Trial Outcomes & Findings for Toviaz Post Marketing Surveillance Study (NCT NCT00879398)
NCT ID: NCT00879398
Last Updated: 2015-10-21
Results Overview
An AE was any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event was not necessarily had a causal relationship with the treatment or usage. All AEs reported after start of administration of Toviaz were considered as TEAEs.
Recruitment status
COMPLETED
Target enrollment
3000 participants
Primary outcome timeframe
From the time that the participant signed data privacy statement through and including 28 calendar days after the last administration of the study drug.
Results posted on
2015-10-21
Participant Flow
Participants were enrolled between November 2009 and August 2014 from 235 Korean medical care centers.
Participant milestones
| Measure |
Toviaz
Participants were administered with Toviaz as part of routine care. The use and dosage recommendations for Toviaz were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
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|---|---|
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Overall Study
STARTED
|
3109
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Overall Study
COMPLETED
|
2434
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Overall Study
NOT COMPLETED
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675
|
Reasons for withdrawal
| Measure |
Toviaz
Participants were administered with Toviaz as part of routine care. The use and dosage recommendations for Toviaz were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
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|---|---|
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Overall Study
Visit Stop
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399
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Overall Study
Lack of Efficacy
|
64
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Overall Study
Adverse Event
|
41
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Overall Study
Other Reasons
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171
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Baseline Characteristics
Toviaz Post Marketing Surveillance Study
Baseline characteristics by cohort
| Measure |
Toviaz
n=3107 Participants
Participants were administered with Toviaz as part of routine care. The use and dosage recommendations for Toviaz were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
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|---|---|
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Age, Continuous
|
60.22 Years
STANDARD_DEVIATION 13.98 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1520 Participants
n=5 Participants
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Sex: Female, Male
Male
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1587 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: From the time that the participant signed data privacy statement through and including 28 calendar days after the last administration of the study drug.Population: Safety Analysis Set
An AE was any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event was not necessarily had a causal relationship with the treatment or usage. All AEs reported after start of administration of Toviaz were considered as TEAEs.
Outcome measures
| Measure |
Toviaz
n=3107 Participants
Participants were administered with Toviaz as part of routine care. The use and dosage recommendations for Toviaz were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
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|---|---|
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Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
|
8.53 Percentage of Participants
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PRIMARY outcome
Timeframe: At the end of study treatmentPopulation: Per-Protocol (PP) Population: participants who had evaluable data and were eligible for the efficacy assessment of the approved indication. The method of last observation carried forward was used in the analysis of effectiveness endpoints.
The final efficacy assessment included improvement, no change, aggravation, and unevaluable evaluated by the investigator based on the subject's symptoms of frequent micturition, urgency, and urgency urinary incontinence (UUI).
Outcome measures
| Measure |
Toviaz
n=2978 Participants
Participants were administered with Toviaz as part of routine care. The use and dosage recommendations for Toviaz were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
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|---|---|
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Investigator's Final Assessment of Effectiveness at the End of Study Treatment
Improvement
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90.13 Percentage of Participants
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Investigator's Final Assessment of Effectiveness at the End of Study Treatment
No Change
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9.50 Percentage of Participants
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Investigator's Final Assessment of Effectiveness at the End of Study Treatment
Aggravation
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0.37 Percentage of Participants
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SECONDARY outcome
Timeframe: Baseline and at the end of study treatmentPopulation: PP Population; n refers to the number of participants with evaluable data.
The number of micturitions per 24 hours was recorded in the case report form (CRF) by the investigator. Baseline was defined as data collected within 1 week prior to the first visit.
Outcome measures
| Measure |
Toviaz
n=2718 Participants
Participants were administered with Toviaz as part of routine care. The use and dosage recommendations for Toviaz were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
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|---|---|
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Change From Baseline in Number of Micturitions Per 24 Hours at the End of Study Treatment
Baseline (n=2718)
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12.05 Number of Episodes per 24 Hours
Standard Deviation 3.20
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Change From Baseline in Number of Micturitions Per 24 Hours at the End of Study Treatment
End of Study Treatment (n=2718)
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8.04 Number of Episodes per 24 Hours
Standard Deviation 2.35
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Change From Baseline in Number of Micturitions Per 24 Hours at the End of Study Treatment
Change from Baseline (n=2718)
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-4.02 Number of Episodes per 24 Hours
Standard Deviation 2.66
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SECONDARY outcome
Timeframe: Baseline and at the end of study treatmentPopulation: PP Population; n refers to the number of participants with evaluable data.
The number of urgency episodes per 24 hours was recorded in the CRF by the investigator. Baseline was defined as data collected within 1 week prior to the first visit.
