Trial Outcomes & Findings for Study to Compare the Efficacy and Safety of Passive Immunization With TNM002 Injection and Human Tetanus Immunoglobulin as Prophylaxis Against Tetanus (NCT NCT05664750)
NCT ID: NCT05664750
Last Updated: 2026-09-01
Results Overview
The change of anti-tetanus neutralizing antibody titers from baseline were defined as ΔTiters, calculated as the post-administration antibody titers minus the baseline antibody titers. The antibody protective level is ΔTiters ≥0.01 IU/mL.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
675 participants
Primary outcome timeframe
Baseline up to 12 hours after receipt of study drug
Results posted on
2026-09-01
Participant Flow
A total of 675 adult participants were recruited from 22 December 2022 to 23 March 2023.
Of 715 screened participants, 675 met eligibility criteria and were randomized to treatment.
Participant milestones
| Measure |
TNM002
Double blind, a single intramuscular injection of TNM002 on Day 1. Dosage: 10 mg
|
HTIG
Double blind, a single intramuscular injection of Human Tetanus Immunoglobulin (HTIG) 250 IU on Day 1.
Dosage: 250 IU (international unit)
|
|---|---|---|
|
Overall Study
STARTED
|
450
|
225
|
|
Overall Study
Participants Treated
|
440
|
221
|
|
Overall Study
COMPLETED
|
434
|
215
|
|
Overall Study
NOT COMPLETED
|
16
|
10
|
Reasons for withdrawal
| Measure |
TNM002
Double blind, a single intramuscular injection of TNM002 on Day 1. Dosage: 10 mg
|
HTIG
Double blind, a single intramuscular injection of Human Tetanus Immunoglobulin (HTIG) 250 IU on Day 1.
Dosage: 250 IU (international unit)
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
14
|
6
|
|
Overall Study
Protocol Violation
|
1
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
Study to Compare the Efficacy and Safety of Passive Immunization With TNM002 Injection and Human Tetanus Immunoglobulin as Prophylaxis Against Tetanus
Baseline characteristics by cohort
| Measure |
TNM002
n=440 Participants
Double blind, a single intramuscular injection of TNM002 on Day 1. Dosage: 10 mg
|
HTIG
n=221 Participants
Double blind, a single intramuscular injection of Human Tetanus Immunoglobulin (HTIG) 250 IU on Day 1.
Dosage: 250 IU (international unit)
|
Total
n=661 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.2 years
STANDARD_DEVIATION 12.17 • n=14 Participants
|
42.5 years
STANDARD_DEVIATION 12.93 • n=36 Participants
|
42.9 years
STANDARD_DEVIATION 12.43 • n=324 Participants
|
|
Age, Customized
Age, categorical · ≤65 years
|
430 Participants
n=14 Participants
|
214 Participants
n=36 Participants
|
644 Participants
n=324 Participants
|
|
Age, Customized
Age, categorical · > 65 to ≤ 75 years
|
9 Participants
n=14 Participants
|
6 Participants
n=36 Participants
|
15 Participants
n=324 Participants
|
|
Age, Customized
Age, categorical · > 75 years
|
1 Participants
n=14 Participants
|
1 Participants
n=36 Participants
|
2 Participants
n=324 Participants
|
|
Sex: Female, Male
Female
|
185 Participants
n=14 Participants
|
88 Participants
n=36 Participants
|
273 Participants
n=324 Participants
|
|
Sex: Female, Male
Male
|
255 Participants
n=14 Participants
|
133 Participants
n=36 Participants
|
388 Participants
n=324 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Han Chinese
|
425 Participants
n=14 Participants
|
210 Participants
n=36 Participants
|
635 Participants
n=324 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Other
|
15 Participants
n=14 Participants
|
11 Participants
n=36 Participants
|
26 Participants
n=324 Participants
|
|
Baseline anti-tetanus antibody titers
|
0.00729 IU/mL
n=14 Participants
|
0.00812 IU/mL
n=36 Participants
|
0.00756 IU/mL
n=324 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 12 hours after receipt of study drugPopulation: Particpants were excluded from the analysis due to early withdrawal and no available blood sample.
