Trial Outcomes & Findings for Non-Interventional Study To Investigate Whether Information Provided To Patients Influences Their Satisfaction With Toviaz Therapy (NCT NCT01091519)
NCT ID: NCT01091519
Last Updated: 2013-03-07
Results Overview
Participant's response to treatment was based on treatment satisfaction questionnaires (TSQ). Participants answered: "overall, how satisfied are you with your OAB medication?" and were asked to rate this question on 5 point scale as 1=very satisfied, 2=somewhat satisfied, 3= neither dissatisfied nor satisfied, 4=somewhat dissatisfied and 5=very dissatisfied. Five categorical responses were grouped to satisfied (including "very satisfied" and "somewhat satisfied") and dissatisfied (including "very dissatisfied", "somewhat dissatisfied", and "neither dissatisfied nor satisfied").
Recruitment status
TERMINATED
Target enrollment
781 participants
Primary outcome timeframe
Month 4
Results posted on
2013-03-07
Participant Flow
Participant milestones
| Measure |
Fesoterodine With Educational Materials
Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, with educational materials comprising of Self Assessment Goal Achievement (SAGA) tool. This tool included information to help the participants and follow their own treatment goals, as well as educational material on overactive bladder (OAB). Participants were observed for 4 months.
|
Fesoterodine Without Educational Materials
Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, without educational materials. Participants were observed for 4 months.
|
|---|---|---|
|
Overall Study
STARTED
|
346
|
435
|
|
Overall Study
Treated
|
342
|
431
|
|
Overall Study
COMPLETED
|
291
|
362
|
|
Overall Study
NOT COMPLETED
|
55
|
73
|
Reasons for withdrawal
| Measure |
Fesoterodine With Educational Materials
Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, with educational materials comprising of Self Assessment Goal Achievement (SAGA) tool. This tool included information to help the participants and follow their own treatment goals, as well as educational material on overactive bladder (OAB). Participants were observed for 4 months.
|
Fesoterodine Without Educational Materials
Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, without educational materials. Participants were observed for 4 months.
|
|---|---|---|
|
Overall Study
Adverse Event
|
12
|
16
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
16
|
19
|
|
Overall Study
Lost to Follow-up
|
14
|
24
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
|
Overall Study
Other
|
6
|
8
|
|
Overall Study
Randomized not treated
|
4
|
4
|
Baseline Characteristics
Non-Interventional Study To Investigate Whether Information Provided To Patients Influences Their Satisfaction With Toviaz Therapy
Baseline characteristics by cohort
| Measure |
Fesoterodine With Educational Materials
n=330 Participants
Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, with educational materials comprising of Self Assessment Goal Achievement (SAGA) tool. This tool included information to help the participants and follow their own treatment goals, as well as educational material on overactive bladder (OAB). Participants were observed for 4 months.
|
Fesoterodine Without Educational Materials
n=421 Participants
Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, without educational materials. Participants were observed for 4 months.
|
Total
n=751 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Less than (<) 18 years
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Age, Customized
18 to 44 years
|
20 participants
n=5 Participants
|
19 participants
n=7 Participants
|
39 participants
n=5 Participants
|
|
Age, Customized
45 to 64 years
|
114 participants
n=5 Participants
|
132 participants
n=7 Participants
|
246 participants
n=5 Participants
|
|
Age, Customized
Greater than or equal to (>=) 65 years
|
196 participants
n=5 Participants
|
270 participants
n=7 Participants
|
466 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
239 Participants
n=5 Participants
|
263 Participants
n=7 Participants
|
502 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
91 Participants
n=5 Participants
|
158 Participants
n=7 Participants
|
249 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 4Population: Full Analysis Set (FAS) included all participants who had received at least 1 dose of study medication and had provided at least 1 efficacy endpoint at baseline and during the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Participant's response to treatment was based on treatment satisfaction questionnaires (TSQ). Participants answered: "overall, how satisfied are you with your OAB medication?" and were asked to rate this question on 5 point scale as 1=very satisfied, 2=somewhat satisfied, 3= neither dissatisfied nor satisfied, 4=somewhat dissatisfied and 5=very dissatisfied. Five categorical responses were grouped to satisfied (including "very satisfied" and "somewhat satisfied") and dissatisfied (including "very dissatisfied", "somewhat dissatisfied", and "neither dissatisfied nor satisfied").