Outcome measures
| Measure |
Toviaz
n=2724 Participants
Participants were administered with Toviaz as part of routine care. The use and dosage recommendations for Toviaz were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
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|---|---|
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Change From Baseline in Number of Urgency Episodes Per 24 Hours at the End of Study Treatment
Baseline (n=2724)
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3.65 Number of Episodes per 24 Hours
Standard Deviation 3.58
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Change From Baseline in Number of Urgency Episodes Per 24 Hours at the End of Study Treatment
End of Study Treatment (n=2724)
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1.27 Number of Episodes per 24 Hours
Standard Deviation 2.05
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Change From Baseline in Number of Urgency Episodes Per 24 Hours at the End of Study Treatment
Change from Baseline (n=2724)
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-2.37 Number of Episodes per 24 Hours
Standard Deviation 2.67
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SECONDARY outcome
Timeframe: Baseline and at the end of study treatmentPopulation: PP Population; n refers to the number of participants with evaluable data.
The number of UUI episodes per 24 hours was recorded in the CRF by the investigator. Baseline was defined as data collected within 1 week prior to the first visit.
Outcome measures
| Measure |
Toviaz
n=2800 Participants
Participants were administered with Toviaz as part of routine care. The use and dosage recommendations for Toviaz were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
|
|---|---|
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Change From Baseline in Number of UUI Episodes Per 24 Hours at the End of Study Treatment
Baseline (n=2800)
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1.07 Number of Episodes per 24 Hours
Standard Deviation 2.05
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Change From Baseline in Number of UUI Episodes Per 24 Hours at the End of Study Treatment
End of study treatment (n=2800)
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0.27 Number of Episodes per 24 Hours
Standard Deviation 0.89
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Change From Baseline in Number of UUI Episodes Per 24 Hours at the End of Study Treatment
Change from baseline (n=2800)
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-0.80 Number of Episodes per 24 Hours
Standard Deviation 1.65
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SECONDARY outcome
Timeframe: Baseline and at the end of study treatmentPopulation: PP Population
Participant perception of bladder condition was recorded in the CRF by the investigator. Participants were asked at baseline (BL) and at the end of study treatment (EOT) if the extent to which their bladder condition caused them problems. The possible responses were: No Problem, Very Minor Problems, Minor Problems, Moderate Problems, Severe Problems, or Many Severe Problems.
Outcome measures
| Measure |
Toviaz
n=2939 Participants
Participants were administered with Toviaz as part of routine care. The use and dosage recommendations for Toviaz were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
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|---|---|
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Participant Perception of Bladder Condition at the End of Study Treatment
BL: No Problem/EOT: No problem
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0 Participants
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Participant Perception of Bladder Condition at the End of Study Treatment
BL: No Problem/EOT: Very Minor Problems
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0 Participants
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Participant Perception of Bladder Condition at the End of Study Treatment
BL: No Problem/EOT: Minor Problems
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0 Participants
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Participant Perception of Bladder Condition at the End of Study Treatment
BL: No Problem/EOT: Moderate Problems
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1 Participants
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Participant Perception of Bladder Condition at the End of Study Treatment
BL: No Problem/EOT: Severe Problems
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0 Participants
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Participant Perception of Bladder Condition at the End of Study Treatment
BL: No Problem/EOT: Many Severe Problems
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0 Participants
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Participant Perception of Bladder Condition at the End of Study Treatment
BL: Very Minor Problems/EOT:No Problem
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29 Participants
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Participant Perception of Bladder Condition at the End of Study Treatment
BL:Very Minor Problems/EOT: Very Minor Problems
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33 Participants
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Participant Perception of Bladder Condition at the End of Study Treatment
BL: Very Minor Problems/EOT: Minor Problems
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0 Participants
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Participant Perception of Bladder Condition at the End of Study Treatment
BL: Very Minor Problems/EOT: Moderate Problems
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0 Participants
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Participant Perception of Bladder Condition at the End of Study Treatment
BL: Very Minor Problems/EOT: Severe Problems
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0 Participants
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Participant Perception of Bladder Condition at the End of Study Treatment
BL: Very Minor Problems/EOT: Many Severe Problems
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0 Participants
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Participant Perception of Bladder Condition at the End of Study Treatment
BL: Minor Problems/EOT: No Problem
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105 Participants
|
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Participant Perception of Bladder Condition at the End of Study Treatment
BL: Minor Problems/EOT: Very Minor Problems
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134 Participants
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Participant Perception of Bladder Condition at the End of Study Treatment
BL: Minor Problems/EOT: Minor Problems
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42 Participants
|
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Participant Perception of Bladder Condition at the End of Study Treatment
BL: Minor Problems/EOT:Moderate Problems
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1 Participants
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Participant Perception of Bladder Condition at the End of Study Treatment
BL: Minor Problems/EOT: Severe Problems
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0 Participants
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Participant Perception of Bladder Condition at the End of Study Treatment
BL: Minor Problems/EOT: Many Severe Problems
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0 Participants
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Participant Perception of Bladder Condition at the End of Study Treatment
BL: Moderate Problems/EOT: No Problem
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224 Participants
|
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Participant Perception of Bladder Condition at the End of Study Treatment
BL: Moderate Problems/EOT: Very Minor Problems
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447 Participants
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Participant Perception of Bladder Condition at the End of Study Treatment
BL: Moderate Problems/EOT: Minor Problems
|
171 Participants
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Participant Perception of Bladder Condition at the End of Study Treatment
BL: Moderate Problems/EOT: Moderate Problems
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116 Participants
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Participant Perception of Bladder Condition at the End of Study Treatment
BL: Moderate Problems/EOT: Severe Problems
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3 Participants
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Participant Perception of Bladder Condition at the End of Study Treatment
BL: Moderate Problems/EOT: Many Severe Problems
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1 Participants
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Participant Perception of Bladder Condition at the End of Study Treatment
BL: Severe Problems/EOT: No Problem
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188 Participants
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Participant Perception of Bladder Condition at the End of Study Treatment
BL: Severe Problems/EOT: Very Minor Problems
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456 Participants
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Participant Perception of Bladder Condition at the End of Study Treatment
BL: Severe Problems/EOT: Minor Problems
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227 Participants
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Participant Perception of Bladder Condition at the End of Study Treatment
BL: Severe Problems/EOT: Moderate Problems
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97 Participants
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Participant Perception of Bladder Condition at the End of Study Treatment
BL: Severe Problems/EOT: Severe Problems
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49 Participants
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Participant Perception of Bladder Condition at the End of Study Treatment
BL: Severe Problems/EOT: Many Severe Problems
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0 Participants
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Participant Perception of Bladder Condition at the End of Study Treatment
BL: Many Severe Problems/EOT: No Problem
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105 Participants
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Participant Perception of Bladder Condition at the End of Study Treatment
BL: Many Severe Problems/EOT: Very Minor Problems
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195 Participants
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Participant Perception of Bladder Condition at the End of Study Treatment
BL: Many Severe Problems/EOT: Minor Problems
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148 Participants
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Participant Perception of Bladder Condition at the End of Study Treatment
BL: Many Severe Problems/EOT: Moderate Problems
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97 Participants
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Participant Perception of Bladder Condition at the End of Study Treatment
BL: Many Severe Problems/EOT: Severe Problems
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51 Participants
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Participant Perception of Bladder Condition at the End of Study Treatment
BL: Many Severe Problems/EOT: Many Severe Problems
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19 Participants
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SECONDARY outcome
Timeframe: At the end of study treatmentPopulation: PP Population
Participants who were assessed as having improved from their baseline condition in the final efficacy assessment were considered as "effective". Baseline and treatment characteristics included: geriatric status (\<65 years or ≥65 years), age categories, gender, weight categories, height categories, allergic history, duration of disease, past overactive bladder (OAB) treatment history, medical history, kidney and liver disorders, concomitant medication, total administration period of Toviaz, completion status, daily dose of Toviaz, and long term administration of Toviaz (\<274 days and ≥274 days) .
Outcome measures
| Measure |
Toviaz
n=2978 Participants
Participants were administered with Toviaz as part of routine care. The use and dosage recommendations for Toviaz were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
|
|---|---|
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Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics
Completion
|
92.28 Percentage of Participants
Interval 91.22 to 92.3
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Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics
All Participants
|
90.13 Percentage of Participants
Interval 89.06 to 90.15
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Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics
Geriatric Status: <65 years
|
90.86 Percentage of Participants
Interval 89.47 to 90.89
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Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics
Geriatric Status: ≥65 years
|
89.20 Percentage of Participants
Interval 87.52 to 89.25
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Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics
Age Category: <50 years
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91.27 Percentage of Participants
Interval 89.07 to 91.36
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Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics
Age Category: 50 to 59 years
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91.08 Percentage of Participants
Interval 88.87 to 91.17
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Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics
Age Category: 60 to 69 years
|
89.29 Percentage of Participants
Interval 87.22 to 89.36
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Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics
Age Category: 70 to 79 years
|
89.45 Percentage of Participants
Interval 87.13 to 89.54
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Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics
Age Category: ≥80 years
