Trial Outcomes & Findings for Study Comparing Discontinuation Symptoms Of DVS SR In Subjects With Major Depressive Disorder (MDD) (NCT NCT01056289)
NCT ID: NCT01056289
Last Updated: 2012-02-28
Results Overview
Clinician-administered 43-item assessment to evaluate discontinuation-emergent symptoms resulting from withdrawal from study treatment. Total score=sum of number of new symptoms and old (but worse) symptoms (score=1) and old and unchanged symptom, absent, or old symptom but improved (score=0); total possible range 0 to 43. Higher score=more symptoms. New symptom=any symptom that appeared within 7 days before DESS administration; old symptom=any symptom that appeared 7 days before DESS administration and continued into 7-day period. DESS calculated as 2\*mean(of DESSDB Week 1, DESSDB Week 2).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
480 participants
Primary outcome timeframe
Double-blind phase: Week 1 (Study Day 175), Week 2 (Study Day 182)
Results posted on
2012-02-28
Participant Flow
Eligible participants entered a 24 Week Open-label treatment phase; participants who completed the Open-label phase were randomized to a 4 Week Double-blind treatment phase.
Participant milestones
| Measure |
DVS SR 50 mg (Open-label Phase)
Desvenlafaxine Succinate Sustained-Release Formulation (DVS SR) 50 milligrams (mg) by mouth (PO) once daily (QD) for 24 Weeks.
|
DVS SR 50 mg (Double-blind Phase)
DVS SR 50 mg (reference group): 2 tablets PO once daily (QD) for 1 week (1 tablet DVS SR 50 mg and 1 tablet placebo 25 mg) then DVS SR 50 mg 1 tablet PO QD Weeks 2 through 4.
|
DVS SR 25 mg (Double-blind Phase)
DVS SR 25 mg (taper group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet DVS SR 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4.
|
Placebo (Double-blind Phase)
Placebo (abrupt-discontinuation group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet placebo 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4.
|
|---|---|---|---|---|
|
Open-label Phase
STARTED
|
480
|
0
|
0
|
0
|
|
Open-label Phase
COMPLETED
|
361
|
0
|
0
|
0
|
|
Open-label Phase
NOT COMPLETED
|
119
|
0
|
0
|
0
|
|
Double-blind Phase
STARTED
|
0
|
73
|
140
|
148
|
|
Double-blind Phase
COMPLETED
|
0
|
69
|
127
|
138
|
|
Double-blind Phase
NOT COMPLETED
|
0
|
4
|
13
|
10
|
Reasons for withdrawal
| Measure |
DVS SR 50 mg (Open-label Phase)
Desvenlafaxine Succinate Sustained-Release Formulation (DVS SR) 50 milligrams (mg) by mouth (PO) once daily (QD) for 24 Weeks.
|
DVS SR 50 mg (Double-blind Phase)
DVS SR 50 mg (reference group): 2 tablets PO once daily (QD) for 1 week (1 tablet DVS SR 50 mg and 1 tablet placebo 25 mg) then DVS SR 50 mg 1 tablet PO QD Weeks 2 through 4.
|
DVS SR 25 mg (Double-blind Phase)
DVS SR 25 mg (taper group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet DVS SR 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4.
|
Placebo (Double-blind Phase)
Placebo (abrupt-discontinuation group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet placebo 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4.
|
|---|---|---|---|---|
|
Open-label Phase
Adverse Event
|
29
|
0
|
0
|
0
|
|
Open-label Phase
Lost to Follow-up
|
30
|
0
|
0
|
0
|
|
Open-label Phase
Other
|
9
|
0
|
0
|
0
|
|
Open-label Phase
Protocol Violation
|
6
|
0
|
0
|
0
|
|
Open-label Phase
Withdrawal by Subject
|
26
|
0
|
0
|
0
|
|
Open-label Phase
Lack of Efficacy
|
18
|
0
|
0
|
0
|
|
Open-label Phase
Not randomized to Double-blind phase
|
1
|
0
|
0
|
0
|
|
Double-blind Phase
Adverse Event
|
0
|
1
|
2
|
1
|
|
Double-blind Phase
Lost to Follow-up
|
0
|
2
|
2
|
2
|
|
Double-blind Phase
Other
|
0
|
0
|
1
|
2
|
|
Double-blind Phase
Protocol Violation
|
0
|
0
|
1
|
1
|
|
Double-blind Phase
Withdrawal by Subject
|
0
|
0
|
4
|
2
|
|
Double-blind Phase
Discontinuation symptom
|
0
|
1
|
2
|
2
|
|
Double-blind Phase
Physician Decision
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Study Comparing Discontinuation Symptoms Of DVS SR In Subjects With Major Depressive Disorder (MDD)
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=480 Participants
24 Week Open-label phase DVS SR 50 mg PO QD followed by 4 Week Double-blind phase: DVS SR 50 mg (reference group), DVS SR 25 mg (taper group), or Placebo (abrupt-discontinuation group).