Outcome measures
| Measure |
Fesoterodine With Educational Materials
n=279 Participants
Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, with educational materials comprising of Self Assessment Goal Achievement (SAGA) tool. This tool included information to help the participants and follow their own treatment goals, as well as educational material on overactive bladder (OAB). Participants were observed for 4 months.
|
Fesoterodine Without Educational Materials
n=355 Participants
Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, without educational materials. Participants were observed for 4 months.
|
|---|---|---|
|
Percentage of Participants Satisfied With Treatment at Month 4
|
79.6 percentage of participants
Interval 74.4 to 84.1
|
76.1 percentage of participants
Interval 71.3 to 80.4
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Month 4Population: FAS included all participants who had received at least 1 dose of study medication and had provided at least 1 efficacy endpoint at baseline and during the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.
PPBC: single-item, self-administered validated questionnaire. Rated on a 6-point scale: participant was asked: "Which of the following statements describes your bladder condition best at the moment?" 1=no problems at all; 2=some very minor problems; 3=some minor problems; 4=some moderate problems; 5=severe problems; 6=many severe problems. Change from baseline results categorized as deterioration (Positive change from baseline); no Change (scores change=0); minor Improvement (negative score change in magnitude of 1); major improvement (negative score change in magnitude of \>=2).
Outcome measures
| Measure |
Fesoterodine With Educational Materials
n=266 Participants
Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, with educational materials comprising of Self Assessment Goal Achievement (SAGA) tool. This tool included information to help the participants and follow their own treatment goals, as well as educational material on overactive bladder (OAB). Participants were observed for 4 months.
|
Fesoterodine Without Educational Materials
n=368 Participants
Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, without educational materials. Participants were observed for 4 months.
|
|---|---|---|
|
Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4 and Month 4
Change at Month 4: Major improvement (n=252, 330)
|
164 participants
|
201 participants
|
|
Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4 and Month 4
Baseline: Severe problems (n=266, 368)
|
145 participants
|
179 participants
|
|
Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4 and Month 4
Baseline: Many severe problems (n=266, 368)
|
28 participants
|
48 participants
|
|
Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4 and Month 4
Change at Week 4: Deterioration (n=266, 368)
|
12 participants
|
14 participants
|
|
Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4 and Month 4
Change at Week 4: No change (n=266, 368)
|
57 participants
|
93 participants
|
|
Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4 and Month 4
Change at Week 4: Minor improvement (n=266, 368)
|
90 participants
|
107 participants
|
|
Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4 and Month 4
Change at Week 4: Major improvement (n=266, 368)
|
107 participants
|
154 participants
|
|
Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4 and Month 4
Change at Month 4: Deterioration (n=252, 330)
|
7 participants
|
4 participants
|
|
Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4 and Month 4
Change at Month 4: No change (n=252, 330)
|
32 participants
|
43 participants
|
|
Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4 and Month 4
Change at Month 4: Minor improvement (n=252, 330)
|
49 participants
|
82 participants
|
|
Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4 and Month 4
Baseline: No problem at all (n=266, 368)
|
1 participants
|
0 participants
|
|
Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4 and Month 4
Baseline: Some very minor problems (n=266, 368)
|
2 participants
|
3 participants
|
|
Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4 and Month 4
Baseline: Some minor problems (n=266, 368)
|
15 participants
|
16 participants
|
|
Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4 and Month 4
Baseline: Some moderate problems (n=266, 368)
|
75 participants
|
122 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Month 4Population: FAS included all participants who had received at least 1 dose of study medication and had provided at least 1 efficacy endpoint at baseline and during the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.
PPUS: single-item, self-administered validated questionnaire. Rated on a 3-point scale: participant was asked: "Which of the following would typically describe your experience when you have a desire to urinate?" 1=usually not able to hold urine; 2=usually able to hold urine (without leaking) until I reach a toilet if I go to the toilet immediately; 3= usually able to finish what I am doing before going to the toilet (without leaking). Change from baseline results categorized as deterioration (Negative change); no change (Score change=0); improvement (Positive change).
