Trial Outcomes & Findings for Drug Use Investigation of Jzoloft. (NCT NCT00605865)
NCT ID: NCT00605865
Last Updated: 2021-01-28
Results Overview
All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product.
Recruitment status
COMPLETED
Target enrollment
2272 participants
Primary outcome timeframe
Baseline up to 16 weeks
Results posted on
2021-01-28
Participant Flow
Participant milestones
| Measure |
Sertraline
Participants taking Sertraline according to Japanese Package Insert
|
|---|---|
|
Overall Study
STARTED
|
2272
|
|
Overall Study
COMPLETED
|
2157
|
|
Overall Study
NOT COMPLETED
|
115
|
Reasons for withdrawal
| Measure |
Sertraline
Participants taking Sertraline according to Japanese Package Insert
|
|---|---|
|
Overall Study
Protocol Violation
|
115
|
Baseline Characteristics
Drug Use Investigation of Jzoloft.
Baseline characteristics by cohort
| Measure |
Sertraline
n=2157 Participants
Participants taking Sertraline according to Japanese Package Insert
|
|---|---|
|
Age, Customized
<65 years
|
1820 participants
n=5 Participants
|
|
Age, Customized
>=65 years
|
337 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1289 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
868 Participants
n=5 Participants
|
|
Target Disease
Depression/Depressed State
|
1870 participants
n=5 Participants
|
|
Target Disease
Panic Disorder
|
150 participants
n=5 Participants
|
|
Target Disease
Depression/Depressed state and Panic Disorder
|
56 participants
n=5 Participants
|
|
Target Disease
Other than Those Above
|
81 participants
n=5 Participants
|
|
Target Disease Severity
Mild
|
568 participants
n=5 Participants
|
|
Target Disease Severity
Moderate
|
1423 participants
n=5 Participants
|
|
Target Disease Severity
Severe
|
166 participants
n=5 Participants
|
|
Complications
Present
|
777 participants
n=5 Participants
|
|
Complications
Absent
|
1380 participants
n=5 Participants
|
|
Concomitant Drug
Present
|
1874 participants
n=5 Participants
|
|
Concomitant Drug
Absent
|
283 participants
n=5 Participants
|
|
Starting Dose
25 mg
|
1530 participants
n=5 Participants
|
|
Starting Dose
50 mg
|
523 participants
n=5 Participants
|
|
Starting Dose
75 mg
|
33 participants
n=5 Participants
|
|
Starting Dose
100 mg
|
31 participants
n=5 Participants
|
|
Starting Dose
Other than Those Above
|
40 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 16 weeksPopulation: Safety analysis population included all enrolled participants who had received at least 1 confirmed administration of Sertraline.
All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product.
Outcome measures
| Measure |
Sertraline
n=2157 Participants
Participants who took Sertraline according to Japanese Package Insert
|
Without Complications
Participants without complications who took Sertraline according to Japanese Package Insert
|
>=50mg, <75mg
Participants who took more than 50mg and less than 75mg of Sertraline a day on average according to Japanese Package Insert
|
>=75mg, <100mg
Participants who took more than 75mg and less than 100mg of Sertraline a day on average according to Japanese Package Insert
|
>=100mg
Participants who took more than 100mg of Sertraline a day on average according to Japanese Package Insert
|
|---|---|---|---|---|---|
|
Number of Participants of Treatment Related Adverse Events (TRAEs)
|
263 participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline up to 16 weeksPopulation: The safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed.
