Trial Outcomes & Findings for A Phase III Clinical Study to Evaluate SYN023's Efficacy and Safety (NCT NCT04644484)
NCT ID: NCT04644484
Last Updated: 2023-04-21
Results Overview
Rabies Virus Neutralizing Activity (RVNA) was assessed using Rapid Fluorescent Focus Inhibition Test (RFFIT).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1000 participants
Primary outcome timeframe
Day 8
Results posted on
2023-04-21
Participant Flow
Participant milestones
| Measure |
Experimental Group: SYN023+Rabies Vaccine
1000 patients aged 18 and above with World Health Organization (WHO) Category III rabies exposure should be enrolled as planned and randomly assigned to the experimental group and the control group based on a ratio of 3:1 through on-site stratification as part of post-exposure prophylaxis (PEP).
SYN023: 0.3 mg/kg, wound infiltration injection. If the study drug isn't used up after infiltration injection for all wounds, the remaining amount should be injected into the muscles far away from the vaccine injection sites Frequency/duration: at Day 1
Rabies Vaccine: 0.5 milliliters (mL), intramuscular injection into the deltoid muscle Frequency/duration: at Day 1, 4, 8, 15, 29
|
Control Group: Human Rabies Immune Globulin (HRIG)+Rabie Vaccine
1000 patients aged 18 and above with World Health Organization (WHO) Category III rabies exposure should be enrolled as planned and randomly assigned to the experimental group and the control group based on a ratio of 3:1 through on-site stratification as part of post-exposure prophylaxis (PEP).
Human Rabies Immune Globulin (HRIG): 20 IU/kg, wound infiltration injection. If the study drug isn't used up after infiltration injection for all wounds, the remaining amount should be injected into the muscles far away from the vaccine injection sites Frequency/duration: at Day 1
Rabies Vaccine: 0.5 milliliters (mL), intramuscular injection into the deltoid muscle Frequency/duration: at Day 1, 4, 8, 15, 29
|
|---|---|---|
|
Overall Study
STARTED
|
750
|
250
|
|
Overall Study
COMPLETED
|
750
|
250
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase III Clinical Study to Evaluate SYN023's Efficacy and Safety
Baseline characteristics by cohort
| Measure |
Experimental Group: SYN023+Rabies Vaccine
n=750 Participants
1000 patients aged 18 and above with WHO Category III rabies exposure should be enrolled as planned and randomly assigned to the experimental group and the control group based on a ratio of 3:1 through on-site stratification as part of post-exposure prophylaxis (PEP).
SYN023: 0.3 mg/kg, wound infiltration injection. If the study drug isn't used up after infiltration injection for all wounds, the remaining amount should be injected into the muscles far away from the vaccine injection sites Frequency/duration: at Day 1
Rabies Vaccine: 0.5 milliliters (mL), intramuscular injection into the deltoid muscle Frequency/duration: at Day 1, 4, 8, 15, 29
|
Control Group: Human Rabies Immune Globulin (HRIG)+Rabie Vaccine
n=250 Participants
1000 patients aged 18 and above with WHO Category III rabies exposure should be enrolled as planned and randomly assigned to the experimental group and the control group based on a ratio of 3:1 through on-site stratification as part of post-exposure prophylaxis (PEP).
Human Rabies Immune Globulin (HRIG): 20 IU/kg, wound infiltration injection. If the study drug isn't used up after infiltration injection for all wounds, the remaining amount should be injected into the muscles far away from the vaccine injection sites Frequency/duration: at Day 1
Rabies Vaccine: 0.5 milliliters (mL), intramuscular injection into the deltoid muscle Frequency/duration: at Day 1, 4, 8, 15, 29
|
Total
n=1000 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.7 years
n=5 Participants
|
44.6 years
n=7 Participants
|
43.9 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
346 Participants
n=5 Participants
|
117 Participants
n=7 Participants
|
463 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
404 Participants
n=5 Participants
|
133 Participants
n=7 Participants
|
537 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
750 Participants
n=5 Participants
|
250 Participants
n=7 Participants
|
1000 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
BMI
|
23.39 kg/m^2
STANDARD_DEVIATION 3.489 • n=5 Participants
|
24.12 kg/m^2
STANDARD_DEVIATION 3.786 • n=7 Participants
|
23.57 kg/m^2
STANDARD_DEVIATION 3.578 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 8Population: The primary analysis set of the outcome measure data is Per-Protocol Analysis Set (PPS). The PPS included all subjects who were randomized, received the correct study drug, passed the confirmation of the inclusion/exclusion criteria \*, completed the rabies vaccination schedule as required by the protocol on Day 29 of the study, had no major protocol violations impacting efficacy evaluation, received adequate wound treatment of all exposed sites, and received study drug injection.
Rabies Virus Neutralizing Activity (RVNA) was assessed using Rapid Fluorescent Focus Inhibition Test (RFFIT).
Outcome measures
| Measure |
Experimental Group: SYN023+Rabies Vaccine
n=507 Participants
1000 patients aged 18 and above with WHO Category III rabies exposure should be enrolled as planned and randomly assigned to the experimental group and the control group based on a ratio of 3:1 through on-site stratification as part of post-exposure prophylaxis (PEP).
SYN023: 0.3 mg/kg, wound infiltration injection. If the study drug isn't used up after infiltration injection for all wounds, the remaining amount should be injected into the muscles far away from the vaccine injection sites Frequency/duration: at Day 1
Rabies Vaccine: 0.5 milliliters (mL), intramuscular injection into the deltoid muscle Frequency/duration: at Day 1, 4, 8, 15, 29
|
Control Group: Human Rabies Immune Globulin (HRIG)+Rabie Vaccine
n=165 Participants
1000 patients aged 18 and above with WHO Category III rabies exposure should be enrolled as planned and randomly assigned to the experimental group and the control group based on a ratio of 3:1 through on-site stratification as part of post-exposure prophylaxis (PEP).