Outcome measures
| Measure |
Fesoterodine With Educational Materials
n=252 Participants
Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, with educational materials comprising of Self Assessment Goal Achievement (SAGA) tool. This tool included information to help the participants and follow their own treatment goals, as well as educational material on overactive bladder (OAB). Participants were observed for 4 months.
|
Fesoterodine Without Educational Materials
n=351 Participants
Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, without educational materials. Participants were observed for 4 months.
|
|---|---|---|
|
Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 4 and Month 4
Baseline: Usually not able hold urine (n=252, 351)
|
75 participants
|
116 participants
|
|
Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 4 and Month 4
Baseline: Usually able to hold urine (n=252, 351)
|
157 participants
|
186 participants
|
|
Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 4 and Month 4
Baseline: Usually able to finish (n=252, 351)
|
20 participants
|
49 participants
|
|
Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 4 and Month 4
Change at Week 4: Deterioration (n=252, 351)
|
19 participants
|
28 participants
|
|
Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 4 and Month 4
Change at Week 4: No Change (n=252, 351)
|
130 participants
|
174 participants
|
|
Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 4 and Month 4
Change at Week 4: Improvement (n=252, 351)
|
103 participants
|
149 participants
|
|
Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 4 and Month 4
Change at Month 4: Deterioration (n=238, 311)
|
29 participants
|
32 participants
|
|
Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 4 and Month 4
Change at Month 4: No Change (n=238, 311)
|
85 participants
|
109 participants
|
|
Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 4 and Month 4
Change at Month 4: Improvement (n=238, 311)
|
124 participants
|
170 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Month 4Population: FAS included all participants who had received at least 1 dose of study medication and had provided at least 1 efficacy endpoint at baseline and during the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.
Participant's response to the treatment was based on treatment satisfaction questionnaires (TSQ). TSQ was rated on a 5-point scale, participant was asked: "overall how satisfied are you with your over active bladder (OAB) medication?" 1=very satisfied, 2=somewhat satisfied, 3=neither dissatisfied nor satisfied, 4=somewhat dissatisfied, 5=very dissatisfied. Change from baseline results categorized as deterioration (Positive change from baseline);no change (scores change=0);minor improvement (negative score change in magnitude of 1);major improvement (negative score change in magnitude of \>=2).
Outcome measures
| Measure |
Fesoterodine With Educational Materials
n=144 Participants
Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, with educational materials comprising of Self Assessment Goal Achievement (SAGA) tool. This tool included information to help the participants and follow their own treatment goals, as well as educational material on overactive bladder (OAB). Participants were observed for 4 months.
|
Fesoterodine Without Educational Materials
n=203 Participants
Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, without educational materials. Participants were observed for 4 months.
|
|---|---|---|
|
Number of Participants With Change From Baseline in Treatment Satisfaction Question (TSQ) at Week 4 and Month 4
Baseline: Very Satisfied (n=144, 203)
|
2 participants
|
4 participants
|
|
Number of Participants With Change From Baseline in Treatment Satisfaction Question (TSQ) at Week 4 and Month 4
Baseline: Somewhat Satisfied (n=144, 203)
|
20 participants
|
29 participants
|
|
Number of Participants With Change From Baseline in Treatment Satisfaction Question (TSQ) at Week 4 and Month 4
Baseline:Neither Dissatisfied/Satisfied(n=144,203)
|
47 participants
|
54 participants
|
|
Number of Participants With Change From Baseline in Treatment Satisfaction Question (TSQ) at Week 4 and Month 4
Baseline: Somewhat Dissatisfied (n=144, 203)
|
60 participants
|
95 participants
|
|
Number of Participants With Change From Baseline in Treatment Satisfaction Question (TSQ) at Week 4 and Month 4
Baseline: Very Dissatisfied (n=144, 203)
|
15 participants
|
21 participants
|
|
Number of Participants With Change From Baseline in Treatment Satisfaction Question (TSQ) at Week 4 and Month 4
Change at Week 4: Deterioration (n=144, 203)
|
6 participants
|
16 participants
|
|
Number of Participants With Change From Baseline in Treatment Satisfaction Question (TSQ) at Week 4 and Month 4
Change at Week 4: No Change (n=144, 203)
|
45 participants
|
56 participants
|
|
Number of Participants With Change From Baseline in Treatment Satisfaction Question (TSQ) at Week 4 and Month 4
Change at Week 4: Minor Improvement (n=144, 203)
|
42 participants
|
56 participants
|
|
Number of Participants With Change From Baseline in Treatment Satisfaction Question (TSQ) at Week 4 and Month 4
Change at Week 4: Major Improvement (n=144, 203)
|
51 participants
|
75 participants
|
|
Number of Participants With Change From Baseline in Treatment Satisfaction Question (TSQ) at Week 4 and Month 4
Change at Month 4: Deterioration (n=143, 179)
|
2 participants
|
10 participants
|
|
Number of Participants With Change From Baseline in Treatment Satisfaction Question (TSQ) at Week 4 and Month 4
Change at Month 4: No Change (n=143, 179)
|
33 participants
|
38 participants
|
|
Number of Participants With Change From Baseline in Treatment Satisfaction Question (TSQ) at Week 4 and Month 4
Change at Month 4: Minor Improvement (n=143, 179)
|
51 participants
|
48 participants
|
|
Number of Participants With Change From Baseline in Treatment Satisfaction Question (TSQ) at Week 4 and Month 4
Change at Month 4: Major Improvement (n=143, 179)
|
57 participants
|
83 participants
|
Adverse Events
Fesoterodine With Educational Materials
Serious events: 2 serious events
Other events: 25 other events
Deaths: 0 deaths
Fesoterodine Without Educational Materials
Serious events: 1 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fesoterodine With Educational Materials
n=342 participants at risk
Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, with educational materials comprising of Self Assessment Goal Achievement (SAGA) tool. This tool included information to help the participants and follow their own treatment goals, as well as educational material on overactive bladder (OAB). Participants were observed for 4 months.