The change of anti-tetanus neutralizing antibody titers from baseline were defined as ΔTiters, calculated as the post-administration antibody titers minus the baseline antibody titers. The antibody protective level is ΔTiters ≥0.01 IU/mL.
Outcome measures
| Measure |
TNM002
n=438 Participants
Double blind, a single intramuscular injection of TNM002 on Day 1. Dosage: 10 mg
|
HTIG
n=220 Participants
Double blind, a single intramuscular injection of Human Tetanus Immunoglobulin (HTIG) 250 IU on Day 1.
Dosage: 250 IU (international unit)
|
|---|---|---|
|
Percentage of Participants With ∆Titers ≥0.01 IU/mL at 12 Hours Post-dose
|
418 Participants
|
117 Participants
|
SECONDARY outcome
Timeframe: Up to 28 days after receipt of study drugPopulation: There were 3 and 2 participants in the TNM002 and HTIG groups, respectively, who were lost to follow-up before 28 days after dosing.
The tetanus protection rate is defined as 1 minus the incidence of tetanus in the study population. The table presents the number of participants who remained free from clinical tetanus over the specified time frame.
Outcome measures
| Measure |
TNM002
n=437 Participants
Double blind, a single intramuscular injection of TNM002 on Day 1. Dosage: 10 mg
|
HTIG
n=219 Participants
Double blind, a single intramuscular injection of Human Tetanus Immunoglobulin (HTIG) 250 IU on Day 1.
Dosage: 250 IU (international unit)
|
|---|---|---|
|
Tetanus Protection Rate on Day 28 Post-dose
|
437 Participants
|
219 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 90 days after receipt of study drugPopulation: Participants were excluded from the analysis at each specified time point (D3, 7, 28, and 90) primarily due to the following: early withdrawal, no available blood sample, receipt of tetanus vaccine, and lost to follow-up. The vaccine could confound the efficacy assessment by actively boosting antibody levels. For the primary endpoint, vaccinated participants were not excluded because the impact of vaccination on efficacy assessment is negligible in the given timeframe (12 hours).
The change of anti-tetanus neutralizing antibody titers from baseline were defined as ΔTiters, calculated as the post-administration antibody titers minus the baseline antibody titers. The antibody protective level is ΔTiters ≥0.01 IU/mL.
Outcome measures
| Measure |
TNM002
n=389 Participants
Double blind, a single intramuscular injection of TNM002 on Day 1. Dosage: 10 mg
|
HTIG
n=195 Participants
Double blind, a single intramuscular injection of Human Tetanus Immunoglobulin (HTIG) 250 IU on Day 1.
Dosage: 250 IU (international unit)
|
|---|---|---|
|
Percentage of Participants With ΔTiters ≥0.01 IU/mL on Days 3, 7, 28, and 90 Post-dose.
Day 7
|
388 Participants
|
190 Participants
|
|
Percentage of Participants With ΔTiters ≥0.01 IU/mL on Days 3, 7, 28, and 90 Post-dose.
Day 3
|
388 Participants
|
187 Participants
|
|
Percentage of Participants With ΔTiters ≥0.01 IU/mL on Days 3, 7, 28, and 90 Post-dose.
Day 28
|
387 Participants
|
184 Participants
|
|
Percentage of Participants With ΔTiters ≥0.01 IU/mL on Days 3, 7, 28, and 90 Post-dose.
Day 90
|
353 Participants
|
19 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At 12 hours, and on Days 3, 7, 28 and 90 post-dosePopulation: Participants were excluded from the analysis at each specified time point (12h, D3, 7, 28, and 90) primarily due to the following: early withdrawal, no available blood sample, receipt of tetanus vaccine, and lost to follow-up. The vaccine could confound the efficacy assessment by actively boosting antibody levels. For the primary endpoint, vaccinated participants were not excluded because the impact of vaccination on efficacy assessment is negligible in the given timeframe (12 hours).