|
|---|---|
|
Age Continuous
|
46.5 years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
330 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
150 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Double-blind phase: Week 1 (Study Day 175), Week 2 (Study Day 182)Population: Full Analysis Set (FAS): all randomized participants who had at least 1 postrandomization DESS record. Mean was adjusted for baseline DESS score and study center.
Clinician-administered 43-item assessment to evaluate discontinuation-emergent symptoms resulting from withdrawal from study treatment. Total score=sum of number of new symptoms and old (but worse) symptoms (score=1) and old and unchanged symptom, absent, or old symptom but improved (score=0); total possible range 0 to 43. Higher score=more symptoms. New symptom=any symptom that appeared within 7 days before DESS administration; old symptom=any symptom that appeared 7 days before DESS administration and continued into 7-day period. DESS calculated as 2\*mean(of DESSDB Week 1, DESSDB Week 2).
Outcome measures
| Measure |
DVS SR 50 mg
n=72 Participants
DVS SR 50 mg (reference group): 2 tablets PO once daily (QD) for 1 week (1 tablet DVS SR 50 mg and 1 tablet placebo 25 mg) then DVS SR 50 mg 1 tablet PO QD Weeks 2 through 4.
|
DVS SR 25 mg
n=139 Participants
DVS SR 25 mg (taper group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet DVS SR 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4.
|
Placebo
n=146 Participants
Placebo (abrupt-discontinuation group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet placebo 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4.
|
|---|---|---|---|
|
Total Discontinuation - Emergent Signs and Symptoms (DESS) Score Over the First 2 Weeks of the Double-blind Phase
|
4.1 scores on a scale
Standard Error 0.72
|
4.8 scores on a scale
Standard Error 0.54
|
5.3 scores on a scale
Standard Error 0.52
|
SECONDARY outcome
Timeframe: Double-blind phase: Baseline (Study Day 168) up to Week 4 (Study Day 196)Population: Safety population (Double-blind phase): all participants who received at least 1 dose of study treatment and were randomized into the Double-blind treatment phase.
Any untoward medical occurrence in a patient who received study drug was considered an AE without regard to possibility of causal relationship. Taper-emergent AEs (TPAEs) are those events which occurred during the double-blind period but did not occur during the last 7 days of the on-therapy period or existed during the last 7 days and worsened in the double-blind period.
Outcome measures
| Measure |
DVS SR 50 mg
n=73 Participants
DVS SR 50 mg (reference group): 2 tablets PO once daily (QD) for 1 week (1 tablet DVS SR 50 mg and 1 tablet placebo 25 mg) then DVS SR 50 mg 1 tablet PO QD Weeks 2 through 4.
|
DVS SR 25 mg
n=140 Participants
DVS SR 25 mg (taper group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet DVS SR 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4.
|
Placebo
n=148 Participants
Placebo (abrupt-discontinuation group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet placebo 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4.
|
|---|---|---|---|
|
Percentage of Participants With Taper Adverse Events (AEs) in the Double-blind Phase
|
35.6 percentage of participants
|
38.6 percentage of participants
|
50.7 percentage of participants
|
SECONDARY outcome
Timeframe: Double-blind phase: Baseline (Study Day 168) up to Week 4 (Study Day 196)Population: Safety population
Discontinuation symptoms may occur following abrupt cessation of serotonergic antidepressants in a minority of participants following short-term treatment of an episode of Major Depressive Disorder (MDD). The symptoms include emotional and somatic symptoms such as dizziness, nausea, and paresthesia and typically appear within 2 to 3 days of reducing the dose or stopping the antidepressant medication. Discontinuation symptoms are usually mild and resolve spontaneously within a week in the majority of patients, though a minority can have intense and prolonged symptoms.
