \> 105 kg).
Algeron: 1.5 μg/kg or 2.0 μg/kg of body weight weekly subcutaneously
|
Algeron 2.0 μg/kg
Algeron 2.0 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight \< 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight \> 105 kg).
Algeron: 1.5 μg/kg or 2.0 μg/kg of body weight weekly subcutaneously
|
PegIntron
PegIntron 1.5 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight \< 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight \> 105 kg).
PegIntron: 1.5 μg/kg/week subcutaneously in combination with ribavirin
|
|---|---|---|---|
|
First 12 Weeks of Treatment
Adverse Event
|
0
|
1
|
2
|
|
First 12 Weeks of Treatment
Withdrawal by Subject
|
0
|
1
|
0
|
|
After 12 Weeks
Lack of Efficacy
|
3
|
1
|
4
|
|
After 12 Weeks
Adverse Event
|
2
|
0
|
5
|
|
After 12 Weeks
Protocol Violation
|
1
|
1
|
1
|
|
After 12 Weeks
Withdrawal by Subject
|
1
|
1
|
1
|
Baseline Characteristics
Algeron (Cepeginterferon Alfa-2b) Compared With PegIntron (Peginterferon Alfa-2b) for Treatment of Chronic Hepatitis C
Baseline characteristics by cohort
| Measure |
Algeron 1.5 μg/kg
n=50 Participants
Algeron 1.5 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight \< 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight \> 105 kg).
Algeron: 1.5 μg/kg or 2.0 μg/kg of body weight weekly subcutaneously
|
Algeron 2.0 μg/kg
n=50 Participants
Algeron 2.0 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight \< 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight \> 105 kg).
Algeron: 1.5 μg/kg or 2.0 μg/kg of body weight weekly subcutaneously
|
PegIntron
n=50 Participants
PegIntron 1.5 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight \< 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight \> 105 kg).
PegIntron: 1.5 μg/kg/week subcutaneously in combination with ribavirin
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
35 years
n=5 Participants
|
34 years
n=7 Participants
|
36 years
n=5 Participants
|
35 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
106 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
50 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
149 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Russian Federation
|
50 participants
n=5 Participants
|
50 participants
n=7 Participants
|
50 participants
n=5 Participants
|
150 participants
n=4 Participants
|
|
HCV genotype
HCV 1b
|
22 participants
n=5 Participants
|
26 participants
n=7 Participants
|
26 participants
n=5 Participants
|
74 participants
n=4 Participants
|
|
HCV genotype
HCV 1a
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
7 participants
n=4 Participants
|
|
HCV genotype
HCV 2
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
5 participants
n=4 Participants
|
|
HCV genotype
HCV 3
|
22 participants
n=5 Participants
|
21 participants
n=7 Participants
|
21 participants
n=5 Participants
|
64 participants
n=4 Participants
|
|
Initial Viral load
High (>8х10^5 IU/ml)
|
17 participants
n=5 Participants
|
16 participants
n=7 Participants
|
14 participants
n=5 Participants
|
47 participants
n=4 Participants
|
|
Initial Viral load
Low (≤8х10^5 IU/ml)
|
33 participants
n=5 Participants
|
34 participants
n=7 Participants
|
36 participants
n=5 Participants
|
103 participants
n=4 Participants
|
|
Interleukin 28B (IL-28B) genotype
C/C
|
19 participants
n=5 Participants
|
17 participants
n=7 Participants
|
13 participants
n=5 Participants
|
49 participants
n=4 Participants
|
|
Interleukin 28B (IL-28B) genotype
C/T
|
24 participants
n=5 Participants
|
26 participants
n=7 Participants
|
26 participants
n=5 Participants
|
76 participants
n=4 Participants
|
|
Interleukin 28B (IL-28B) genotype
T/T
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
11 participants
n=5 Participants
|
25 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 12 weeksOutcome measures
| Measure |
Algeron 1.5 μg/kg
n=50 Participants
Algeron 1.5 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight \< 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight \> 105 kg).
Algeron: 1.5 μg/kg or 2.0 μg/kg of body weight weekly subcutaneously
|
Algeron 2.0 μg/kg
n=50 Participants
Algeron 2.0 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight \< 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight \> 105 kg).