Human Rabies Immune Globulin (HRIG): 20 IU/kg, wound infiltration injection. If the study drug isn't used up after infiltration injection for all wounds, the remaining amount should be injected into the muscles far away from the vaccine injection sites Frequency/duration: at Day 1
Rabies Vaccine: 0.5 milliliters (mL), intramuscular injection into the deltoid muscle Frequency/duration: at Day 1, 4, 8, 15, 29
|
|---|---|---|
|
Rabies Virus Neutralizing Activity (RVNA) of Geometric Mean Concentration (GMC) at Study Day 8
|
4.346 IU/mL
Interval 4.111 to 4.595
|
0.232 IU/mL
Interval 0.198 to 0.271
|
PRIMARY outcome
Timeframe: Day 1 to Day 365WHO's Classification of Rabies Cases: 1. Suspected case: refers to a case that satisfies the definition of clinical case; 2. Probable case: refers to a suspected case with a reliable medical history of contact with any suspected animal infected with the rabies virus; 3. Confirmed case: refers to a suspected or probable case that is proved to be infected based on the lab test result.
Outcome measures
| Measure |
Experimental Group: SYN023+Rabies Vaccine
n=750 Participants
1000 patients aged 18 and above with WHO Category III rabies exposure should be enrolled as planned and randomly assigned to the experimental group and the control group based on a ratio of 3:1 through on-site stratification as part of post-exposure prophylaxis (PEP).
SYN023: 0.3 mg/kg, wound infiltration injection. If the study drug isn't used up after infiltration injection for all wounds, the remaining amount should be injected into the muscles far away from the vaccine injection sites Frequency/duration: at Day 1
Rabies Vaccine: 0.5 milliliters (mL), intramuscular injection into the deltoid muscle Frequency/duration: at Day 1, 4, 8, 15, 29
|
Control Group: Human Rabies Immune Globulin (HRIG)+Rabie Vaccine
n=250 Participants
1000 patients aged 18 and above with WHO Category III rabies exposure should be enrolled as planned and randomly assigned to the experimental group and the control group based on a ratio of 3:1 through on-site stratification as part of post-exposure prophylaxis (PEP).
Human Rabies Immune Globulin (HRIG): 20 IU/kg, wound infiltration injection. If the study drug isn't used up after infiltration injection for all wounds, the remaining amount should be injected into the muscles far away from the vaccine injection sites Frequency/duration: at Day 1
Rabies Vaccine: 0.5 milliliters (mL), intramuscular injection into the deltoid muscle Frequency/duration: at Day 1, 4, 8, 15, 29
|
|---|---|---|
|
Number of Probable or Confirmed Rabies Cases
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Days 4, 15, 43, 99, 183 and 365Population: The analysis set of the outcome measure data is Per-Protocol Analysis Set (PPS). The PPS included all subjects who were randomized, received the correct study drug, passed the confirmation of the inclusion/exclusion criteria \*, completed the rabies vaccination schedule as required by the protocol on Day 29 of the study, had no major protocol violations impacting efficacy evaluation, received adequate wound treatment of all exposed sites, and received study drug injection.
Rabies Virus Neutralizing Activity (RVNA) was assessed using Rapid Fluorescent Focus Inhibition Test (RFFIT).
Outcome measures
| Measure |
Experimental Group: SYN023+Rabies Vaccine
n=507 Participants
1000 patients aged 18 and above with WHO Category III rabies exposure should be enrolled as planned and randomly assigned to the experimental group and the control group based on a ratio of 3:1 through on-site stratification as part of post-exposure prophylaxis (PEP).
SYN023: 0.3 mg/kg, wound infiltration injection. If the study drug isn't used up after infiltration injection for all wounds, the remaining amount should be injected into the muscles far away from the vaccine injection sites Frequency/duration: at Day 1
Rabies Vaccine: 0.5 milliliters (mL), intramuscular injection into the deltoid muscle Frequency/duration: at Day 1, 4, 8, 15, 29
|
Control Group: Human Rabies Immune Globulin (HRIG)+Rabie Vaccine
n=165 Participants
1000 patients aged 18 and above with WHO Category III rabies exposure should be enrolled as planned and randomly assigned to the experimental group and the control group based on a ratio of 3:1 through on-site stratification as part of post-exposure prophylaxis (PEP).
Human Rabies Immune Globulin (HRIG): 20 IU/kg, wound infiltration injection. If the study drug isn't used up after infiltration injection for all wounds, the remaining amount should be injected into the muscles far away from the vaccine injection sites Frequency/duration: at Day 1
Rabies Vaccine: 0.5 milliliters (mL), intramuscular injection into the deltoid muscle Frequency/duration: at Day 1, 4, 8, 15, 29
|
|---|---|---|
|
Rabies Virus Neutralizing Activity (RVNA) of Geometric Mean Concentration (GMC)
Day 4
|
4.212 IU/mL
Interval 3.962 to 4.479
|
0.193 IU/mL
Interval 0.172 to 0.216
|
|
Rabies Virus Neutralizing Activity (RVNA) of Geometric Mean Concentration (GMC)
Day 15
|
13.590 IU/mL
Interval 12.624 to 14.63
|
7.651 IU/mL
Interval 6.241 to 9.38
|
|
Rabies Virus Neutralizing Activity (RVNA) of Geometric Mean Concentration (GMC)
Day 43
|
13.084 IU/mL
Interval 12.238 to 13.989
|
16.003 IU/mL
Interval 13.65 to 18.762
|
|
Rabies Virus Neutralizing Activity (RVNA) of Geometric Mean Concentration (GMC)
Day 99
|
2.023 IU/mL
Interval 1.869 to 2.19
|
5.108 IU/mL
Interval 4.109 to 6.351
|
|
Rabies Virus Neutralizing Activity (RVNA) of Geometric Mean Concentration (GMC)
Day 183
|
0.891 IU/mL
Interval 0.812 to 0.978
|
3.319 IU/mL
Interval 2.681 to 4.108
|
|
Rabies Virus Neutralizing Activity (RVNA) of Geometric Mean Concentration (GMC)
Day 365
|
0.520 IU/mL
Interval 0.473 to 0.572
|
1.645 IU/mL
Interval 1.343 to 2.014
|
SECONDARY outcome
Timeframe: Days 4, 8, 15, 43, 99, 183 and 365Population: The analysis set of the outcome measure data is Per-Protocol Analysis Set (PPS). The PPS included all subjects who were randomized, received the correct study drug, passed the confirmation of the inclusion/exclusion criteria \*, completed the rabies vaccination schedule as required by the protocol on Day 29 of the study, had no major protocol violations impacting efficacy evaluation, received adequate wound treatment of all exposed sites, and received study drug injection.