Outcome measures
| Measure |
DVS SR 50 mg
n=72 Participants
DVS SR 50 mg (reference group): 2 tablets PO once daily (QD) for 1 week (1 tablet DVS SR 50 mg and 1 tablet placebo 25 mg) then DVS SR 50 mg 1 tablet PO QD Weeks 2 through 4.
|
DVS SR 25 mg
n=139 Participants
DVS SR 25 mg (taper group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet DVS SR 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4.
|
Placebo
n=146 Participants
Placebo (abrupt-discontinuation group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet placebo 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4.
|
|---|---|---|---|
|
Percentage of Participants Who Were Unable to Successfully Complete Tapering of the Study Drug Because of the Number and/or Severity of Their Discontinuation Symptoms
|
1.4 percentage of participants
|
1.4 percentage of participants
|
1.4 percentage of participants
|
Adverse Events
DVS SR 50 mg (Open-label Phase)
Serious events: 5 serious events
Other events: 197 other events
Deaths: 0 deaths
DVS SR 50 mg (Double-blind Phase)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
DVS SR 25 mg (Double-blind Phase)
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Placebo (Double-blind Phase)
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DVS SR 50 mg (Open-label Phase)
n=480 participants at risk
DVS SR 50 mg PO QD for 24 Weeks.
|
DVS SR 50 mg (Double-blind Phase)
n=73 participants at risk
DVS SR 50 mg (reference group): 2 tablets PO once daily (QD) for 1 week (1 tablet DVS SR 50 mg and 1 tablet placebo 25 mg) then DVS SR 50 mg 1 tablet PO QD Weeks 2 through 4.
|
DVS SR 25 mg (Double-blind Phase)
n=140 participants at risk
DVS SR 25 mg (taper group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet DVS SR 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4.
|
Placebo (Double-blind Phase)
n=148 participants at risk
Placebo (abrupt-discontinuation group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet placebo 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4.
|
|---|---|---|---|---|
|
Cardiac disorders
Coronary artery disease
|
0.21%
1/480 • Events collected from the signing of the informed consent form up to 14 days after the last dose of study treatment
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/73 • Events collected from the signing of the informed consent form up to 14 days after the last dose of study treatment
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/140 • Events collected from the signing of the informed consent form up to 14 days after the last dose of study treatment
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/148 • Events collected from the signing of the informed consent form up to 14 days after the last dose of study treatment
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.21%
1/480 • Events collected from the signing of the informed consent form up to 14 days after the last dose of study treatment
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/73 • Events collected from the signing of the informed consent form up to 14 days after the last dose of study treatment
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/140 • Events collected from the signing of the informed consent form up to 14 days after the last dose of study treatment
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/148 • Events collected from the signing of the informed consent form up to 14 days after the last dose of study treatment
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.21%
1/480 • Events collected from the signing of the informed consent form up to 14 days after the last dose of study treatment
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/73 • Events collected from the signing of the informed consent form up to 14 days after the last dose of study treatment
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/140 • Events collected from the signing of the informed consent form up to 14 days after the last dose of study treatment
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/148 • Events collected from the signing of the informed consent form up to 14 days after the last dose of study treatment
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.21%
1/480 • Events collected from the signing of the informed consent form up to 14 days after the last dose of study treatment
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/73 • Events collected from the signing of the informed consent form up to 14 days after the last dose of study treatment
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/140 • Events collected from the signing of the informed consent form up to 14 days after the last dose of study treatment
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/148 • Events collected from the signing of the informed consent form up to 14 days after the last dose of study treatment
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Intentional self-injury
|
0.21%
1/480 • Events collected from the signing of the informed consent form up to 14 days after the last dose of study treatment
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/73 • Events collected from the signing of the informed consent form up to 14 days after the last dose of study treatment
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/140 • Events collected from the signing of the informed consent form up to 14 days after the last dose of study treatment
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/148 • Events collected from the signing of the informed consent form up to 14 days after the last dose of study treatment
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Suicidal ideation
|
0.21%
1/480 • Events collected from the signing of the informed consent form up to 14 days after the last dose of study treatment
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/73 • Events collected from the signing of the informed consent form up to 14 days after the last dose of study treatment
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/140 • Events collected from the signing of the informed consent form up to 14 days after the last dose of study treatment
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/148 • Events collected from the signing of the informed consent form up to 14 days after the last dose of study treatment
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.21%
1/480 • Events collected from the signing of the informed consent form up to 14 days after the last dose of study treatment
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/73 • Events collected from the signing of the informed consent form up to 14 days after the last dose of study treatment
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/140 • Events collected from the signing of the informed consent form up to 14 days after the last dose of study treatment
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/148 • Events collected from the signing of the informed consent form up to 14 days after the last dose of study treatment
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
DVS SR 50 mg (Open-label Phase)
n=480 participants at risk
DVS SR 50 mg PO QD for 24 Weeks.