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89.27 Percentage of Participants
Interval 84.71 to 89.61
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Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics
Gender: Male
|
88.98 Percentage of Participants
Interval 87.41 to 89.02
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Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics
Gender: Female
|
91.36 Percentage of Participants
Interval 89.91 to 91.4
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Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics
Weight Category: <50 kg
|
89.73 Percentage of Participants
Interval 85.36 to 90.05
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Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics
Weight Category: 50 to <60 kg
|
91.64 Percentage of Participants
Interval 89.72 to 91.7
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Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics
Weight Category: 60 to <70 kg
|
90.32 Percentage of Participants
Interval 88.47 to 90.38
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Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics
Weight Category: ≥70 kg
|
88.82 Percentage of Participants
Interval 86.59 to 88.9
|
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Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics
Height Category: <160 cm
|
89.99 Percentage of Participants
Interval 87.93 to 90.06
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Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics
Height Category: 160 to 170 cm
|
90.32 Percentage of Participants
Interval 88.57 to 90.37
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Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics
Height Category: ≥170 cm
|
90.35 Percentage of Participants
Interval 88.33 to 90.42
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Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics
Allergic History: Yes
|
82.22 Percentage of Participants
Interval 71.05 to 83.89
|
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Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics
Allergic History: No
|
90.25 Percentage of Participants
Interval 89.18 to 90.27
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Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics
Duration of Disease: <1 week
|
92.40 Percentage of Participants
Interval 91.18 to 92.43
|
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Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics
Duration of Disease: 1 to <8 weeks
|
89.42 Percentage of Participants
Interval 85.9 to 89.63
|
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Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics
Duration of Disease: 8 to <16 weeks
|
89.05 Percentage of Participants
Interval 83.82 to 89.5
|
|
Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics
Duration of Disease: ≥16 weeks
|
84.33 Percentage of Participants
Interval 81.54 to 84.44
|
|
Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics
Past OAB Treatment History: Yes
|
85.30 Percentage of Participants
Interval 82.79 to 85.39
|
|
Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics
Past OAB Treatment History: No
|
91.79 Percentage of Participants
Interval 90.64 to 91.81
|
|
Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics
Existence for Medical History of Past Disease: Yes
|
87.96 Percentage of Participants
Interval 84.8 to 88.12
|
|
Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics
Existence for Medical History of Past Disease: No
|
90.47 Percentage of Participants
Interval 89.34 to 90.49
|
|
Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics
Medical History of Present Disease: Yes
|
87.96 Percentage of Participants
Interval 86.34 to 88.0
|
|
Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics
Medical History of Present Disease: No
|
92.46 Percentage of Participants
Interval 91.1 to 92.5
|
|
Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics
Kidney Disease: Yes
|
90.00 Percentage of Participants
Interval 71.41 to 95.88
|
|
Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics
Kidney Disease: No
|
90.13 Percentage of Participants
Interval 89.05 to 90.15
|
|
Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics
Liver Disorder: Yes
|
92.31 Percentage of Participants
Interval 77.82 to 96.33
|
|
Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics
Liver Disorder: No
|
90.12 Percentage of Participants
Interval 89.04 to 90.14
|
|
Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics
Administration Period of Toviaz: <2 months
|
85.22 Percentage of Participants
Interval 82.96 to 85.29
|
|
Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics
Administration Period of Toviaz: 2 to <4 months
|
92.44 Percentage of Participants
Interval 91.16 to 92.47
|
|
Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics
Administration Period Of Toviaz: ≥ 4 months
|
92.33 Percentage of Participants
Interval 89.64 to 92.47
|
|
Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics
Daily Dose of Toviaz: 3 mg
|
66.67 Percentage of Participants
Interval 13.32 to 97.47
|
|
Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics
Daily Dose of Toviaz: 4 mg
|
90.65 Percentage of Participants
Interval 89.51 to 90.68
|
|
Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics
Daily Dose of Toviaz: >4 to <8 mg
|
85.25 Percentage of Participants
Interval 80.8 to 85.53
|
|
Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics
Daily Dose of Toviaz: 8 mg
|
90.25 Percentage of Participants
Interval 86.47 to 90.5
|
|
Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics
Discontinuation
|
80.72 Percentage of Participants
Interval 77.44 to 80.86
|
|
Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics
Total Administration Period <274 days
|
90.16 Percentage of Participants
Interval 89.09 to 90.18
|
|
Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics
Total Administration Period ≥274 days
|
87.50 Percentage of Participants
Interval 77.25 to 89.12
|
|
Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics
Existence for Concurrent Medication: Yes
|
88.48 Percentage of Participants
Interval 86.92 to 88.51
|
|
Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics
Existence for Concurrent Medication: No
|
92.08 Percentage of Participants
Interval 90.65 to 92.12
|
Adverse Events
Toviaz
Serious events: 0 serious events
Other events: 219 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Toviaz
n=3107 participants at risk
Participants were administered with Toviaz as part of routine care. The use and dosage recommendations for Toviaz were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
1.5%
48/3107 • From the time that the participant signed data privacy statement through and including 28 calendar days after the last administration of the study drug.
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Mouth dry
|
5.4%
168/3107 • From the time that the participant signed data privacy statement through and including 28 calendar days after the last administration of the study drug.
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Micturition disorder
|
1.1%
35/3107 • From the time that the participant signed data privacy statement through and including 28 calendar days after the last administration of the study drug.
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60