Rabies Virus Neutralizing Activity (RVNA) was assessed using Rapid Fluorescent Focus Inhibition Test (RFFIT).
Outcome measures
| Measure |
Experimental Group: SYN023+Rabies Vaccine
n=507 Participants
1000 patients aged 18 and above with WHO Category III rabies exposure should be enrolled as planned and randomly assigned to the experimental group and the control group based on a ratio of 3:1 through on-site stratification as part of post-exposure prophylaxis (PEP).
SYN023: 0.3 mg/kg, wound infiltration injection. If the study drug isn't used up after infiltration injection for all wounds, the remaining amount should be injected into the muscles far away from the vaccine injection sites Frequency/duration: at Day 1
Rabies Vaccine: 0.5 milliliters (mL), intramuscular injection into the deltoid muscle Frequency/duration: at Day 1, 4, 8, 15, 29
|
Control Group: Human Rabies Immune Globulin (HRIG)+Rabie Vaccine
n=165 Participants
1000 patients aged 18 and above with WHO Category III rabies exposure should be enrolled as planned and randomly assigned to the experimental group and the control group based on a ratio of 3:1 through on-site stratification as part of post-exposure prophylaxis (PEP).
Human Rabies Immune Globulin (HRIG): 20 IU/kg, wound infiltration injection. If the study drug isn't used up after infiltration injection for all wounds, the remaining amount should be injected into the muscles far away from the vaccine injection sites Frequency/duration: at Day 1
Rabies Vaccine: 0.5 milliliters (mL), intramuscular injection into the deltoid muscle Frequency/duration: at Day 1, 4, 8, 15, 29
|
|---|---|---|
|
Percentage of Participants With Rabies Virus Neutralizing Activity (RVNA) ≥0.5 IU/mL
Day 4
|
99.8 percentage of participants(%)
Interval 98.906 to 99.995
|
9.1 percentage of participants(%)
Interval 5.178 to 14.551
|
|
Percentage of Participants With Rabies Virus Neutralizing Activity (RVNA) ≥0.5 IU/mL
Day 8
|
99.6 percentage of participants(%)
Interval 98.582 to 99.952
|
17.6 percentage of participants(%)
Interval 12.098 to 24.256
|
|
Percentage of Participants With Rabies Virus Neutralizing Activity (RVNA) ≥0.5 IU/mL
Day 15
|
100 percentage of participants(%)
Interval 99.275 to 100.0
|
96.4 percentage of participants(%)
Interval 92.253 to 98.654
|
|
Percentage of Participants With Rabies Virus Neutralizing Activity (RVNA) ≥0.5 IU/mL
Day 43
|
100 percentage of participants(%)
Interval 98.269 to 100.0
|
99.4 percentage of participants(%)
Interval 96.67 to 99.985
|
|
Percentage of Participants With Rabies Virus Neutralizing Activity (RVNA) ≥0.5 IU/mL
Day 99
|
97.8 percentage of participants(%)
Interval 96.059 to 98.886
|
97.5 percentage of participants(%)
Interval 93.761 to 99.319
|
|
Percentage of Participants With Rabies Virus Neutralizing Activity (RVNA) ≥0.5 IU/mL
Day 183
|
72.8 percentage of participants(%)
Interval 68.636 to 76.654
|
95.6 percentage of participants(%)
Interval 91.194 to 98.223
|
|
Percentage of Participants With Rabies Virus Neutralizing Activity (RVNA) ≥0.5 IU/mL
Day 365
|
47.2 percentage of participants(%)
Interval 42.678 to 51.766
|
81.9 percentage of participants(%)
Interval 75.018 to 87.513
|
SECONDARY outcome
Timeframe: Day 1 to Day 15Population: The Per Protocol Set (PPS) included all subjects who were randomized, received the correct study drug, passed the confirmation of the inclusion/exclusion criteria \*, completed the rabies vaccination schedule as required by the protocol on Day 29 of the study, had no major protocol violations impacting efficacy evaluation, received adequate wound treatment of all exposed sites, and received study drug injection.
Rabies Virus Neutralizing Activity (RVNA) was assessed using Rapid Fluorescent Focus Inhibition Test (RFFIT). Area Under the Efficacy Curve for the GMC of RVNA from Study Day 1 to Day 15 after administration (AUEC1-15)
Outcome measures
| Measure |
Experimental Group: SYN023+Rabies Vaccine
n=507 Participants
1000 patients aged 18 and above with WHO Category III rabies exposure should be enrolled as planned and randomly assigned to the experimental group and the control group based on a ratio of 3:1 through on-site stratification as part of post-exposure prophylaxis (PEP).
SYN023: 0.3 mg/kg, wound infiltration injection. If the study drug isn't used up after infiltration injection for all wounds, the remaining amount should be injected into the muscles far away from the vaccine injection sites Frequency/duration: at Day 1
Rabies Vaccine: 0.5 milliliters (mL), intramuscular injection into the deltoid muscle Frequency/duration: at Day 1, 4, 8, 15, 29
|
Control Group: Human Rabies Immune Globulin (HRIG)+Rabie Vaccine
n=165 Participants
1000 patients aged 18 and above with WHO Category III rabies exposure should be enrolled as planned and randomly assigned to the experimental group and the control group based on a ratio of 3:1 through on-site stratification as part of post-exposure prophylaxis (PEP).