The change of anti-tetanus neutralizing antibody titers were defined as ΔTiters, calculated as the post-administration antibody titers minus the baseline antibody titers. The antibody protective level is ΔTiters \>0.01 IU/mL.
Outcome measures
| Measure |
TNM002
n=391 Participants
Double blind, a single intramuscular injection of TNM002 on Day 1. Dosage: 10 mg
|
HTIG
n=196 Participants
Double blind, a single intramuscular injection of Human Tetanus Immunoglobulin (HTIG) 250 IU on Day 1.
Dosage: 250 IU (international unit)
|
|---|---|---|
|
∆Titers at 12 Hours, and on Days 3, 7, 28 and 90 Post-dose
Day 90
|
0.0253 IU/mL
Interval 0.0236 to 0.0272
|
0.00429 IU/mL
Interval 0.00369 to 0.00495
|
|
∆Titers at 12 Hours, and on Days 3, 7, 28 and 90 Post-dose
12 hours
|
0.0602 IU/mL
Interval 0.0546 to 0.0663
|
0.0100 IU/mL
Interval 0.00883 to 0.0114
|
|
∆Titers at 12 Hours, and on Days 3, 7, 28 and 90 Post-dose
Day 3
|
0.187 IU/mL
Interval 0.174 to 0.201
|
0.0332 IU/mL
Interval 0.0304 to 0.0363
|
|
∆Titers at 12 Hours, and on Days 3, 7, 28 and 90 Post-dose
Day 7
|
0.233 IU/mL
Interval 0.22 to 0.247
|
0.0360 IU/mL
Interval 0.0335 to 0.0386
|
|
∆Titers at 12 Hours, and on Days 3, 7, 28 and 90 Post-dose
Day 28
|
0.156 IU/mL
Interval 0.15 to 0.163
|
0.0208 IU/mL
Interval 0.0192 to 0.0225
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 105 days after receipt of study drugPopulation: Participants were excluded from the analysis due to lost to follow-up.
The tetanus protection rate is defined as 1 minus the incidence of tetanus in the study population. The table presents the number of participants who remained free from clinical tetanus over the specified time frame.
Outcome measures
| Measure |
TNM002
n=437 Participants
Double blind, a single intramuscular injection of TNM002 on Day 1. Dosage: 10 mg
|
HTIG
n=217 Participants
Double blind, a single intramuscular injection of Human Tetanus Immunoglobulin (HTIG) 250 IU on Day 1.
Dosage: 250 IU (international unit)
|
|---|---|---|
|
Tetanus Protection Rate on Days 90 and 105 Post-dose
Day 90
|
437 Participants
|
217 Participants
|
|
Tetanus Protection Rate on Days 90 and 105 Post-dose
Day 105
|
432 Participants
|
214 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: pre-dose, 12h, and Days 3, 7, 28, 90 post-dosePopulation: The analysis included all TNM002-treated participants who had evaluable post-dose concentration data at each specified timepoint.
Arithmetic mean concentrations of TNM002 at each specified timepoint
Outcome measures
| Measure |
TNM002
n=438 Participants
Double blind, a single intramuscular injection of TNM002 on Day 1. Dosage: 10 mg
|
HTIG
Double blind, a single intramuscular injection of Human Tetanus Immunoglobulin (HTIG) 250 IU on Day 1.
Dosage: 250 IU (international unit)
|
|---|---|---|
|
TNM002 Serum Concentration
pre-dose
|
0 ng/mL
Standard Deviation 15.0
|
—
|
|
TNM002 Serum Concentration
12 hours
|
298 ng/mL
Standard Deviation 264
|
—
|
|
TNM002 Serum Concentration
Day 3
|
768 ng/mL
Standard Deviation 434
|
—
|
|
TNM002 Serum Concentration
Day 7
|
897 ng/mL
Standard Deviation 373
|
—
|
|
TNM002 Serum Concentration
Day 28
|
620 ng/mL
Standard Deviation 229
|
—
|
|
TNM002 Serum Concentration
Day 90
|
109 ng/mL
Standard Deviation 71.3
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: pre-dose, and Days 7, 28, and 90 post-dosePopulation: The analysis included all TNM002-treated participants who had evaluable post-dose immunogenicity data at each specified timepoint.