Algeron: 1.5 μg/kg or 2.0 μg/kg of body weight weekly subcutaneously
|
PegIntron
n=50 Participants
PegIntron 1.5 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight \< 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight \> 105 kg).
PegIntron: 1.5 μg/kg/week subcutaneously in combination with ribavirin
|
|---|---|---|---|
|
Number of Randomized Patients Achieving Early Virologic Response (EVR) - Negative PCR Result for HCV RNA (< 15 IU/ml) or ≥ 2log10 Decrease of Viral Load After 12 Weeks of Study Treatment.
|
47 participants
|
47 participants
|
44 participants
|
SECONDARY outcome
Timeframe: 4 weeksOutcome measures
| Measure |
Algeron 1.5 μg/kg
n=50 Participants
Algeron 1.5 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight \< 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight \> 105 kg).
Algeron: 1.5 μg/kg or 2.0 μg/kg of body weight weekly subcutaneously
|
Algeron 2.0 μg/kg
n=50 Participants
Algeron 2.0 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight \< 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight \> 105 kg).
Algeron: 1.5 μg/kg or 2.0 μg/kg of body weight weekly subcutaneously
|
PegIntron
n=50 Participants
PegIntron 1.5 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight \< 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight \> 105 kg).
PegIntron: 1.5 μg/kg/week subcutaneously in combination with ribavirin
|
|---|---|---|---|
|
Number of Randomized Patients Achieving Rapid Virologic Response (RVR) - Negative PCR Result for HCV RNA (< 15 IU/ml) After 4 Weeks of Treatment.
|
32 participants
|
28 participants
|
33 participants
|
SECONDARY outcome
Timeframe: 24 weeks after last dose of study treatmentOutcome measures
| Measure |
Algeron 1.5 μg/kg
n=100 Participants
Algeron 1.5 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight \< 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight \> 105 kg).
Algeron: 1.5 μg/kg or 2.0 μg/kg of body weight weekly subcutaneously
|
Algeron 2.0 μg/kg
n=50 Participants
Algeron 2.0 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight \< 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight \> 105 kg).
Algeron: 1.5 μg/kg or 2.0 μg/kg of body weight weekly subcutaneously
|
PegIntron
PegIntron 1.5 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight \< 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight \> 105 kg).
PegIntron: 1.5 μg/kg/week subcutaneously in combination with ribavirin
|
|---|---|---|---|
|
Number of Randomized Patients Achieving Sustained Virologic Response (SVR) - Negative PCR Result for HCV RNA (< 15 IU/ml) 24 Weeks After Last Dose of Study Treatment.
|
75 participants
|
34 participants
|
—
|
SECONDARY outcome
Timeframe: After 24 weeks of treatment for patients with genotype 2 or 3 and after 48 weeks of treatment for patients with genotype 1 or 4.Outcome measures
| Measure |
Algeron 1.5 μg/kg
n=100 Participants
Algeron 1.5 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight \< 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight \> 105 kg).
Algeron: 1.5 μg/kg or 2.0 μg/kg of body weight weekly subcutaneously
|
Algeron 2.0 μg/kg
n=50 Participants
Algeron 2.0 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight \< 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight \> 105 kg).
Algeron: 1.5 μg/kg or 2.0 μg/kg of body weight weekly subcutaneously
|
PegIntron
PegIntron 1.5 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight \< 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight \> 105 kg).
PegIntron: 1.5 μg/kg/week subcutaneously in combination with ribavirin
|
|---|---|---|---|
|
Number of Patients Who Have Undetectable HCV RNA (< 15 IU/ml) at the End of Treatment.
|
88 participants
|
38 participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Weeks 0, 12, 24, 48 (for patients with genotype 1 or 4) and 24 weeks after last dose of study treatmentNumber of randomized patients with neutralizing antibodies to IFN alfa on weeks 0, 12, 24, 48 (for patients with genotype 1 or 4) and 24 weeks after last dose of study treatment.
Outcome measures
| Measure |
Algeron 1.5 μg/kg
n=100 Participants
Algeron 1.5 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight \< 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight \> 105 kg).
Algeron: 1.5 μg/kg or 2.0 μg/kg of body weight weekly subcutaneously
|
Algeron 2.0 μg/kg
n=50 Participants
Algeron 2.0 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight \< 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight \> 105 kg).
Algeron: 1.5 μg/kg or 2.0 μg/kg of body weight weekly subcutaneously
|
PegIntron
PegIntron 1.5 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight \< 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight \> 105 kg).
PegIntron: 1.5 μg/kg/week subcutaneously in combination with ribavirin
|
|---|---|---|---|
|
Immunogenicity
|
0 participants
|
0 participants
|
—
|
Adverse Events
Algeron (n=101)
Serious events: 2 serious events
Other events: 101 other events
Deaths: 0 deaths
PegIntron (n=50)
Serious events: 2 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Algeron (n=101)
n=101 participants at risk
The safety analysis included 101 patients received at least 1 dose of Algeron (taking into account one patient withdrawn at early stages of the study due to a protocol violation \[severe depression by the Beck's scale before the first injection\], who was withdrawn from the mITT-analysis)
|
PegIntron (n=50)
n=50 participants at risk
|
|---|---|---|
|
Reproductive system and breast disorders
dysfunctional uterine bleeding
|
0.99%
1/101 • Number of events 1
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
0.00%
0/50
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
|
Blood and lymphatic system disorders
drug-induced pancytopenia
|
0.00%
0/101
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
2.0%
1/50 • Number of events 1
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
|
Surgical and medical procedures
phlegmonous appendicitis
|
0.99%
1/101 • Number of events 1
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
2.0%
1/50 • Number of events 1
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
Other adverse events
| Measure |
Algeron (n=101)
n=101 participants at risk
The safety analysis included 101 patients received at least 1 dose of Algeron (taking into account one patient withdrawn at early stages of the study due to a protocol violation \[severe depression by the Beck's scale before the first injection\], who was withdrawn from the mITT-analysis)
|
PegIntron (n=50)
n=50 participants at risk
|
|---|---|---|
|
General disorders
Flu-like syndrome
|
85.1%
86/101 • Number of events 86
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
98.0%
49/50 • Number of events 49
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
|
General disorders
Asthenia (weakness, fatigue)
|
62.4%
63/101 • Number of events 63
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
44.0%
22/50 • Number of events 22
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
|
General disorders
Grade I decreased body weight
|
24.8%
25/101 • Number of events 25
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
24.0%
12/50 • Number of events 12
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
|
General disorders
Grade II decreased body weight
|
10.9%
11/101 • Number of events 11
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
16.0%
8/50 • Number of events 8
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
|
Nervous system disorders
Headache
|
51.5%
52/101 • Number of events 52
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
64.0%
32/50 • Number of events 32
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
|
Nervous system disorders
Dizziness
|
11.9%
12/101 • Number of events 12
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
10.0%
5/50 • Number of events 5
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
|
Psychiatric disorders
Depression
|
12.9%
13/101 • Number of events 13
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
6.0%
3/50 • Number of events 3
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
|
Psychiatric disorders
Irritability, emotional lability
|
14.9%
15/101 • Number of events 15
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
8.0%
4/50 • Number of events 4
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
|
Psychiatric disorders
Sleep disorders
|
8.9%
9/101 • Number of events 9
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
8.0%
4/50 • Number of events 4
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
|
Gastrointestinal disorders
Nausea
|
13.9%
14/101 • Number of events 14
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
14.0%
7/50 • Number of events 7
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
6/101 • Number of events 6
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
6.0%
3/50 • Number of events 3
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
|
Gastrointestinal disorders
Stomach pain
|
8.9%
9/101 • Number of events 9
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
6.0%
3/50 • Number of events 3
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
|
Gastrointestinal disorders
Decreased appetite
|
9.9%
10/101 • Number of events 10
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
20.0%
10/50 • Number of events 10
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
|
Gastrointestinal disorders
Dry mouth
|
7.9%
8/101 • Number of events 8
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
4.0%
2/50 • Number of events 2
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
|
Gastrointestinal disorders
Diarrhea
|
16.8%
17/101 • Number of events 17
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
8.0%
4/50 • Number of events 4
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
|
Respiratory, thoracic and mediastinal disorders
Dry cough
|
15.8%
16/101 • Number of events 16
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
10.0%
5/50 • Number of events 5
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoe (including dyspnoe after exercises)
|
6.9%
7/101 • Number of events 7
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
0.00%
0/50
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
29.7%
30/101 • Number of events 30
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
48.0%
24/50 • Number of events 24
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
32.7%
33/101 • Number of events 33
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
32.0%
16/50 • Number of events 16
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
26.7%
27/101 • Number of events 27
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
24.0%
12/50 • Number of events 12
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
|
Skin and subcutaneous tissue disorders
Skin itch
|
20.8%
21/101 • Number of events 21
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
14.0%
7/50 • Number of events 7
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
|
Skin and subcutaneous tissue disorders
Rash
|
13.9%
14/101 • Number of events 14
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
12.0%
6/50 • Number of events 6
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
|
Skin and subcutaneous tissue disorders
Skin dryness and exfoliation
|
22.8%
23/101 • Number of events 23
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
14.0%
7/50 • Number of events 7
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
|
Skin and subcutaneous tissue disorders
Stomatitis and gingivitis
|
7.9%
8/101 • Number of events 8
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
6.0%
3/50 • Number of events 3
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
|
Skin and subcutaneous tissue disorders
Blepharitis and conjunctivitis
|
9.9%
10/101 • Number of events 10
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
6.0%
3/50 • Number of events 3
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis, nasal congestion
|
8.9%
9/101 • Number of events 9
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
0.00%
0/50
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness, throat irritation, sore throat
|
6.9%
7/101 • Number of events 7
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
8.0%
4/50 • Number of events 4
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
|
Blood and lymphatic system disorders
Grade 1 leucopenia
|
28.7%
29/101 • Number of events 29
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
26.0%
13/50 • Number of events 13
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
|
Blood and lymphatic system disorders
Grade 2 leucopenia
|
44.6%
45/101 • Number of events 45
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
46.0%
23/50 • Number of events 23
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
|
Blood and lymphatic system disorders
Grade 3 leucopenia
|
19.8%
20/101 • Number of events 20
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
22.0%
11/50 • Number of events 11
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
|
Blood and lymphatic system disorders
Grade 1 neutropenia
|
10.9%
11/101 • Number of events 11
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
20.0%
10/50 • Number of events 10
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
|
Blood and lymphatic system disorders
Grade 2 neutropenia
|
35.6%
36/101 • Number of events 36
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
28.0%
14/50 • Number of events 14
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
|
Blood and lymphatic system disorders
Grade 3 neutropenia
|
28.7%
29/101 • Number of events 29
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
26.0%
13/50 • Number of events 13
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
|
Blood and lymphatic system disorders
Grade 4 neutropenia
|
2.0%
2/101 • Number of events 2
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
2.0%
1/50 • Number of events 1
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
|
Blood and lymphatic system disorders
Grade 1 lymphopenia
|
7.9%
8/101 • Number of events 8
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
18.0%
9/50 • Number of events 9
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
|
Blood and lymphatic system disorders
Grade 1 thrombocytopenia
|
46.5%
47/101 • Number of events 47
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
46.0%
23/50 • Number of events 23
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
|
Blood and lymphatic system disorders
Grade 2 thrombocytopenia
|
5.9%
6/101 • Number of events 6
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
4.0%
2/50 • Number of events 2
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
|
Blood and lymphatic system disorders
Grade 1 anemia
|
72.3%
73/101 • Number of events 73
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
66.0%
33/50 • Number of events 33
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
|
Blood and lymphatic system disorders
Grade 2 anemia
|
11.9%
12/101 • Number of events 12
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
16.0%
8/50 • Number of events 8
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
|
Endocrine disorders
Increased TTH level
|
11.9%
12/101 • Number of events 12
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
6.0%
3/50 • Number of events 3
The number of patients for the efficacy analysis was 150. 151 patients were included in the safety analysis, including 1 patient in Algeron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[severe depression at Visit 1\], who was not considered to be enrolled in the study due to serious protocol violation.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place