Trial Outcomes & Findings for Korean Post Marketing Surveillance to Observe Effectiveness and Safety of PRISTIQ (NCT NCT02548949)
NCT ID: NCT02548949
Last Updated: 2021-02-09
Results Overview
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Recruitment status
COMPLETED
Target enrollment
700 participants
Primary outcome timeframe
Up to 8 weeks
Results posted on
2021-02-09
Participant Flow
Participant milestones
| Measure |
Pristiq
Participants who were receiving Pristiq tablets as part of routine practice at Korean health care centers were enrolled and observed in this study for up to 8 weeks since the start of Pristiq administration.
|
|---|---|
|
Overall Study
STARTED
|
700
|
|
Overall Study
COMPLETED
|
700
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Pristiq
n=700 Participants
Participants who were receiving Pristiq tablets as part of routine practice at Korean health care centers were enrolled and observed in this study for up to 8 weeks since the start of Pristiq administration.
|
|---|---|
|
Age, Continuous
|
58.23 years
STANDARD_DEVIATION 17.67 • n=700 Participants
|
|
Sex: Female, Male
Female
|
455 Participants
n=700 Participants
|
|
Sex: Female, Male
Male
|
245 Participants
n=700 Participants
|
PRIMARY outcome
Timeframe: Up to 8 weeksPopulation: Safety analysis set included all participants who had been administered Pristiq at least once and completed follow up.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Outcome measures
| Measure |
Pristiq
n=700 Participants
Participants who were receiving Pristiq tablets as part of routine practice at Korean health care centers were enrolled and observed in this study for up to 8 weeks since the start of Pristiq administration.
|
|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
80 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
3 Participants
|
PRIMARY outcome
Timeframe: At Week 8Population: Effectiveness analysis set included all participants who had been administered Pristiq at least once and were evaluated upon its related effectiveness outcomes at least once. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
CGI-I scale was a 7-point scale used to assess clinical effectiveness on a range of 1 to 7; where, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = No change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. Higher score indicated worse condition/lower clinical effectiveness.
Outcome measures
| Measure |
Pristiq
n=454 Participants
Participants who were receiving Pristiq tablets as part of routine practice at Korean health care centers were enrolled and observed in this study for up to 8 weeks since the start of Pristiq administration.
|
|---|---|
|
Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale
Very much improved
|
22 Participants
|
|
Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale
Much improved
|
128 Participants
|
|
Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale
Minimally improved
|
237 Participants
|
|
Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale
No change
|
65 Participants
|
|
Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale
Minimally worse
|
2 Participants
|
|
Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale
Much worse
|
0 Participants
|
|
Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale
Very much worse
|
0 Participants
|
PRIMARY outcome
Timeframe: At Week 8Population: Effectiveness analysis set included all participants who had been administered Pristiq at least once and were evaluated upon its related effectiveness outcomes at least once.
Final effectiveness was evaluated as 'improved', 'no change', 'worse' or 'unevaluable' based on overall participant's clinical response after 8 weeks of Pristiq administration (as part of routine care), where, Improved = there was the improvement of symptoms related to major depressive disorder, No change = there was no significant change compared to participant's status before Pristiq administration, Worse = symptoms were getting worse compared to participant's status before Pristiq administration, Unevaluable = the medical charts do not had adequate progress notes to make a judgment on clinical response.
Outcome measures
| Measure |
Pristiq
n=479 Participants
Participants who were receiving Pristiq tablets as part of routine practice at Korean health care centers were enrolled and observed in this study for up to 8 weeks since the start of Pristiq administration.
|
|---|---|
|
Number of Participants With Final Effectiveness Evaluation
Improved
|
411 Participants
|
|
Number of Participants With Final Effectiveness Evaluation
No change
|
68 Participants
|
|
Number of Participants With Final Effectiveness Evaluation
Worse
|
0 Participants
|
|
Number of Participants With Final Effectiveness Evaluation
Unevaluable
|
0 Participants
|
Adverse Events
Pristiq
Serious events: 3 serious events
Other events: 80 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pristiq
n=700 participants at risk
Participants who were receiving Pristiq tablets as part of routine practice at Korean health care centers were enrolled and observed in this study for up to 8 weeks since the start of Pristiq administration.
|
|---|---|
|
General disorders
Chest pain
|
0.14%
1/700 • Up to 8 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants who had been administered Pristiq at least once and completed follow up.
|
|
Cardiac disorders
Angina pectoris aggravated
|
0.14%
1/700 • Up to 8 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants who had been administered Pristiq at least once and completed follow up.
|
|
Nervous system disorders
Tremor
|
0.14%
1/700 • Up to 8 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants who had been administered Pristiq at least once and completed follow up.
|
Other adverse events
| Measure |
Pristiq
n=700 participants at risk
Participants who were receiving Pristiq tablets as part of routine practice at Korean health care centers were enrolled and observed in this study for up to 8 weeks since the start of Pristiq administration.
|
|---|---|
|
General disorders
Asthenia
|
0.29%
2/700 • Up to 8 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants who had been administered Pristiq at least once and completed follow up.
|
|
General disorders
Chest pain
|
0.29%
2/700 • Up to 8 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants who had been administered Pristiq at least once and completed follow up.
|
|
General disorders
Face oedema
|
0.14%
1/700 • Up to 8 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants who had been administered Pristiq at least once and completed follow up.
|
|
General disorders
Fatigue
|
0.14%
1/700 • Up to 8 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants who had been administered Pristiq at least once and completed follow up.
|
|
General disorders
Fever
|
0.29%
2/700 • Up to 8 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants who had been administered Pristiq at least once and completed follow up.
|
|
General disorders
Medicine ineffective
|
0.14%
1/700 • Up to 8 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants who had been administered Pristiq at least once and completed follow up.
|
|
General disorders
Oedema generalised
|
0.14%
1/700 • Up to 8 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants who had been administered Pristiq at least once and completed follow up.
|
|
Cardiac disorders
Hypertension
|
0.14%
1/700 • Up to 8 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants who had been administered Pristiq at least once and completed follow up.
|
|
Nervous system disorders
Dizziness
|
0.57%
4/700 • Up to 8 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants who had been administered Pristiq at least once and completed follow up.
|
|
Nervous system disorders
Headache
|
1.4%
10/700 • Up to 8 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants who had been administered Pristiq at least once and completed follow up.
|
|
Nervous system disorders
Tremor
|
0.57%
4/700 • Up to 8 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants who had been administered Pristiq at least once and completed follow up.
|
|
Musculoskeletal and connective tissue disorders
Arthritis rheumatoid aggravated
|
0.14%
1/700 • Up to 8 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants who had been administered Pristiq at least once and completed follow up.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.14%
1/700 • Up to 8 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants who had been administered Pristiq at least once and completed follow up.
|
|
Gastrointestinal disorders
Appetite decreased
|
0.29%
2/700 • Up to 8 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants who had been administered Pristiq at least once and completed follow up.
|
|
Gastrointestinal disorders
Constipation
|
0.71%
5/700 • Up to 8 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants who had been administered Pristiq at least once and completed follow up.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.29%
2/700 • Up to 8 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants who had been administered Pristiq at least once and completed follow up.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.57%
4/700 • Up to 8 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants who had been administered Pristiq at least once and completed follow up.
|
|
Gastrointestinal disorders
Enteritis
|
0.14%
1/700 • Up to 8 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants who had been administered Pristiq at least once and completed follow up.
|
|
Gastrointestinal disorders
Gastritis
|
0.29%
2/700 • Up to 8 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants who had been administered Pristiq at least once and completed follow up.
|
|
Gastrointestinal disorders
Gastroesophageal reflux
|
0.14%
1/700 • Up to 8 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants who had been administered Pristiq at least once and completed follow up.
|
|
Gastrointestinal disorders
Mouth dry
|
0.29%
2/700 • Up to 8 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants who had been administered Pristiq at least once and completed follow up.
|
|
Gastrointestinal disorders
Nausea
|
2.0%
14/700 • Up to 8 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants who had been administered Pristiq at least once and completed follow up.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.14%
1/700 • Up to 8 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants who had been administered Pristiq at least once and completed follow up.
|
|
Gastrointestinal disorders
Vomiting
|
0.43%
3/700 • Up to 8 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants who had been administered Pristiq at least once and completed follow up.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.14%
1/700 • Up to 8 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants who had been administered Pristiq at least once and completed follow up.
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.14%
1/700 • Up to 8 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants who had been administered Pristiq at least once and completed follow up.
|
|
Cardiac disorders
Palpitation
|
0.57%
4/700 • Up to 8 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants who had been administered Pristiq at least once and completed follow up.
|
|
Psychiatric disorders
Agitation
|
0.29%
2/700 • Up to 8 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants who had been administered Pristiq at least once and completed follow up.
|
|
Psychiatric disorders
Anxiety
|
0.57%
4/700 • Up to 8 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants who had been administered Pristiq at least once and completed follow up.
|
|
Psychiatric disorders
Globus hystericus
|
0.14%
1/700 • Up to 8 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants who had been administered Pristiq at least once and completed follow up.
|
|
Psychiatric disorders
Insomnia
|
0.86%
6/700 • Up to 8 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants who had been administered Pristiq at least once and completed follow up.
|
|
Psychiatric disorders
Somnolence
|
1.4%
10/700 • Up to 8 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants who had been administered Pristiq at least once and completed follow up.
|
|
Psychiatric disorders
Thinking abnormal
|
0.29%
2/700 • Up to 8 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants who had been administered Pristiq at least once and completed follow up.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
0.29%
2/700 • Up to 8 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants who had been administered Pristiq at least once and completed follow up.
|
|
Musculoskeletal and connective tissue disorders
Sjogren's syndrome
|
0.14%
1/700 • Up to 8 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants who had been administered Pristiq at least once and completed follow up.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.14%
1/700 • Up to 8 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants who had been administered Pristiq at least once and completed follow up.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.29%
2/700 • Up to 8 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants who had been administered Pristiq at least once and completed follow up.
|
|
Skin and subcutaneous tissue disorders
Diaphoresis
|
0.29%
2/700 • Up to 8 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants who had been administered Pristiq at least once and completed follow up.
|
|
Renal and urinary disorders
Dysuria
|
0.14%
1/700 • Up to 8 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants who had been administered Pristiq at least once and completed follow up.
|
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