The positive rate of ADA in the TNM002 group at each specified timepoint
Outcome measures
| Measure |
TNM002
n=436 Participants
Double blind, a single intramuscular injection of TNM002 on Day 1. Dosage: 10 mg
|
HTIG
Double blind, a single intramuscular injection of Human Tetanus Immunoglobulin (HTIG) 250 IU on Day 1.
Dosage: 250 IU (international unit)
|
|---|---|---|
|
Anti-drug Antibodies (ADA) Against TNM002
Baseline
|
8 Participants
|
—
|
|
Anti-drug Antibodies (ADA) Against TNM002
Day 7
|
8 Participants
|
—
|
|
Anti-drug Antibodies (ADA) Against TNM002
Day 28
|
31 Participants
|
—
|
|
Anti-drug Antibodies (ADA) Against TNM002
Day 90
|
50 Participants
|
—
|
Adverse Events
TNM002
Serious events: 6 serious events
Other events: 131 other events
Deaths: 0 deaths
HTIG
Serious events: 2 serious events
Other events: 49 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
TNM002
n=440 participants at risk
Double blind, a single intramuscular injection of TNM002 on Day 1. Dosage: 10 mg
|
HTIG
n=221 participants at risk
Double blind, a single intramuscular injection of Human Tetanus Immunoglobulin (HTIG) 250 IU on Day 1.
Dosage: 250 IU (international unit)
|
|---|---|---|
|
Gastrointestinal disorders
Anal fistula
|
0.23%
1/440 • From enrollment until end of follow-up, up to 105 (±7) days post-dose
The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. If an adverse event changes in severity over time for the same participant, only the highest severity level observed is reported for that event, as pre-specified in the protocol. All adverse events meeting the reporting thresholds are included in the corresponding tables.
|
0.00%
0/221 • From enrollment until end of follow-up, up to 105 (±7) days post-dose
The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. If an adverse event changes in severity over time for the same participant, only the highest severity level observed is reported for that event, as pre-specified in the protocol. All adverse events meeting the reporting thresholds are included in the corresponding tables.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.23%
1/440 • From enrollment until end of follow-up, up to 105 (±7) days post-dose
The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. If an adverse event changes in severity over time for the same participant, only the highest severity level observed is reported for that event, as pre-specified in the protocol. All adverse events meeting the reporting thresholds are included in the corresponding tables.
|
0.00%
0/221 • From enrollment until end of follow-up, up to 105 (±7) days post-dose
The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. If an adverse event changes in severity over time for the same participant, only the highest severity level observed is reported for that event, as pre-specified in the protocol. All adverse events meeting the reporting thresholds are included in the corresponding tables.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.23%
1/440 • From enrollment until end of follow-up, up to 105 (±7) days post-dose
The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. If an adverse event changes in severity over time for the same participant, only the highest severity level observed is reported for that event, as pre-specified in the protocol. All adverse events meeting the reporting thresholds are included in the corresponding tables.
|
0.00%
0/221 • From enrollment until end of follow-up, up to 105 (±7) days post-dose
The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. If an adverse event changes in severity over time for the same participant, only the highest severity level observed is reported for that event, as pre-specified in the protocol. All adverse events meeting the reporting thresholds are included in the corresponding tables.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/440 • From enrollment until end of follow-up, up to 105 (±7) days post-dose
The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. If an adverse event changes in severity over time for the same participant, only the highest severity level observed is reported for that event, as pre-specified in the protocol. All adverse events meeting the reporting thresholds are included in the corresponding tables.
|
0.45%
1/221 • From enrollment until end of follow-up, up to 105 (±7) days post-dose
The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. If an adverse event changes in severity over time for the same participant, only the highest severity level observed is reported for that event, as pre-specified in the protocol. All adverse events meeting the reporting thresholds are included in the corresponding tables.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.23%
1/440 • From enrollment until end of follow-up, up to 105 (±7) days post-dose
The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. If an adverse event changes in severity over time for the same participant, only the highest severity level observed is reported for that event, as pre-specified in the protocol. All adverse events meeting the reporting thresholds are included in the corresponding tables.
|
0.00%
0/221 • From enrollment until end of follow-up, up to 105 (±7) days post-dose
The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. If an adverse event changes in severity over time for the same participant, only the highest severity level observed is reported for that event, as pre-specified in the protocol. All adverse events meeting the reporting thresholds are included in the corresponding tables.
|
|
Infections and infestations
Anal abscess
|
0.23%
1/440 • From enrollment until end of follow-up, up to 105 (±7) days post-dose
The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. If an adverse event changes in severity over time for the same participant, only the highest severity level observed is reported for that event, as pre-specified in the protocol. All adverse events meeting the reporting thresholds are included in the corresponding tables.
|
0.00%
0/221 • From enrollment until end of follow-up, up to 105 (±7) days post-dose
The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. If an adverse event changes in severity over time for the same participant, only the highest severity level observed is reported for that event, as pre-specified in the protocol. All adverse events meeting the reporting thresholds are included in the corresponding tables.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.23%
1/440 • From enrollment until end of follow-up, up to 105 (±7) days post-dose
The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. If an adverse event changes in severity over time for the same participant, only the highest severity level observed is reported for that event, as pre-specified in the protocol. All adverse events meeting the reporting thresholds are included in the corresponding tables.
|
0.00%
0/221 • From enrollment until end of follow-up, up to 105 (±7) days post-dose
The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. If an adverse event changes in severity over time for the same participant, only the highest severity level observed is reported for that event, as pre-specified in the protocol. All adverse events meeting the reporting thresholds are included in the corresponding tables.
|
|
General disorders
Death
|
0.00%
0/440 • From enrollment until end of follow-up, up to 105 (±7) days post-dose
The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. If an adverse event changes in severity over time for the same participant, only the highest severity level observed is reported for that event, as pre-specified in the protocol. All adverse events meeting the reporting thresholds are included in the corresponding tables.
|
0.45%
1/221 • From enrollment until end of follow-up, up to 105 (±7) days post-dose
The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. If an adverse event changes in severity over time for the same participant, only the highest severity level observed is reported for that event, as pre-specified in the protocol. All adverse events meeting the reporting thresholds are included in the corresponding tables.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/440 • From enrollment until end of follow-up, up to 105 (±7) days post-dose
The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. If an adverse event changes in severity over time for the same participant, only the highest severity level observed is reported for that event, as pre-specified in the protocol. All adverse events meeting the reporting thresholds are included in the corresponding tables.
|
0.45%
1/221 • From enrollment until end of follow-up, up to 105 (±7) days post-dose
The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. If an adverse event changes in severity over time for the same participant, only the highest severity level observed is reported for that event, as pre-specified in the protocol. All adverse events meeting the reporting thresholds are included in the corresponding tables.
|
Other adverse events
| Measure |
TNM002
n=440 participants at risk
Double blind, a single intramuscular injection of TNM002 on Day 1. Dosage: 10 mg
|
HTIG
n=221 participants at risk
Double blind, a single intramuscular injection of Human Tetanus Immunoglobulin (HTIG) 250 IU on Day 1.
Dosage: 250 IU (international unit)
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
9.3%
41/440 • From enrollment until end of follow-up, up to 105 (±7) days post-dose
The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. If an adverse event changes in severity over time for the same participant, only the highest severity level observed is reported for that event, as pre-specified in the protocol. All adverse events meeting the reporting thresholds are included in the corresponding tables.
|
4.5%
10/221 • From enrollment until end of follow-up, up to 105 (±7) days post-dose
The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. If an adverse event changes in severity over time for the same participant, only the highest severity level observed is reported for that event, as pre-specified in the protocol. All adverse events meeting the reporting thresholds are included in the corresponding tables.
|
|
Infections and infestations
Urinary tract infection
|
3.4%
15/440 • From enrollment until end of follow-up, up to 105 (±7) days post-dose
The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. If an adverse event changes in severity over time for the same participant, only the highest severity level observed is reported for that event, as pre-specified in the protocol. All adverse events meeting the reporting thresholds are included in the corresponding tables.
|
4.5%
10/221 • From enrollment until end of follow-up, up to 105 (±7) days post-dose
The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. If an adverse event changes in severity over time for the same participant, only the highest severity level observed is reported for that event, as pre-specified in the protocol. All adverse events meeting the reporting thresholds are included in the corresponding tables.
|
|
Infections and infestations
Covid-19
|
2.5%
11/440 • From enrollment until end of follow-up, up to 105 (±7) days post-dose
The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. If an adverse event changes in severity over time for the same participant, only the highest severity level observed is reported for that event, as pre-specified in the protocol. All adverse events meeting the reporting thresholds are included in the corresponding tables.
|
1.4%
3/221 • From enrollment until end of follow-up, up to 105 (±7) days post-dose
The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. If an adverse event changes in severity over time for the same participant, only the highest severity level observed is reported for that event, as pre-specified in the protocol. All adverse events meeting the reporting thresholds are included in the corresponding tables.
|
|
Infections and infestations
Bronchitis
|
1.6%
7/440 • From enrollment until end of follow-up, up to 105 (±7) days post-dose
The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. If an adverse event changes in severity over time for the same participant, only the highest severity level observed is reported for that event, as pre-specified in the protocol. All adverse events meeting the reporting thresholds are included in the corresponding tables.
|
0.45%
1/221 • From enrollment until end of follow-up, up to 105 (±7) days post-dose
The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. If an adverse event changes in severity over time for the same participant, only the highest severity level observed is reported for that event, as pre-specified in the protocol. All adverse events meeting the reporting thresholds are included in the corresponding tables.
|
|
Investigations
Urinary occult blood positive
|
1.6%
7/440 • From enrollment until end of follow-up, up to 105 (±7) days post-dose
The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. If an adverse event changes in severity over time for the same participant, only the highest severity level observed is reported for that event, as pre-specified in the protocol. All adverse events meeting the reporting thresholds are included in the corresponding tables.
|
1.4%
3/221 • From enrollment until end of follow-up, up to 105 (±7) days post-dose
The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. If an adverse event changes in severity over time for the same participant, only the highest severity level observed is reported for that event, as pre-specified in the protocol. All adverse events meeting the reporting thresholds are included in the corresponding tables.
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.4%
6/440 • From enrollment until end of follow-up, up to 105 (±7) days post-dose
The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. If an adverse event changes in severity over time for the same participant, only the highest severity level observed is reported for that event, as pre-specified in the protocol. All adverse events meeting the reporting thresholds are included in the corresponding tables.
|
0.45%
1/221 • From enrollment until end of follow-up, up to 105 (±7) days post-dose
The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. If an adverse event changes in severity over time for the same participant, only the highest severity level observed is reported for that event, as pre-specified in the protocol. All adverse events meeting the reporting thresholds are included in the corresponding tables.
|
|
Investigations
Transaminases increased
|
1.4%
6/440 • From enrollment until end of follow-up, up to 105 (±7) days post-dose
The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. If an adverse event changes in severity over time for the same participant, only the highest severity level observed is reported for that event, as pre-specified in the protocol. All adverse events meeting the reporting thresholds are included in the corresponding tables.
|
0.00%
0/221 • From enrollment until end of follow-up, up to 105 (±7) days post-dose
The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. If an adverse event changes in severity over time for the same participant, only the highest severity level observed is reported for that event, as pre-specified in the protocol. All adverse events meeting the reporting thresholds are included in the corresponding tables.
|
|
Investigations
Blood glucose increased
|
1.1%
5/440 • From enrollment until end of follow-up, up to 105 (±7) days post-dose
The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. If an adverse event changes in severity over time for the same participant, only the highest severity level observed is reported for that event, as pre-specified in the protocol. All adverse events meeting the reporting thresholds are included in the corresponding tables.
|
0.45%
1/221 • From enrollment until end of follow-up, up to 105 (±7) days post-dose
The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. If an adverse event changes in severity over time for the same participant, only the highest severity level observed is reported for that event, as pre-specified in the protocol. All adverse events meeting the reporting thresholds are included in the corresponding tables.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.3%
10/440 • From enrollment until end of follow-up, up to 105 (±7) days post-dose
The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. If an adverse event changes in severity over time for the same participant, only the highest severity level observed is reported for that event, as pre-specified in the protocol. All adverse events meeting the reporting thresholds are included in the corresponding tables.
|
2.3%
5/221 • From enrollment until end of follow-up, up to 105 (±7) days post-dose
The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. If an adverse event changes in severity over time for the same participant, only the highest severity level observed is reported for that event, as pre-specified in the protocol. All adverse events meeting the reporting thresholds are included in the corresponding tables.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.45%
2/440 • From enrollment until end of follow-up, up to 105 (±7) days post-dose
The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. If an adverse event changes in severity over time for the same participant, only the highest severity level observed is reported for that event, as pre-specified in the protocol. All adverse events meeting the reporting thresholds are included in the corresponding tables.
|
1.4%
3/221 • From enrollment until end of follow-up, up to 105 (±7) days post-dose
The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. If an adverse event changes in severity over time for the same participant, only the highest severity level observed is reported for that event, as pre-specified in the protocol. All adverse events meeting the reporting thresholds are included in the corresponding tables.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.6%
7/440 • From enrollment until end of follow-up, up to 105 (±7) days post-dose
The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. If an adverse event changes in severity over time for the same participant, only the highest severity level observed is reported for that event, as pre-specified in the protocol. All adverse events meeting the reporting thresholds are included in the corresponding tables.
|
0.45%
1/221 • From enrollment until end of follow-up, up to 105 (±7) days post-dose
The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. If an adverse event changes in severity over time for the same participant, only the highest severity level observed is reported for that event, as pre-specified in the protocol. All adverse events meeting the reporting thresholds are included in the corresponding tables.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
1.1%
5/440 • From enrollment until end of follow-up, up to 105 (±7) days post-dose
The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. If an adverse event changes in severity over time for the same participant, only the highest severity level observed is reported for that event, as pre-specified in the protocol. All adverse events meeting the reporting thresholds are included in the corresponding tables.
|
0.90%
2/221 • From enrollment until end of follow-up, up to 105 (±7) days post-dose
The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. If an adverse event changes in severity over time for the same participant, only the highest severity level observed is reported for that event, as pre-specified in the protocol. All adverse events meeting the reporting thresholds are included in the corresponding tables.
|
|
Nervous system disorders
Dizziness
|
1.1%
5/440 • From enrollment until end of follow-up, up to 105 (±7) days post-dose
The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. If an adverse event changes in severity over time for the same participant, only the highest severity level observed is reported for that event, as pre-specified in the protocol. All adverse events meeting the reporting thresholds are included in the corresponding tables.
|
2.3%
5/221 • From enrollment until end of follow-up, up to 105 (±7) days post-dose
The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. If an adverse event changes in severity over time for the same participant, only the highest severity level observed is reported for that event, as pre-specified in the protocol. All adverse events meeting the reporting thresholds are included in the corresponding tables.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.91%
4/440 • From enrollment until end of follow-up, up to 105 (±7) days post-dose
The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. If an adverse event changes in severity over time for the same participant, only the highest severity level observed is reported for that event, as pre-specified in the protocol. All adverse events meeting the reporting thresholds are included in the corresponding tables.
|
1.8%
4/221 • From enrollment until end of follow-up, up to 105 (±7) days post-dose
The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov. If an adverse event changes in severity over time for the same participant, only the highest severity level observed is reported for that event, as pre-specified in the protocol. All adverse events meeting the reporting thresholds are included in the corresponding tables.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60