Human Rabies Immune Globulin (HRIG): 20 IU/kg, wound infiltration injection. If the study drug isn't used up after infiltration injection for all wounds, the remaining amount should be injected into the muscles far away from the vaccine injection sites Frequency/duration: at Day 1
Rabies Vaccine: 0.5 milliliters (mL), intramuscular injection into the deltoid muscle Frequency/duration: at Day 1, 4, 8, 15, 29
|
|---|---|---|
|
Area Under the Efficacy Curve for the Geometric Mean Concentration (GMC) of Rabies Virus Neutralizing Activity (RVNA)
|
96.972 days *IU/mL
Interval 91.955 to 102.263
|
31.869 days *IU/mL
Interval 26.563 to 38.233
|
Adverse Events
Experimental Group: SYN023+Rabies Vaccine
Serious events: 41 serious events
Other events: 315 other events
Deaths: 0 deaths
Control Group: HRIG+Rabie Vaccine
Serious events: 14 serious events
Other events: 138 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Experimental Group: SYN023+Rabies Vaccine
n=750 participants at risk
1000 patients aged 18 and above with WHO Category III rabies exposure should be enrolled as planned and randomly assigned to the experimental group and the control group based on a ratio of 3:1 through on-site stratification as part of PEP.
SYN023: 0.3 mg/kg, wound infiltration injection. If the study drug isn't used up after infiltration injection for all wounds, the remaining amount should be injected into the muscles far away from the vaccine injection sites Frequency/duration: at Day 1
Rabies Vaccine: 0.5 mL, intramuscular injection into the deltoid muscle Frequency/duration: at Day 1, 4, 8, 15, 29
|
Control Group: HRIG+Rabie Vaccine
n=250 participants at risk
1000 patients aged 18 and above with WHO Category III rabies exposure should be enrolled as planned and randomly assigned to the experimental group and the control group based on a ratio of 3:1 through on-site stratification as part of PEP.
HRIG: 20 IU/kg, wound infiltration injection. If the study drug isn't used up after infiltration injection for all wounds, the remaining amount should be injected into the muscles far away from the vaccine injection sites Frequency/duration: at Day 1
Rabies Vaccine: 0.5 mL, intramuscular injection into the deltoid muscle Frequency/duration: at Day 1, 4, 8, 15, 29
|
|---|---|---|
|
Infections and infestations
Infectious pneumonitis
|
0.53%
4/750 • Number of events 4 • 365 days
|
0.80%
2/250 • Number of events 2 • 365 days
|
|
Infections and infestations
Herpes zoster
|
0.27%
2/750 • Number of events 2 • 365 days
|
0.40%
1/250 • Number of events 1 • 365 days
|
|
Infections and infestations
Bronchitis
|
0.13%
1/750 • Number of events 1 • 365 days
|
0.80%
2/250 • Number of events 2 • 365 days
|
|
Infections and infestations
Bacterial pneumonia
|
0.27%
2/750 • Number of events 2 • 365 days
|
0.00%
0/250 • 365 days
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.13%
1/750 • Number of events 1 • 365 days
|
0.00%
0/250 • 365 days
|
|
Infections and infestations
Sinusitis
|
0.13%
1/750 • Number of events 1 • 365 days
|
0.00%
0/250 • 365 days
|
|
Infections and infestations
Infectious mononucleosis
|
0.13%
1/750 • Number of events 1 • 365 days
|
0.00%
0/250 • 365 days
|
|
Infections and infestations
Scrub typhus
|
0.00%
0/750 • 365 days
|
0.40%
1/250 • Number of events 2 • 365 days
|
|
Infections and infestations
Cellulitis
|
0.13%
1/750 • Number of events 1 • 365 days
|
0.00%
0/250 • 365 days
|
|
Infections and infestations
Anal abscess
|
0.13%
1/750 • Number of events 1 • 365 days
|
0.00%
0/250 • 365 days
|
|
Infections and infestations
Gingivitis
|
0.13%
1/750 • Number of events 1 • 365 days
|
0.00%
0/250 • 365 days
|
|
Infections and infestations
Appendicitis
|
0.13%
1/750 • Number of events 1 • 365 days
|
0.00%
0/250 • 365 days
|
|
Infections and infestations
Urethritis
|
0.13%
1/750 • Number of events 1 • 365 days
|
0.00%
0/250 • 365 days
|
|
Infections and infestations
Pelvic inflammatory disease
|
0.13%
1/750 • Number of events 1 • 365 days
|
0.00%
0/250 • 365 days
|
|
Infections and infestations
Soft tissue infection
|
0.13%
1/750 • Number of events 1 • 365 days
|
0.00%
0/250 • 365 days
|
|
Infections and infestations
Upper respiratory tract infection
|
0.13%
1/750 • Number of events 2 • 365 days
|
0.00%
0/250 • 365 days
|
|
Infections and infestations
Ureteritis
|
0.13%
1/750 • Number of events 1 • 365 days
|
0.00%
0/250 • 365 days
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.13%
1/750 • Number of events 1 • 365 days
|
0.00%
0/250 • 365 days
|
|
Infections and infestations
Gastroenteritis
|
0.13%
1/750 • Number of events 1 • 365 days
|
0.00%
0/250 • 365 days
|
|
Infections and infestations
Infected bite
|
0.13%
1/750 • Number of events 1 • 365 days
|
0.00%
0/250 • 365 days
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.27%
2/750 • Number of events 2 • 365 days
|
0.40%
1/250 • Number of events 1 • 365 days
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.27%
2/750 • Number of events 3 • 365 days
|
0.40%
1/250 • Number of events 1 • 365 days
|
|
Gastrointestinal disorders
Gastritis
|
0.27%
2/750 • Number of events 2 • 365 days
|
0.00%
0/250 • 365 days
|
|
Gastrointestinal disorders
Hypertrophic anal papilla
|
0.13%
1/750 • Number of events 1 • 365 days
|
0.00%
0/250 • 365 days
|
|
Gastrointestinal disorders
Duodenitis
|
0.13%
1/750 • Number of events 1 • 365 days
|
0.00%
0/250 • 365 days
|
|
Gastrointestinal disorders
Oesophagitis
|
0.13%
1/750 • Number of events 1 • 365 days
|
0.00%
0/250 • 365 days
|
|
Gastrointestinal disorders
Gastric polyps
|
0.00%
0/750 • 365 days
|
0.40%
1/250 • Number of events 1 • 365 days
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.13%
1/750 • Number of events 1 • 365 days
|
0.00%
0/250 • 365 days
|
|
Injury, poisoning and procedural complications
Contusions
|
0.13%
1/750 • Number of events 1 • 365 days
|
0.00%
0/250 • 365 days
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.13%
1/750 • Number of events 2 • 365 days
|
0.00%
0/250 • 365 days
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.13%
1/750 • Number of events 1 • 365 days
|
0.00%
0/250 • 365 days
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.13%
1/750 • Number of events 1 • 365 days
|
0.00%
0/250 • 365 days
|
|
Injury, poisoning and procedural complications
Craniocerebral Trauma
|
0.00%
0/750 • 365 days
|
0.40%
1/250 • Number of events 1 • 365 days
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.13%
1/750 • Number of events 1 • 365 days
|
0.00%
0/250 • 365 days
|
|
Injury, poisoning and procedural complications
Brain herniation
|
0.13%
1/750 • Number of events 1 • 365 days
|
0.00%
0/250 • 365 days
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.13%
1/750 • Number of events 1 • 365 days
|
0.00%
0/250 • 365 days
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/750 • 365 days
|
0.40%
1/250 • Number of events 1 • 365 days
|
|
Injury, poisoning and procedural complications
Snake bite
|
0.00%
0/750 • 365 days
|
0.40%
1/250 • Number of events 1 • 365 days
|
|
Injury, poisoning and procedural complications
Extradural haematoma
|
0.13%
1/750 • Number of events 1 • 365 days
|
0.00%
0/250 • 365 days
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.13%
1/750 • Number of events 1 • 365 days
|
0.00%
0/250 • 365 days
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/750 • 365 days
|
0.40%
1/250 • Number of events 1 • 365 days
|
|
Nervous system disorders
Cerebral hemorrhage
|
0.13%
1/750 • Number of events 1 • 365 days
|
0.00%
0/250 • 365 days
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.13%
1/750 • Number of events 1 • 365 days
|
0.00%
0/250 • 365 days
|
|
Nervous system disorders
Cerebral hypoperfusion
|
0.13%
1/750 • Number of events 1 • 365 days
|
0.00%
0/250 • 365 days
|
|
Nervous system disorders
Radiculopathy
|
0.13%
1/750 • Number of events 1 • 365 days
|
0.00%
0/250 • 365 days
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.13%
1/750 • Number of events 1 • 365 days
|
0.00%
0/250 • 365 days
|
|
Nervous system disorders
Ischial neuralgia
|
0.00%
0/750 • 365 days
|
0.40%
1/250 • Number of events 1 • 365 days
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.27%
2/750 • Number of events 2 • 365 days
|
0.40%
1/250 • Number of events 1 • 365 days
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.13%
1/750 • Number of events 1 • 365 days
|
0.40%
1/250 • Number of events 1 • 365 days
|
|
Musculoskeletal and connective tissue disorders
Vertebral end plate inflammation
|
0.00%
0/750 • 365 days
|
0.40%
1/250 • Number of events 1 • 365 days
|
|
Musculoskeletal and connective tissue disorders
Osteoarthrosis
|
0.00%
0/750 • 365 days
|
0.40%
1/250 • Number of events 1 • 365 days
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
0.13%
1/750 • Number of events 1 • 365 days
|
0.00%
0/250 • 365 days
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis stenosans
|
0.13%
1/750 • Number of events 1 • 365 days
|
0.00%
0/250 • 365 days
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/750 • 365 days
|
0.40%
1/250 • Number of events 1 • 365 days
|
|
Renal and urinary disorders
Ureteral calculus
|
0.53%
4/750 • Number of events 4 • 365 days
|
0.00%
0/250 • 365 days
|
|
Renal and urinary disorders
Renal hydrocele
|
0.40%
3/750 • Number of events 3 • 365 days
|
0.00%
0/250 • 365 days
|
|
Renal and urinary disorders
Nephrolith
|
0.40%
3/750 • Number of events 3 • 365 days
|
0.00%
0/250 • 365 days
|
|
Renal and urinary disorders
Renal Colic
|
0.27%
2/750 • Number of events 2 • 365 days
|
0.00%
0/250 • 365 days
|
|
Renal and urinary disorders
Hydroureter
|
0.13%
1/750 • Number of events 1 • 365 days
|
0.00%
0/250 • 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.13%
1/750 • Number of events 1 • 365 days
|
0.00%
0/250 • 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary disease
|
0.00%
0/750 • 365 days
|
0.40%
1/250 • Number of events 1 • 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough variant asthma
|
0.13%
1/750 • Number of events 1 • 365 days
|
0.00%
0/250 • 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.13%
1/750 • Number of events 2 • 365 days
|
0.00%
0/250 • 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal aspiration
|
0.13%
1/750 • Number of events 1 • 365 days
|
0.00%
0/250 • 365 days
|
|
Respiratory, thoracic and mediastinal disorders
pleurisy
|
0.13%
1/750 • Number of events 1 • 365 days
|
0.00%
0/250 • 365 days
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.13%
1/750 • Number of events 1 • 365 days
|
0.00%
0/250 • 365 days
|
|
Metabolism and nutrition disorders
Gout
|
0.13%
1/750 • Number of events 1 • 365 days
|
0.00%
0/250 • 365 days
|
|
Metabolism and nutrition disorders
Neonatal hypoglycaemia
|
0.13%
1/750 • Number of events 1 • 365 days
|
0.00%
0/250 • 365 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pleomorphic adenoma
|
0.13%
1/750 • Number of events 1 • 365 days
|
0.00%
0/250 • 365 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma lung stage I
|
0.00%
0/750 • 365 days
|
0.40%
1/250 • Number of events 1 • 365 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour of the gastrointestinal tract
|
0.13%
1/750 • Number of events 1 • 365 days
|
0.00%
0/250 • 365 days
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/750 • 365 days
|
0.40%
1/250 • Number of events 1 • 365 days
|
|
Hepatobiliary disorders
cholelithiasis
|
0.00%
0/750 • 365 days
|
0.40%
1/250 • Number of events 1 • 365 days
|
|
Hepatobiliary disorders
Hyperbilirubinaemia newborn
|
0.13%
1/750 • Number of events 1 • 365 days
|
0.00%
0/250 • 365 days
|
|
Pregnancy, puerperium and perinatal conditions
Shoulder dystocia
|
0.13%
1/750 • Number of events 1 • 365 days
|
0.00%
0/250 • 365 days
|
|
Pregnancy, puerperium and perinatal conditions
Gestational hypertension
|
0.00%
0/750 • 365 days
|
0.40%
1/250 • Number of events 1 • 365 days
|
|
Pregnancy, puerperium and perinatal conditions
Pre-eclampsia
|
0.00%
0/750 • 365 days
|
0.40%
1/250 • Number of events 1 • 365 days
|
|
Immune system disorders
hypersensitivity reaction
|
0.13%
1/750 • Number of events 1 • 365 days
|
0.00%
0/250 • 365 days
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/750 • 365 days
|
0.40%
1/250 • Number of events 1 • 365 days
|
|
Skin and subcutaneous tissue disorders
Allergic dermatitis
|
0.13%
1/750 • Number of events 1 • 365 days
|
0.00%
0/250 • 365 days
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.13%
1/750 • Number of events 1 • 365 days
|
0.00%
0/250 • 365 days
|
|
Cardiac disorders
Aortic valve disease mixed
|
0.13%
1/750 • Number of events 1 • 365 days
|
0.00%
0/250 • 365 days
|
|
Vascular disorders
Vein varicose
|
0.00%
0/750 • 365 days
|
0.40%
1/250 • Number of events 3 • 365 days
|
Other adverse events
| Measure |
Experimental Group: SYN023+Rabies Vaccine
n=750 participants at risk
1000 patients aged 18 and above with WHO Category III rabies exposure should be enrolled as planned and randomly assigned to the experimental group and the control group based on a ratio of 3:1 through on-site stratification as part of PEP.
SYN023: 0.3 mg/kg, wound infiltration injection. If the study drug isn't used up after infiltration injection for all wounds, the remaining amount should be injected into the muscles far away from the vaccine injection sites Frequency/duration: at Day 1
Rabies Vaccine: 0.5 mL, intramuscular injection into the deltoid muscle Frequency/duration: at Day 1, 4, 8, 15, 29
|
Control Group: HRIG+Rabie Vaccine
n=250 participants at risk
1000 patients aged 18 and above with WHO Category III rabies exposure should be enrolled as planned and randomly assigned to the experimental group and the control group based on a ratio of 3:1 through on-site stratification as part of PEP.
HRIG: 20 IU/kg, wound infiltration injection. If the study drug isn't used up after infiltration injection for all wounds, the remaining amount should be injected into the muscles far away from the vaccine injection sites Frequency/duration: at Day 1
Rabies Vaccine: 0.5 mL, intramuscular injection into the deltoid muscle Frequency/duration: at Day 1, 4, 8, 15, 29
|
|---|---|---|
|
General disorders
Administration site swelling
|
17.1%
128/750 • 365 days
|
34.8%
87/250 • 365 days
|
|
General disorders
Administration site pain
|
4.8%
36/750 • 365 days
|
8.0%
20/250 • 365 days
|
|
General disorders
Administration site erythema
|
4.3%
32/750 • 365 days
|
6.0%
15/250 • 365 days
|
|
General disorders
Administration site pruritus
|
0.93%
7/750 • 365 days
|
2.4%
6/250 • 365 days
|
|
General disorders
Administration site haemorrhage
|
0.80%
6/750 • 365 days
|
0.00%
0/250 • 365 days
|
|
General disorders
Administration site paraesthesia
|
0.13%
1/750 • 365 days
|
0.40%
1/250 • 365 days
|
|
General disorders
Vaccination site pain
|
3.6%
27/750 • 365 days
|
4.8%
12/250 • 365 days
|
|
General disorders
Vaccination site Pruritus
|
0.27%
2/750 • 365 days
|
1.2%
3/250 • 365 days
|
|
General disorders
Vaccination site discomfort
|
0.13%
1/750 • 365 days
|
0.00%
0/250 • 365 days
|
|
General disorders
Vaccination site rash
|
0.00%
0/750 • 365 days
|
0.40%
1/250 • 365 days
|
|
General disorders
Vaccination site swelling
|
0.00%
0/750 • 365 days
|
0.40%
1/250 • 365 days
|
|
General disorders
Peripheral swelling
|
0.13%
1/750 • 365 days
|
0.00%
0/250 • 365 days
|
|
General disorders
Fever
|
2.3%
17/750 • 365 days
|
2.8%
7/250 • 365 days
|
|
General disorders
Asthenia
|
0.53%
4/750 • 365 days
|
1.2%
3/250 • 365 days
|
|
General disorders
Chills
|
0.40%
3/750 • 365 days
|
0.80%
2/250 • 365 days
|
|
General disorders
Chest pain
|
0.13%
1/750 • 365 days
|
0.00%
0/250 • 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.1%
23/750 • 365 days
|
3.2%
8/250 • 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.2%
9/750 • 365 days
|
2.4%
6/250 • 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Running nose
|
1.2%
9/750 • 365 days
|
2.0%
5/250 • 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Dry Throat
|
0.00%
0/750 • 365 days
|
1.2%
3/250 • 365 days
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion.
|
0.13%
1/750 • 365 days
|
0.40%
1/250 • 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary disease
|
0.13%
1/750 • 365 days
|
0.00%
0/250 • 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.13%
1/750 • 365 days
|
0.00%
0/250 • 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory alkalosis
|
0.13%
1/750 • 365 days
|
0.00%
0/250 • 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
0.13%
1/750 • 365 days
|
0.00%
0/250 • 365 days
|
|
Nervous system disorders
Headache
|
4.0%
30/750 • 365 days
|
4.8%
12/250 • 365 days
|
|
Nervous system disorders
Dizziness
|
1.6%
12/750 • 365 days
|
1.6%
4/250 • 365 days
|
|
Nervous system disorders
Hypaesthesia
|
0.13%
1/750 • 365 days
|
0.00%
0/250 • 365 days
|
|
Infections and infestations
Upper respiratory tract infection
|
1.5%
11/750 • 365 days
|
2.4%
6/250 • 365 days
|
|
Infections and infestations
Nasopharyngitis
|
1.2%
9/750 • 365 days
|
0.40%
1/250 • 365 days
|
|
Infections and infestations
Infected bite
|
0.27%
2/750 • 365 days
|
0.40%
1/250 • 365 days
|
|
Infections and infestations
Gastroenteritis
|
0.27%
2/750 • 365 days
|
0.00%
0/250 • 365 days
|
|
Infections and infestations
Pericoronitis
|
0.13%
1/750 • 365 days
|
0.00%
0/250 • 365 days
|
|
Infections and infestations
Folliculitis
|
0.13%
1/750 • 365 days
|
0.00%
0/250 • 365 days
|
|
Infections and infestations
Herpes virus infection
|
0.13%
1/750 • 365 days
|
0.00%
0/250 • 365 days
|
|
Infections and infestations
Parotitis
|
0.13%
1/750 • 365 days
|
0.00%
0/250 • 365 days
|
|
Infections and infestations
Wound infection
|
0.13%
1/750 • 365 days
|
0.00%
0/250 • 365 days
|
|
Gastrointestinal disorders
Diarrhea
|
0.67%
5/750 • 365 days
|
1.6%
4/250 • 365 days
|
|
Gastrointestinal disorders
Nausea
|
0.40%
3/750 • 365 days
|
1.2%
3/250 • 365 days
|
|
Gastrointestinal disorders
Toothache
|
0.67%
5/750 • 365 days
|
0.40%
1/250 • 365 days
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.27%
2/750 • 365 days
|
0.40%
1/250 • 365 days
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.27%
2/750 • 365 days
|
1.2%
3/250 • 365 days
|
|
Gastrointestinal disorders
Bloating
|
0.53%
4/750 • 365 days
|
0.00%
0/250 • 365 days
|
|
Gastrointestinal disorders
Abdominal pain
|
0.13%
1/750 • 365 days
|
0.80%
2/250 • 365 days
|
|
Gastrointestinal disorders
Epigastric pain
|
0.13%
1/750 • 365 days
|
0.80%
2/250 • 365 days
|
|
Gastrointestinal disorders
Noninfective gingivitis
|
0.27%
2/750 • 365 days
|
0.00%
0/250 • 365 days
|
|
Gastrointestinal disorders
Dry mouth
|
0.27%
2/750 • 365 days
|
0.00%
0/250 • 365 days
|
|
Gastrointestinal disorders
Dental caries
|
0.13%
1/750 • 365 days
|
0.40%
1/250 • 365 days
|
|
Gastrointestinal disorders
Oesophagitis
|
0.13%
1/750 • 365 days
|
0.00%
0/250 • 365 days
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.13%
1/750 • 365 days
|
0.00%
0/250 • 365 days
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.13%
1/750 • 365 days
|
0.00%
0/250 • 365 days
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/750 • 365 days
|
0.40%
1/250 • 365 days
|
|
Gastrointestinal disorders
Dental paraesthesia
|
0.00%
0/750 • 365 days
|
0.40%
1/250 • 365 days
|
|
Gastrointestinal disorders
Gingival swelling
|
0.00%
0/750 • 365 days
|
0.40%
1/250 • 365 days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.1%
8/750 • 365 days
|
0.80%
2/250 • 365 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.80%
6/750 • 365 days
|
0.40%
1/250 • 365 days
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.53%
4/750 • 365 days
|
0.80%
2/250 • 365 days
|
|
Musculoskeletal and connective tissue disorders
Limb pain
|
0.53%
4/750 • 365 days
|
0.40%
1/250 • 365 days
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.13%
1/750 • 365 days
|
0.00%
0/250 • 365 days
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.13%
1/750 • 365 days
|
0.80%
2/250 • 365 days
|
|
Musculoskeletal and connective tissue disorders
Vertebral wedging
|
0.13%
1/750 • 365 days
|
0.00%
0/250 • 365 days
|
|
Musculoskeletal and connective tissue disorders
Bone hypertrophy
|
0.13%
1/750 • 365 days
|
0.00%
0/250 • 365 days
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/750 • 365 days
|
0.40%
1/250 • 365 days
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.13%
1/750 • 365 days
|
0.00%
0/250 • 365 days
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.13%
1/750 • 365 days
|
0.00%
0/250 • 365 days
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.40%
3/750 • 365 days
|
0.40%
1/250 • 365 days
|
|
Injury, poisoning and procedural complications
Animal scratches
|
0.13%
1/750 • 365 days
|
0.40%
1/250 • 365 days
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.13%