|
DVS SR 50 mg (Double-blind Phase)
n=73 participants at risk
DVS SR 50 mg (reference group): 2 tablets PO once daily (QD) for 1 week (1 tablet DVS SR 50 mg and 1 tablet placebo 25 mg) then DVS SR 50 mg 1 tablet PO QD Weeks 2 through 4.
|
DVS SR 25 mg (Double-blind Phase)
n=140 participants at risk
DVS SR 25 mg (taper group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet DVS SR 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4.
|
Placebo (Double-blind Phase)
n=148 participants at risk
Placebo (abrupt-discontinuation group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet placebo 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.2%
25/480 • Events collected from the signing of the informed consent form up to 14 days after the last dose of study treatment
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/73 • Events collected from the signing of the informed consent form up to 14 days after the last dose of study treatment
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/140 • Events collected from the signing of the informed consent form up to 14 days after the last dose of study treatment
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/148 • Events collected from the signing of the informed consent form up to 14 days after the last dose of study treatment
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Dry mouth
|
5.8%
28/480 • Events collected from the signing of the informed consent form up to 14 days after the last dose of study treatment
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/73 • Events collected from the signing of the informed consent form up to 14 days after the last dose of study treatment
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/140 • Events collected from the signing of the informed consent form up to 14 days after the last dose of study treatment
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/148 • Events collected from the signing of the informed consent form up to 14 days after the last dose of study treatment
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
13.3%
64/480 • Events collected from the signing of the informed consent form up to 14 days after the last dose of study treatment
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.8%
5/73 • Events collected from the signing of the informed consent form up to 14 days after the last dose of study treatment
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
6/140 • Events collected from the signing of the informed consent form up to 14 days after the last dose of study treatment
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.1%
9/148 • Events collected from the signing of the informed consent form up to 14 days after the last dose of study treatment
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Fatigue
|
5.0%
24/480 • Events collected from the signing of the informed consent form up to 14 days after the last dose of study treatment
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/73 • Events collected from the signing of the informed consent form up to 14 days after the last dose of study treatment
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/140 • Events collected from the signing of the informed consent form up to 14 days after the last dose of study treatment
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/148 • Events collected from the signing of the informed consent form up to 14 days after the last dose of study treatment
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.2%
25/480 • Events collected from the signing of the informed consent form up to 14 days after the last dose of study treatment
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/73 • Events collected from the signing of the informed consent form up to 14 days after the last dose of study treatment
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/140 • Events collected from the signing of the informed consent form up to 14 days after the last dose of study treatment
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/148 • Events collected from the signing of the informed consent form up to 14 days after the last dose of study treatment
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dizziness
|
8.1%
39/480 • Events collected from the signing of the informed consent form up to 14 days after the last dose of study treatment
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.4%
1/73 • Events collected from the signing of the informed consent form up to 14 days after the last dose of study treatment
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.7%
8/140 • Events collected from the signing of the informed consent form up to 14 days after the last dose of study treatment
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
9.5%
14/148 • Events collected from the signing of the informed consent form up to 14 days after the last dose of study treatment
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
10.8%
52/480 • Events collected from the signing of the informed consent form up to 14 days after the last dose of study treatment
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.1%
3/73 • Events collected from the signing of the informed consent form up to 14 days after the last dose of study treatment
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
7.1%
10/140 • Events collected from the signing of the informed consent form up to 14 days after the last dose of study treatment
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
13.5%
20/148 • Events collected from the signing of the informed consent form up to 14 days after the last dose of study treatment
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Insomnia
|
7.9%
38/480 • Events collected from the signing of the informed consent form up to 14 days after the last dose of study treatment
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/73 • Events collected from the signing of the informed consent form up to 14 days after the last dose of study treatment
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/140 • Events collected from the signing of the informed consent form up to 14 days after the last dose of study treatment
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/148 • Events collected from the signing of the informed consent form up to 14 days after the last dose of study treatment
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
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