Outcome measures
| Measure |
Sertraline
n=2157 Participants
Participants who took Sertraline according to Japanese Package Insert
|
Without Complications
Participants without complications who took Sertraline according to Japanese Package Insert
|
>=50mg, <75mg
Participants who took more than 50mg and less than 75mg of Sertraline a day on average according to Japanese Package Insert
|
>=75mg, <100mg
Participants who took more than 75mg and less than 100mg of Sertraline a day on average according to Japanese Package Insert
|
>=100mg
Participants who took more than 100mg of Sertraline a day on average according to Japanese Package Insert
|
|---|---|---|---|---|---|
|
Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert
Gastritis
|
3 events
|
—
|
—
|
—
|
—
|
|
Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert
Dyspnoea
|
3 events
|
—
|
—
|
—
|
—
|
|
Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert
Sedation
|
2 events
|
—
|
—
|
—
|
—
|
|
Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert
Erectile dysfunction
|
2 events
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 16 weeksPopulation: The safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed.
Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without complications is significant risk factor, Complications is the patient's current experiences with illnesses, operations, injuries and treatments. The physician of this survey made the diagnosis. (e.g. hypertension, diabetes, etc.)
Outcome measures
| Measure |
Sertraline
n=777 Participants
Participants who took Sertraline according to Japanese Package Insert
|
Without Complications
n=1380 Participants
Participants without complications who took Sertraline according to Japanese Package Insert
|
>=50mg, <75mg
Participants who took more than 50mg and less than 75mg of Sertraline a day on average according to Japanese Package Insert
|
>=75mg, <100mg
Participants who took more than 75mg and less than 100mg of Sertraline a day on average according to Japanese Package Insert
|
>=100mg
Participants who took more than 100mg of Sertraline a day on average according to Japanese Package Insert
|
|---|---|---|---|---|---|
|
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Complications
|
129 participants
|
134 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 16 weeksPopulation: The safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed.
Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without concomitant drug is significant risk factor, Concomitant drugs is the drugs which participant had taken during the observation period of this study to treat for participant's illnesses, injuries etc. The physician of this survey listed all of concomitant drugs. (e.g. paroxetine, milnacipran, etc.)
Outcome measures
| Measure |
Sertraline
n=1864 Participants
Participants who took Sertraline according to Japanese Package Insert
|
Without Complications
n=293 Participants
Participants without complications who took Sertraline according to Japanese Package Insert
|
>=50mg, <75mg
Participants who took more than 50mg and less than 75mg of Sertraline a day on average according to Japanese Package Insert
|
>=75mg, <100mg
Participants who took more than 75mg and less than 100mg of Sertraline a day on average according to Japanese Package Insert
|
>=100mg
Participants who took more than 100mg of Sertraline a day on average according to Japanese Package Insert
|
|---|---|---|---|---|---|
|
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Concomitant Drug
|
238 participants
|
25 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 16 weeksPopulation: The safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed.
Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without renal dysfunction is significant risk factor
Outcome measures
| Measure |
Sertraline
n=24 Participants
Participants who took Sertraline according to Japanese Package Insert
|
Without Complications
n=2133 Participants
Participants without complications who took Sertraline according to Japanese Package Insert
|
>=50mg, <75mg
Participants who took more than 50mg and less than 75mg of Sertraline a day on average according to Japanese Package Insert
|
>=75mg, <100mg
Participants who took more than 75mg and less than 100mg of Sertraline a day on average according to Japanese Package Insert
|
>=100mg
Participants who took more than 100mg of Sertraline a day on average according to Japanese Package Insert
|
|---|---|---|---|---|---|
|
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Renal Dysfunction
|
7 participants
|
256 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 16 weeksPopulation: The safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed.
Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without Past Medical History of Other Illness is significant risk factor
Outcome measures
| Measure |
Sertraline
n=349 Participants
Participants who took Sertraline according to Japanese Package Insert
|
Without Complications
n=1808 Participants
Participants without complications who took Sertraline according to Japanese Package Insert
|
>=50mg, <75mg
Participants who took more than 50mg and less than 75mg of Sertraline a day on average according to Japanese Package Insert
|
>=75mg, <100mg
Participants who took more than 75mg and less than 100mg of Sertraline a day on average according to Japanese Package Insert
|
>=100mg
Participants who took more than 100mg of Sertraline a day on average according to Japanese Package Insert
|
|---|---|---|---|---|---|
|
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Past Medical History of Other Illness
|
57 participants
|
206 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 16 weeksPopulation: The safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed.
Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether average daily dose is significant risk factor
Outcome measures
| Measure |
Sertraline
n=28 Participants
Participants who took Sertraline according to Japanese Package Insert
|
Without Complications
n=1049 Participants
Participants without complications who took Sertraline according to Japanese Package Insert
|
>=50mg, <75mg
n=590 Participants
Participants who took more than 50mg and less than 75mg of Sertraline a day on average according to Japanese Package Insert
|
>=75mg, <100mg
n=455 Participants
Participants who took more than 75mg and less than 100mg of Sertraline a day on average according to Japanese Package Insert
|
>=100mg
n=35 Participants
Participants who took more than 100mg of Sertraline a day on average according to Japanese Package Insert
|
|---|---|---|---|---|---|
|
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Average Daily Dose
|
6 participants
|
175 participants
|
61 participants
|
20 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline up to 16 weeksPopulation: The safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed.
Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without suicidal ideation (including suicide attempt) is significant risk factor
Outcome measures
| Measure |
Sertraline
n=469 Participants
Participants who took Sertraline according to Japanese Package Insert
|
Without Complications
n=1608 Participants
Participants without complications who took Sertraline according to Japanese Package Insert
|
>=50mg, <75mg
Participants who took more than 50mg and less than 75mg of Sertraline a day on average according to Japanese Package Insert
|
>=75mg, <100mg
Participants who took more than 75mg and less than 100mg of Sertraline a day on average according to Japanese Package Insert
|
>=100mg
Participants who took more than 100mg of Sertraline a day on average according to Japanese Package Insert
|
|---|---|---|---|---|---|
|
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Suicidal Ideation (Including Suicide Attempt)
|
73 participants
|
182 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 16 weeksPopulation: The safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed.
Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether 15 years and higher of age or not is significant risk factor
Outcome measures
| Measure |
Sertraline
n=2153 Participants
Participants who took Sertraline according to Japanese Package Insert
|
Without Complications
n=4 Participants
Participants without complications who took Sertraline according to Japanese Package Insert
|
>=50mg, <75mg
Participants who took more than 50mg and less than 75mg of Sertraline a day on average according to Japanese Package Insert
|
>=75mg, <100mg
Participants who took more than 75mg and less than 100mg of Sertraline a day on average according to Japanese Package Insert
|
>=100mg
Participants who took more than 100mg of Sertraline a day on average according to Japanese Package Insert
|
|---|---|---|---|---|---|
|
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: 15 Years and Higher of Age or Not
|
261 participants
|
2 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 16 weeksPopulation: The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).
Number of participants with responders of Sertraline to determine whether target disease severity is significant factor
Outcome measures
| Measure |
Sertraline
n=478 Participants
Participants who took Sertraline according to Japanese Package Insert
|
Without Complications
n=1160 Participants
Participants without complications who took Sertraline according to Japanese Package Insert
|
>=50mg, <75mg
n=127 Participants
Participants who took more than 50mg and less than 75mg of Sertraline a day on average according to Japanese Package Insert
|
>=75mg, <100mg
Participants who took more than 75mg and less than 100mg of Sertraline a day on average according to Japanese Package Insert
|
>=100mg
Participants who took more than 100mg of Sertraline a day on average according to Japanese Package Insert
|
|---|---|---|---|---|---|
|
Factors Considered to Affect the Efficacy of Sertraline: Target Disease Severity
|
416 participants
|
1000 participants
|
93 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 16 weeksPopulation: The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).
Number of participants with responders of Sertraline to determine whether with or without history of treatment prior to administration of Sertraline hydrochloride is significant factor
Outcome measures
| Measure |
Sertraline
n=489 Participants
Participants who took Sertraline according to Japanese Package Insert
|
Without Complications
n=1202 Participants
Participants without complications who took Sertraline according to Japanese Package Insert
|
>=50mg, <75mg
Participants who took more than 50mg and less than 75mg of Sertraline a day on average according to Japanese Package Insert
|
>=75mg, <100mg
Participants who took more than 75mg and less than 100mg of Sertraline a day on average according to Japanese Package Insert
|
>=100mg
Participants who took more than 100mg of Sertraline a day on average according to Japanese Package Insert
|
|---|---|---|---|---|---|
|
Factors Considered to Affect the Efficacy of Sertraline: History of Treatment Prior to Administration of Sertraline Hydrochloride
|
398 participants
|
1046 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 16 weeksPopulation: The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).
Number of participants with responders of Sertraline to determine whether outpatient or inpatient is significant factor
Outcome measures
| Measure |
Sertraline
n=127 Participants
Participants who took Sertraline according to Japanese Package Insert
|
Without Complications
n=1638 Participants
Participants without complications who took Sertraline according to Japanese Package Insert
|
>=50mg, <75mg
Participants who took more than 50mg and less than 75mg of Sertraline a day on average according to Japanese Package Insert
|
>=75mg, <100mg
Participants who took more than 75mg and less than 100mg of Sertraline a day on average according to Japanese Package Insert
|
>=100mg
Participants who took more than 100mg of Sertraline a day on average according to Japanese Package Insert
|
|---|---|---|---|---|---|
|
Factors Considered to Affect the Efficacy of Sertraline: Outpatient/Inpatient
|
99 participants
|
1410 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 16 weeksPopulation: The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).
Number of participants with responders of Sertraline to determine whether with or without complication is significant factor
Outcome measures
| Measure |
Sertraline
n=637 Participants
Participants who took Sertraline according to Japanese Package Insert
|
Without Complications
n=1128 Participants
Participants without complications who took Sertraline according to Japanese Package Insert
|
>=50mg, <75mg
Participants who took more than 50mg and less than 75mg of Sertraline a day on average according to Japanese Package Insert
|
>=75mg, <100mg
Participants who took more than 75mg and less than 100mg of Sertraline a day on average according to Japanese Package Insert
|
>=100mg
Participants who took more than 100mg of Sertraline a day on average according to Japanese Package Insert
|
|---|---|---|---|---|---|
|
Factors Considered to Affect the Efficacy of Sertraline: Complication ;Complications is the Patient's Current Experiences With Illnesses, Operations, Injuries and Treatments.
|
528 participants
|
981 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 16 weeksPopulation: The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).
Number of participants with responders of Sertraline to determine whether 15 years and higher of age or not is significant factor
Outcome measures
| Measure |
Sertraline
n=1762 Participants
Participants who took Sertraline according to Japanese Package Insert
|
Without Complications
n=3 Participants
Participants without complications who took Sertraline according to Japanese Package Insert
|
>=50mg, <75mg
Participants who took more than 50mg and less than 75mg of Sertraline a day on average according to Japanese Package Insert
|
>=75mg, <100mg
Participants who took more than 75mg and less than 100mg of Sertraline a day on average according to Japanese Package Insert
|
>=100mg
Participants who took more than 100mg of Sertraline a day on average according to Japanese Package Insert
|
|---|---|---|---|---|---|
|
Factors Considered to Affect the Efficacy of Sertraline: 15 Years and Higher of Age or Not
|
1508 participants
|
1 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 16 weeksPopulation: The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).
Number of participants with responders of Sertraline to determine whether age is significant factor
Outcome measures
| Measure |
Sertraline
n=34 Participants
Participants who took Sertraline according to Japanese Package Insert
|
Without Complications
n=955 Participants
Participants without complications who took Sertraline according to Japanese Package Insert
|
>=50mg, <75mg
n=487 Participants
Participants who took more than 50mg and less than 75mg of Sertraline a day on average according to Japanese Package Insert
|
>=75mg, <100mg
n=289 Participants
Participants who took more than 75mg and less than 100mg of Sertraline a day on average according to Japanese Package Insert
|
>=100mg
Participants who took more than 100mg of Sertraline a day on average according to Japanese Package Insert
|
|---|---|---|---|---|---|
|
Factors Considered to Affect the Efficacy of Sertraline: Age
|
23 participants
|
829 participants
|
412 participants
|
245 participants
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 16 weeksPopulation: The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).
Number of participants with responders of Sertraline to determine whether with or without suicidal ideation (including suicide attempt) is significant factor
Outcome measures
| Measure |
Sertraline
n=397 Participants
Participants who took Sertraline according to Japanese Package Insert
|
Without Complications
n=1303 Participants
Participants without complications who took Sertraline according to Japanese Package Insert
|
>=50mg, <75mg
Participants who took more than 50mg and less than 75mg of Sertraline a day on average according to Japanese Package Insert
|
>=75mg, <100mg
Participants who took more than 75mg and less than 100mg of Sertraline a day on average according to Japanese Package Insert
|
>=100mg
Participants who took more than 100mg of Sertraline a day on average according to Japanese Package Insert
|
|---|---|---|---|---|---|
|
Factors Considered to Affect the Efficacy of Sertraline: Suicidal Ideation (Including Suicide Attempt)
|
319 participants
|
1136 participants
|
—
|
—
|
—
|
Adverse Events
Sertraline
Serious events: 9 serious events
Other events: 263 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sertraline
n=2157 participants at risk
Participants taking Sertraline according to Japanese Package Insert. All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product.
|
|---|---|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.05%
1/2157 • Number of events 1
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
Dissociative disorder
|
0.05%
1/2157 • Number of events 1
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
Completed suicide
|
0.05%
1/2157 • Number of events 1
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
|
0.05%
1/2157 • Number of events 1
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
Serotonin syndrome
|
0.05%
1/2157 • Number of events 1
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
Neuroleptic malignant syndrome
|
0.05%
1/2157 • Number of events 1
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
Extrapyramidal disorder
|
0.05%
1/2157 • Number of events 1
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.
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.05%
1/2157 • Number of events 1
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
Irritability
|
0.05%
1/2157 • Number of events 1
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.
|
|
Injury, poisoning and procedural complications
Fall
|
0.05%
1/2157 • Number of events 1
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 |
Sertraline
n=2157 participants at risk
Participants taking Sertraline according to Japanese Package Insert. All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product.
|
|---|---|
|
Nervous system disorders
Tremor
|
0.23%
5/2157 • Number of events 5
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
Anxiety
|
0.19%
4/2157 • Number of events 4
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.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.19%
4/2157 • Number of events 4
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
Feeling abnormal
|
0.19%
4/2157 • Number of events 4
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
Extrapyramidal disorder
|
0.14%
3/2157 • Number of events 3
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
|
0.14%
3/2157 • Number of events 3
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
Gastritis
|
0.14%
3/2157 • Number of events 3
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.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.14%
3/2157 • Number of events 3
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.
|
|
Renal and urinary disorders
Dysuria
|
0.14%
3/2157 • Number of events 3
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.
|
|
Reproductive system and breast disorders
Ejaculation delayed
|
0.14%
3/2157 • Number of events 3
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
Chest discomfort
|
0.14%
3/2157 • Number of events 3
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
|
0.09%
2/2157 • Number of events 2
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
Akathisia
|
0.09%
2/2157 • Number of events 2
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
Serotonin syndrome
|
0.09%
2/2157 • Number of events 2
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
Sedation
|
0.09%
2/2157 • Number of events 2
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.
|
|
Vascular disorders
Hypotension
|
0.09%
2/2157 • Number of events 2
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
Abdominal pain upper
|
0.09%
2/2157 • Number of events 2
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
Vomiting
|
0.09%
2/2157 • Number of events 2
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.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.09%
2/2157 • Number of events 2
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.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.09%
2/2157 • Number of events 2
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.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.09%
2/2157 • Number of events 2
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
Thirst
|
0.09%
2/2157 • Number of events 2
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.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.05%
1/2157 • Number of events 1
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
Increased appetite
|
0.05%
1/2157 • Number of events 1
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
Activation syndrome
|
0.05%
1/2157 • Number of events 1
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
Libido decreased
|
0.05%
1/2157 • Number of events 1
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
Dissociative disorder
|
0.05%
1/2157 • Number of events 1
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
Mood altered
|
0.05%
1/2157 • Number of events 1
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
Agitation
|
0.05%
1/2157 • Number of events 1
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
Hallucination
|
0.05%
1/2157 • Number of events 1
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
Hallucination, visual
|
0.05%
1/2157 • Number of events 1
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
Hallucination, auditory
|
0.05%
1/2157 • Number of events 1
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
|
0.05%
1/2157 • Number of events 1
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
Completed suicide
|
0.05%
1/2157 • Number of events 1
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
|
0.05%
1/2157 • Number of events 1
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
Euphoric mood
|
0.05%
1/2157 • Number of events 1
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
Delusion
|
0.05%
1/2157 • Number of events 1
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
Restlessness
|
0.05%
1/2157 • Number of events 1
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
Withdrawal syndrome
|
0.05%
1/2157 • Number of events 1
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
Parkinson's disease
|
0.05%
1/2157 • Number of events 1
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
Neuroleptic malignant syndrome
|
0.05%
1/2157 • Number of events 1
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
Dysaesthesia
|
0.05%
1/2157 • Number of events 1
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
Hypoaesthesia
|
0.05%
1/2157 • Number of events 1
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
Dysstasia
|
0.05%
1/2157 • Number of events 1
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
Autonomic nervous system imbalance
|
0.05%
1/2157 • Number of events 1
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
Psychomotor hyperactivity
|
0.05%
1/2157 • Number of events 1
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.
|
|
Vascular disorders
Orthostatic hypotension
|
0.05%
1/2157 • Number of events 1
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
Gastrointestinal disorder
|
0.05%
1/2157 • Number of events 1
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
Dyspepsia
|
0.05%
1/2157 • Number of events 1
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
Abdominal pain
|
0.05%
1/2157 • Number of events 1
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
Salivary hypersecretion
|
0.05%
1/2157 • Number of events 1
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.
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.05%
1/2157 • Number of events 1
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.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.05%
1/2157 • Number of events 1
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.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.05%
1/2157 • Number of events 1
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.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.05%
1/2157 • Number of events 1
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.
|
|
Reproductive system and breast disorders
Sexual dysfunction
|
0.05%
1/2157 • Number of events 1
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.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.05%
1/2157 • Number of events 1
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.
|
|
Investigations
Hepatic enzyme increased
|
0.05%
1/2157 • Number of events 1
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.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.05%
1/2157 • Number of events 1
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.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.05%
1/2157 • Number of events 1
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.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.05%
1/2157 • Number of events 1
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.
|
|
Investigations
Weight increased
|
0.05%
1/2157 • Number of events 1
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.
|
|
Injury, poisoning and procedural complications
Fall
|
0.05%
1/2157 • Number of events 1
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
|
4.0%
87/2157 • Number of events 87
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
Diarrhoea
|
1.3%
27/2157 • Number of events 27
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
Somnolence
|
1.1%
23/2157 • Number of events 23
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
Constipation
|
0.97%
21/2157 • Number of events 21
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
|
0.51%
11/2157 • Number of events 11
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
Mania
|
0.46%
10/2157 • Number of events 10
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
Malaise
|
0.42%
9/2157 • Number of events 9
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
|
0.37%
8/2157 • Number of events 8
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
|
0.37%
8/2157 • Number of events 8
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
Irritability
|
0.37%
8/2157 • Number of events 8
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
Abdominal discomfort
|
0.32%
7/2157 • Number of events 7
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.
|
|
Cardiac disorders
Palpitations
|
0.28%
6/2157 • Number of events 6
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