1/750 • 365 days
|
0.00%
0/250 • 365 days
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.13%
1/750 • 365 days
|
0.00%
0/250 • 365 days
|
|
Injury, poisoning and procedural complications
Subcutaneous hematoma
|
0.13%
1/750 • 365 days
|
0.00%
0/250 • 365 days
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
0.13%
1/750 • 365 days
|
0.00%
0/250 • 365 days
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.13%
1/750 • 365 days
|
0.00%
0/250 • 365 days
|
|
Injury, poisoning and procedural complications
Inflammation of wound
|
0.13%
1/750 • 365 days
|
0.00%
0/250 • 365 days
|
|
Injury, poisoning and procedural complications
Injection related reaction
|
0.13%
1/750 • 365 days
|
0.00%
0/250 • 365 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.2%
9/750 • 365 days
|
0.80%
2/250 • 365 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.67%
5/750 • 365 days
|
0.00%
0/250 • 365 days
|
|
Skin and subcutaneous tissue disorders
Allergic dermatitis
|
0.27%
2/750 • 365 days
|
0.00%
0/250 • 365 days
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.13%
1/750 • 365 days
|
0.00%
0/250 • 365 days
|
|
Skin and subcutaneous tissue disorders
Urticarial rash
|
0.00%
0/750 • 365 days
|
0.40%
1/250 • 365 days
|
|
Vascular disorders
Hypertension
|
0.80%
6/750 • 365 days
|
0.80%
2/250 • 365 days
|
|
Vascular disorders
Pallor
|
0.00%
0/750 • 365 days
|
0.40%
1/250 • 365 days
|
|
Vascular disorders
Shock
|
0.13%
1/750 • 365 days
|
0.00%
0/250 • 365 days
|
|
Vascular disorders
Aortic dilatation
|
0.13%
1/750 • 365 days
|
0.00%
0/250 • 365 days
|
|
Renal and urinary disorders
Nephrolith
|
0.13%
1/750 • 365 days
|
0.00%
0/250 • 365 days
|
|
Renal and urinary disorders
Renal cyst
|
0.13%
1/750 • 365 days
|
0.40%
1/250 • 365 days
|
|
Renal and urinary disorders
Urgency urination
|
0.13%
1/750 • 365 days
|
0.00%
0/250 • 365 days
|
|
Renal and urinary disorders
Frequent Micturition
|
0.13%
1/750 • 365 days
|
0.00%
0/250 • 365 days
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.27%
2/750 • 365 days
|
0.40%
1/250 • 365 days
|
|
Metabolism and nutrition disorders
Gout
|
0.13%
1/750 • 365 days
|
0.00%
0/250 • 365 days
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.13%
1/750 • 365 days
|
0.00%
0/250 • 365 days
|
|
Investigations
Blood pressure increased
|
0.27%
2/750 • 365 days
|
0.00%
0/250 • 365 days
|
|
Investigations
Spinal X-ray abnormal
|
0.13%
1/750 • 365 days
|
0.00%
0/250 • 365 days
|
|
Investigations
Ultrasound prostate abnormal
|
0.13%
1/750 • 365 days
|
0.00%
0/250 • 365 days
|
|
Investigations
Blood zinc abnormal
|
0.00%
0/750 • 365 days
|
0.40%
1/250 • 365 days
|
|
Reproductive system and breast disorders
Breast hyperplasia
|
0.27%
2/750 • 365 days
|
0.00%
0/250 • 365 days
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.13%
1/750 • 365 days
|
0.00%
0/250 • 365 days
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.13%
1/750 • 365 days
|
0.00%
0/250 • 365 days
|
|
Reproductive system and breast disorders
Hypomenorrhoea
|
0.13%
1/750 • 365 days
|
0.00%
0/250 • 365 days
|
|
Hepatobiliary disorders
Gallbladder polyp
|
0.27%
2/750 • 365 days
|
0.00%
0/250 • 365 days
|
|
Hepatobiliary disorders
Fatty degeneration of liver
|
0.13%
1/750 • 365 days
|
0.00%
0/250 • 365 days
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/750 • 365 days
|
0.40%
1/250 • 365 days
|
|
Cardiac disorders
Atrial enlargement
|
0.13%
1/750 • 365 days
|
0.00%
0/250 • 365 days
|
|
Cardiac disorders
Palpitation
|
0.13%
1/750 • 365 days
|
0.00%
0/250 • 365 days
|
|
Psychiatric disorders
Insomnia
|
0.13%
1/750 • 365 days
|
0.00%
0/250 • 365 days
|
|
Psychiatric disorders
Poor quality sleep
|
0.13%
1/750 • 365 days
|
0.00%
0/250 • 365 days
|
|
Psychiatric disorders
Fear of injection
|
0.13%
1/750 • 365 days
|
0.00%
0/250 • 365 days
|
|
Eye disorders
Dry eyes
|
0.00%
0/750 • 365 days
|
0.40%
1/250 • 365 days
|
|
Eye disorders
Hyperaemia of conjunctiva
|
0.13%
1/750 • 365 days
|
0.00%
0/250 • 365 days
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/750 • 365 days
|
0.40%
1/250 • 365 days
|
|
Surgical and medical procedures
Tracheal operation
|
0.13%
1/750 • 365 days
|
0.00%
0/250 • 365 days
|
|
Congenital, familial and genetic disorders
Accessory breast
|
0.13%
1/750 • 365 days
|
0.00%
0/250 • 365 days
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.00%
0/750 • 365 days
|
0.40%
1/250 • 365 days
|
|
Blood and lymphatic system disorders
Anemia
|
0.13%
1/750 • 365 days
|
0.00%
0/250 • 365 days
|
Additional Information
Director of Clinical Trials
Synermore Biologics Co., Ltd.
Phone: +86-512-87658266
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place