Trial Outcomes & Findings for Special Investigation Of J Zoloft For Panic Disorder Patients (NCT NCT00605917)

NCT ID: NCT00605917

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: 997 participants
• Primary outcome timeframe: Baseline up to 52 weeks
• Results posted on: 2021-01-28

Participant Flow

Participant milestones

Measure	Sertraline Participants taking Sertraline according to Japanese Package Insert; This study is Special Investigation of JZOLOFT for panic disorder and one of conditions of this study is "patients who are diagnosed with panic disorder". So, all of participants in this study are panic disorder patients.
Overall Study STARTED	987
Overall Study COMPLETED	908
Overall Study NOT COMPLETED	79

Reasons for withdrawal

Measure	Sertraline Participants taking Sertraline according to Japanese Package Insert; This study is Special Investigation of JZOLOFT for panic disorder and one of conditions of this study is "patients who are diagnosed with panic disorder". So, all of participants in this study are panic disorder patients.
Overall Study Protocol Violation	79

Baseline Characteristics

Special Investigation Of J Zoloft For Panic Disorder Patients

Baseline characteristics by cohort

Measure	Sertraline n=908 Participants Participants taking Sertraline according to Japanese Package Insert
Age, Customized <65 years	863 participants n=5 Participants
Age, Customized >=65 years	45 participants n=5 Participants
Sex: Female, Male Female	592 Participants n=5 Participants
Sex: Female, Male Male	316 Participants n=5 Participants
Target Disease Severity Mild	325 participants n=5 Participants
Target Disease Severity Moderate	511 participants n=5 Participants
Target Disease Severity Severe	72 participants n=5 Participants
Complications Present	305 participants n=5 Participants
Complications Absent	603 participants n=5 Participants
Concomitant drug Present	671 participants n=5 Participants
Concomitant drug Absent	237 participants n=5 Participants
Starting dose 25 mg	699 participants n=5 Participants
Starting dose 50 mg	176 participants n=5 Participants
Starting dose 75 mg	18 participants n=5 Participants
Starting dose 100 mg	6 participants n=5 Participants
Starting dose other	9 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline up to 52 weeks

Population: 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=908 Participants Participants who took Sertraline according to Japanese Package Insert	50mg Participants whose starting dose were 50mg	75mg Participants whose starting dose were 75mg	100mg Participants whose starting dose were 100mg	Other Than Those Above Participants whose starting dose were other than 25mg, 50mg, 75mg and 100mg
Number of Participants of Treatment Related Adverse Events (TRAEs)	110 participants	—	—	—	—

PRIMARY outcome

Timeframe: Baseline up to 52 weeks

Population: The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.

Outcome measures

Measure	Sertraline n=908 Participants Participants who took Sertraline according to Japanese Package Insert	50mg Participants whose starting dose were 50mg	75mg Participants whose starting dose were 75mg	100mg Participants whose starting dose were 100mg	Other Than Those Above Participants whose starting dose were other than 25mg, 50mg, 75mg and 100mg
Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert Sedation	3 events	—	—	—	—
Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert Gastritis	2 events	—	—	—	—
Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert Hyperuricaemia	1 events	—	—	—	—
Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert Ventricular extrasystoles	1 events	—	—	—	—

SECONDARY outcome

Timeframe: Baseline up to 52 weeks

Population: The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.

Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether starting dose is significant risk factor

Outcome measures

Measure	Sertraline n=699 Participants Participants who took Sertraline according to Japanese Package Insert	50mg n=176 Participants Participants whose starting dose were 50mg	75mg n=18 Participants Participants whose starting dose were 75mg	100mg n=6 Participants Participants whose starting dose were 100mg	Other Than Those Above n=9 Participants Participants whose starting dose were other than 25mg, 50mg, 75mg and 100mg
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Starting Dose	101 participants	6 participants	0 participants	0 participants	3 participants

SECONDARY outcome

Timeframe: Baseline up to 52 weeks

Population: The safety analysis population consists of the cases that satisfy the participants 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=665 Participants Participants who took Sertraline according to Japanese Package Insert	50mg n=243 Participants Participants whose starting dose were 50mg	75mg Participants whose starting dose were 75mg	100mg Participants whose starting dose were 100mg	Other Than Those Above Participants whose starting dose were other than 25mg, 50mg, 75mg and 100mg
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Concomitant Drug	94 participants	16 participants	—	—	—

SECONDARY outcome

Timeframe: Baseline up to 52 weeks

Population: The safety analysis population consists of the cases that satisfy the participants 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 family history of psychiatric disorder is significant risk factor

Outcome measures

Measure	Sertraline n=52 Participants Participants who took Sertraline according to Japanese Package Insert	50mg n=697 Participants Participants whose starting dose were 50mg	75mg Participants whose starting dose were 75mg	100mg Participants whose starting dose were 100mg	Other Than Those Above Participants whose starting dose were other than 25mg, 50mg, 75mg and 100mg
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Family History of Psychiatric Disorder	11 participants	78 participants	—	—	—

SECONDARY outcome

Timeframe: Baseline up to 52 weeks

Population: The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.

Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether smoking status is significant risk factor

Outcome measures

Measure	Sertraline n=542 Participants Participants who took Sertraline according to Japanese Package Insert	50mg n=31 Participants Participants whose starting dose were 50mg	75mg n=142 Participants Participants whose starting dose were 75mg	100mg Participants whose starting dose were 100mg	Other Than Those Above Participants whose starting dose were other than 25mg, 50mg, 75mg and 100mg
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Smoking Status	57 participants	9 participants	30 participants	—	—

SECONDARY outcome

Timeframe: Baseline up to 52 weeks

Population: The safety analysis population consists of the cases that satisfy the participants 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=103 Participants Participants who took Sertraline according to Japanese Package Insert	50mg n=805 Participants Participants whose starting dose were 50mg	75mg Participants whose starting dose were 75mg	100mg Participants whose starting dose were 100mg	Other Than Those Above Participants whose starting dose were other than 25mg, 50mg, 75mg and 100mg
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Past Medical History of Other Illness	25 participants	85 participants	—	—	—

SECONDARY outcome

Timeframe: Baseline up to 52 weeks

Population: The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of was confirmed.

Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without non-pharmaceutical therapies is significant risk factor

Outcome measures

Measure	Sertraline n=405 Participants Participants who took Sertraline according to Japanese Package Insert	50mg n=503 Participants Participants whose starting dose were 50mg	75mg Participants whose starting dose were 75mg	100mg Participants whose starting dose were 100mg	Other Than Those Above Participants whose starting dose were other than 25mg, 50mg, 75mg and 100mg
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Non-Pharmaceutical Therapies	65 participants	45 participants	—	—	—

SECONDARY outcome

Timeframe: Baseline up to 52 weeks

Population: The safety analysis population consists of the cases that satisfy the participants 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 history of treatment prior to administration of Sertraline is significant risk factor

Outcome measures

Measure	Sertraline n=200 Participants Participants who took Sertraline according to Japanese Package Insert	50mg n=679 Participants Participants whose starting dose were 50mg	75mg Participants whose starting dose were 75mg	100mg Participants whose starting dose were 100mg	Other Than Those Above Participants whose starting dose were other than 25mg, 50mg, 75mg and 100mg
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: History of Treatment Prior to Administration of Sertraline	33 participants	73 participants	—	—	—

SECONDARY outcome

Timeframe: Baseline up to 52 weeks

Population: The safety analysis population consists of the cases that satisfy the participants 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 average daily dose is significant risk factor

Outcome measures

Measure	Sertraline n=13 Participants Participants who took Sertraline according to Japanese Package Insert	50mg n=529 Participants Participants whose starting dose were 50mg	75mg n=211 Participants Participants whose starting dose were 75mg	100mg n=151 Participants Participants whose starting dose were 100mg	Other Than Those Above n=4 Participants Participants whose starting dose were other than 25mg, 50mg, 75mg and 100mg
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Average Daily Dose	2 participants	92 participants	14 participants	2 participants	0 participants

SECONDARY outcome

Timeframe: Baseline up to 52 weeks

Population: The safety analysis population consists of the cases that satisfy the participants 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=305 Participants Participants who took Sertraline according to Japanese Package Insert	50mg n=603 Participants Participants whose starting dose were 50mg	75mg Participants whose starting dose were 75mg	100mg Participants whose starting dose were 100mg	Other Than Those Above Participants whose starting dose were other than 25mg, 50mg, 75mg and 100mg
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Complications	47 participants	63 participants	—	—	—

SECONDARY outcome

Timeframe: Baseline up to 52 weeks

Population: 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 concomitant drug is significant factor

Outcome measures

Measure	Sertraline n=649 Participants Participants who took Sertraline according to Japanese Package Insert	50mg n=232 Participants Participants whose starting dose were 50mg	75mg Participants whose starting dose were 75mg	100mg Participants whose starting dose were 100mg	Other Than Those Above Participants whose starting dose were other than 25mg, 50mg, 75mg and 100mg
Factors Considered to Affect the Efficacy of Sertraline: Concomitant Drug	565 participants	216 participants	—	—	—

SECONDARY outcome

Timeframe: Baseline up to 52 weeks

Population: 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, 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=292 Participants Participants who took Sertraline according to Japanese Package Insert	50mg n=589 Participants Participants whose starting dose were 50mg	75mg Participants whose starting dose were 75mg	100mg Participants whose starting dose were 100mg	Other Than Those Above Participants whose starting dose were other than 25mg, 50mg, 75mg and 100mg
Factors Considered to Affect the Efficacy of Sertraline: Complication	246 participants	535 participants	—	—	—

SECONDARY outcome

Timeframe: Baseline up to 52 weeks

Population: 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 drinking status is significant factor

Outcome measures

Measure	Sertraline n=200 Participants Participants who took Sertraline according to Japanese Package Insert	50mg n=335 Participants Participants whose starting dose were 50mg	75mg n=28 Participants Participants whose starting dose were 75mg	100mg n=128 Participants Participants whose starting dose were 100mg	Other Than Those Above n=65 Participants Participants whose starting dose were other than 25mg, 50mg, 75mg and 100mg
Factors Considered to Affect the Efficacy of Sertraline: Drinking Status	171 participants	312 participants	23 participants	118 participants	53 participants

Adverse Events

Sertraline

Serious events: 1 serious events

Other events: 110 other events

Deaths: 0 deaths

Serious adverse events

Measure

Sertraline n=908 participants at risk Participants taking Sertraline according to Japanese Package Insert.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. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product.

Psychiatric disorders Mania

0.11% 1/908 • 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=908 participants at risk Participants taking Sertraline according to Japanese Package Insert.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. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product.
Gastrointestinal disorders Nausea	3.4% 31/908 • Number of events 31 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	1.9% 17/908 • Number of events 17 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	1.4% 13/908 • Number of events 13 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	0.99% 9/908 • 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	0.66% 6/908 • 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.
General disorders Malaise	0.66% 6/908 • 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.
Nervous system disorders Dizziness	0.55% 5/908 • 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.
Metabolism and nutrition disorders Decreased appetite	0.33% 3/908 • 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	0.33% 3/908 • 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.
Nervous system disorders Sedation	0.33% 3/908 • 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 Dyspepsia	0.33% 3/908 • 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 Constipation	0.33% 3/908 • 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	0.22% 2/908 • 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	0.22% 2/908 • 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 Eczema	0.22% 2/908 • 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 Urticaria	0.22% 2/908 • 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.
Renal and urinary disorders Urinary retention	0.22% 2/908 • 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 Chills	0.22% 2/908 • 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 Asthenia	0.22% 2/908 • 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.
Metabolism and nutrition disorders Hyperuricaemia	0.11% 1/908 • 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 Sleep disorder	0.11% 1/908 • 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 Terminal insomnia	0.11% 1/908 • 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	0.11% 1/908 • 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 Mania	0.11% 1/908 • 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 Paraesthesia	0.11% 1/908 • 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 Tremor	0.11% 1/908 • 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.
Ear and labyrinth disorders Tinnitus	0.11% 1/908 • 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.
Cardiac disorders Ventricular extrasystoles	0.11% 1/908 • 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.
Cardiac disorders Palpitations	0.11% 1/908 • 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 Hot flush	0.11% 1/908 • 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 upper	0.11% 1/908 • 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 Hyperhidrosis	0.11% 1/908 • 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	0.11% 1/908 • 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.
Renal and urinary disorders Dysuria	0.11% 1/908 • 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.
Renal and urinary disorders Pollakiuria	0.11% 1/908 • 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 Ejaculation disorder	0.11% 1/908 • 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 Ejaculation failure	0.11% 1/908 • 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	0.11% 1/908 • 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	0.11% 1/908 • 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 Thirst	0.11% 1/908 • 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	0.11% 1/908 • 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.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

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