|
Fesoterodine Without Educational Materials
n=431 participants at risk
Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, without educational materials. Participants were observed for 4 months.
|
|---|---|---|
|
Nervous system disorders
Convulsion
|
0.00%
0/342
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
0.23%
1/431
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
|
Cardiac disorders
Myocardial infarction
|
0.29%
1/342
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
0.00%
0/431
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.29%
1/342
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
0.00%
0/431
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
Other adverse events
| Measure |
Fesoterodine With Educational Materials
n=342 participants at risk
Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, with educational materials comprising of Self Assessment Goal Achievement (SAGA) tool. This tool included information to help the participants and follow their own treatment goals, as well as educational material on overactive bladder (OAB). Participants were observed for 4 months.
|
Fesoterodine Without Educational Materials
n=431 participants at risk
Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, without educational materials. Participants were observed for 4 months.
|
|---|---|---|
|
Cardiac disorders
Cardiovascular disorder
|
0.29%
1/342
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
0.23%
1/431
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
|
Cardiac disorders
Palpitations
|
0.29%
1/342
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
0.00%
0/431
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/342
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
0.23%
1/431
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/342
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
0.46%
2/431
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
|
Eye disorders
Accommodation disorder
|
0.00%
0/342
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
0.23%
1/431
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
|
Eye disorders
Glaucoma
|
0.00%
0/342
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
0.23%
1/431
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
|
Eye disorders
Oscillopsia
|
0.29%
1/342
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
0.00%
0/431
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
|
Eye disorders
Visual impairment
|
0.00%
0/342
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
0.23%
1/431
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.29%
1/342
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
0.00%
0/431
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
|
Gastrointestinal disorders
Constipation
|
1.8%
6/342
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
0.70%
3/431
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
|
Gastrointestinal disorders
Dry mouth
|
3.8%
13/342
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
3.0%
13/431
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/342
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
0.23%
1/431
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/342
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
0.23%
1/431
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
|
Gastrointestinal disorders
Faeces hard
|
0.29%
1/342
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
0.00%
0/431
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
|
Gastrointestinal disorders
Gastric disorder
|
0.29%
1/342
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
0.00%
0/431
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
|
Gastrointestinal disorders
Gastritis
|
0.29%
1/342
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
0.23%
1/431
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
|
Gastrointestinal disorders
Nausea
|
0.88%
3/342
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
0.23%
1/431
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/342
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
0.23%
1/431
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
|
General disorders
Adverse event
|
0.00%
0/342
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
0.23%
1/431
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
|
General disorders
Face oedema
|
0.29%
1/342
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
0.00%
0/431
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
|
General disorders
Mucosal dryness
|
0.00%
0/342
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
0.23%
1/431
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
|
Infections and infestations
Cystitis
|
0.00%
0/342
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
0.46%
2/431
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/342
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
0.46%
2/431
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/342
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
0.23%
1/431
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/342
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
0.23%
1/431
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
|
Nervous system disorders
Headache
|
0.29%
1/342
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
0.00%
0/431
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/342
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
0.23%
1/431
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
|
Psychiatric disorders
Initial insomnia
|
0.00%
0/342
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
0.23%
1/431
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/342
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
0.23%
1/431
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
|
Renal and urinary disorders
Oliguria
|
0.29%
1/342
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
0.00%
0/431
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/342
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
0.46%
2/431
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.58%
2/342
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
0.00%
0/431
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.29%
1/342
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
0.00%
0/431
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/342
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
0.46%
2/431
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.29%
1/342
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
0.00%
0/431
Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER