Trial Outcomes & Findings for Drug Use Investigation Of Varenicline (Regulatory Post Marketing Commitment Plan) (NCT NCT00772941)

NCT ID: NCT00772941

Last Updated: 2014-02-28

Results Overview

Number of participants with Treatment Related Adverse Events of Varenicline to determine whether gender is a significant risk factor.

• Recruitment status: COMPLETED
• Target enrollment: 3939 participants
• Primary outcome timeframe: 24 weeks
• Results posted on: 2014-02-28

Participant Flow

Participant milestones

Measure	Varenicline Participants taking Varenicline according to Japanese Package Insert.
Overall Study STARTED	3939
Overall Study COMPLETED	3257
Overall Study NOT COMPLETED	682

Reasons for withdrawal

Measure	Varenicline Participants taking Varenicline according to Japanese Package Insert.
Overall Study CRFs not available	195
Overall Study Study not completed	16
Overall Study Missed Visits	374
Overall Study Poor Compliance	7
Overall Study GPSP Violation	90

Baseline Characteristics

Drug Use Investigation Of Varenicline (Regulatory Post Marketing Commitment Plan)

Baseline characteristics by cohort

Measure	Varenicline n=3257 Participants Participants taking Varenicline according to Japanese Package Insert.
Age, Customized <65 years	2768 Participants n=5 Participants
Age, Customized >=65 years	489 Participants n=5 Participants
Sex: Female, Male Female	1078 Participants n=5 Participants
Sex: Female, Male Male	2179 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks

Population: The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.

Number of participants with Treatment Related Adverse Events of Varenicline to determine whether gender is a significant risk factor.

Outcome measures

Measure	Male n=2179 Participants Male participants taking Varenicline according to Japanese Package Insert.	Female n=1078 Participants Female participants taking Varenicline according to Japanese Package Insert.	>=50 kg and <60 kg at Baseline Participants whose weights at baseline were more than or equal to 50 kg and less than 60 kg.	>=60 kg and <70 kg at Baseline Participants whose weights at baseline were more than or equal to 60 kg and less than 70 kg.	>=70 kg and <80 kg at Baseline Participants whose weights at baseline were more than or equal to 70 kg and less than 80 kg.	>= 80 kg at Baseline Participants whose weights at baseline were more than or equal to 80 kg.
Risk Factors for the Frequency of Treatment Related Adverse Events - Gender.	377 participants	336 participants	—	—	—	—

PRIMARY outcome

Timeframe: 24 weeks

Population: The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.

Number of participants with Treatment Related Adverse Events of Varenicline to determine whether age is a significant risk factor.

Outcome measures

Measure	Male n=2768 Participants Male participants taking Varenicline according to Japanese Package Insert.	Female n=489 Participants Female participants taking Varenicline according to Japanese Package Insert.	>=50 kg and <60 kg at Baseline Participants whose weights at baseline were more than or equal to 50 kg and less than 60 kg.	>=60 kg and <70 kg at Baseline Participants whose weights at baseline were more than or equal to 60 kg and less than 70 kg.	>=70 kg and <80 kg at Baseline Participants whose weights at baseline were more than or equal to 70 kg and less than 80 kg.	>= 80 kg at Baseline Participants whose weights at baseline were more than or equal to 80 kg.
Risk Factors for the Frequency of Treatment Related Adverse Events - Age.	571 participants	142 participants	—	—	—	—

PRIMARY outcome

Timeframe: 24 weeks

Population: The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.

Number of participants with Treatment Related Adverse Events of Varenicline to determine whether Chronic obstructive pulmonary disease as a complication is a significant risk factor.

Outcome measures

Measure	Male n=46 Participants Male participants taking Varenicline according to Japanese Package Insert.	Female n=3211 Participants Female participants taking Varenicline according to Japanese Package Insert.	>=50 kg and <60 kg at Baseline Participants whose weights at baseline were more than or equal to 50 kg and less than 60 kg.	>=60 kg and <70 kg at Baseline Participants whose weights at baseline were more than or equal to 60 kg and less than 70 kg.	>=70 kg and <80 kg at Baseline Participants whose weights at baseline were more than or equal to 70 kg and less than 80 kg.	>= 80 kg at Baseline Participants whose weights at baseline were more than or equal to 80 kg.
Risk Factors for the Frequency of Treatment Related Adverse Events - Chronic Obstructive Pulmonary Disease as a Complication.	23 participants	690 participants	—	—	—	—

PRIMARY outcome

Timeframe: 24 weeks

Population: The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.

Number of participants with Treatment Related Adverse Events of Varenicline to determine whether taking concomitant drugs is a significant risk factor.

Outcome measures

Measure	Male n=738 Participants Male participants taking Varenicline according to Japanese Package Insert.	Female n=2519 Participants Female participants taking Varenicline according to Japanese Package Insert.	>=50 kg and <60 kg at Baseline Participants whose weights at baseline were more than or equal to 50 kg and less than 60 kg.	>=60 kg and <70 kg at Baseline Participants whose weights at baseline were more than or equal to 60 kg and less than 70 kg.	>=70 kg and <80 kg at Baseline Participants whose weights at baseline were more than or equal to 70 kg and less than 80 kg.	>= 80 kg at Baseline Participants whose weights at baseline were more than or equal to 80 kg.
Risk Factors for the Frequency of Treatment Related Adverse Events - Concomitant Drugs.	289 participants	424 participants	—	—	—	—

PRIMARY outcome

Timeframe: 24 weeks

Population: The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.

Number of participants with Treatment Related Adverse Events of Varenicline to determine whether receiving concomitant therapies is a significant risk factor.

Outcome measures

Measure	Male n=101 Participants Male participants taking Varenicline according to Japanese Package Insert.	Female n=3156 Participants Female participants taking Varenicline according to Japanese Package Insert.	>=50 kg and <60 kg at Baseline Participants whose weights at baseline were more than or equal to 50 kg and less than 60 kg.	>=60 kg and <70 kg at Baseline Participants whose weights at baseline were more than or equal to 60 kg and less than 70 kg.	>=70 kg and <80 kg at Baseline Participants whose weights at baseline were more than or equal to 70 kg and less than 80 kg.	>= 80 kg at Baseline Participants whose weights at baseline were more than or equal to 80 kg.
Risk Factors for the Frequency of Treatment Related Adverse Events - Concomitant Therapies.	45 participants	668 participants	—	—	—	—

PRIMARY outcome

Timeframe: 24 weeks

Population: The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed. The number of participants who provided weight data at baseline was 1700.

Number of participants with Treatment Related Adverse Events to determine whether weight at baseline is a significant risk factor.

Outcome measures

Measure	Male n=13 Participants Male participants taking Varenicline according to Japanese Package Insert.	Female n=215 Participants Female participants taking Varenicline according to Japanese Package Insert.	>=50 kg and <60 kg at Baseline n=453 Participants Participants whose weights at baseline were more than or equal to 50 kg and less than 60 kg.	>=60 kg and <70 kg at Baseline n=497 Participants Participants whose weights at baseline were more than or equal to 60 kg and less than 70 kg.	>=70 kg and <80 kg at Baseline n=342 Participants Participants whose weights at baseline were more than or equal to 70 kg and less than 80 kg.	>= 80 kg at Baseline n=180 Participants Participants whose weights at baseline were more than or equal to 80 kg.
Risk Factors for the Frequency of Treatment Related Adverse Events - Weight at Baseline.	6 participants	98 participants	135 participants	110 participants	61 participants	31 participants

PRIMARY outcome

Timeframe: 24 weeks

Population: The efficacy analysis population basically consists of the evaluable participants in accordance with the separately prepared analysis plan (participants judged to have been evaluated appropriately). The number of participants who provided data on daily tobacco consumption was 2827.

The primary analysis item was "the number of participants succeeding with continuous smoking cessation for the previous 4 weeks/the number of participants for efficacy evaluation excluding drop-out participants.

Outcome measures

Measure	Male n=1637 Participants Male participants taking Varenicline according to Japanese Package Insert.	Female n=1082 Participants Female participants taking Varenicline according to Japanese Package Insert.	>=50 kg and <60 kg at Baseline n=108 Participants Participants whose weights at baseline were more than or equal to 50 kg and less than 60 kg.	>=60 kg and <70 kg at Baseline Participants whose weights at baseline were more than or equal to 60 kg and less than 70 kg.	>=70 kg and <80 kg at Baseline Participants whose weights at baseline were more than or equal to 70 kg and less than 80 kg.	>= 80 kg at Baseline Participants whose weights at baseline were more than or equal to 80 kg.
Risk Factors for the Proportion of Responders - Tobacco Consumption Per Day.	1299 participants	817 participants	66 participants	—	—	—

PRIMARY outcome

Timeframe: 24 weeks

Population: The efficacy analysis population basically consists of the evaluable participants in accordance with the separately prepared analysis plan (participants judged to have been evaluated appropriately). The number of participants in whom the prolonged administration of Varenicline after 12 weeks was confirmed was 2598.

The primary analysis item was "the number of participants succeeding with continuous smoking cessation for the previous 4 weeks/the number of participants for efficacy evaluation excluding drop-out participants.

Outcome measures

Measure	Male n=64 Participants Male participants taking Varenicline according to Japanese Package Insert.	Female n=2534 Participants Female participants taking Varenicline according to Japanese Package Insert.	>=50 kg and <60 kg at Baseline Participants whose weights at baseline were more than or equal to 50 kg and less than 60 kg.	>=60 kg and <70 kg at Baseline Participants whose weights at baseline were more than or equal to 60 kg and less than 70 kg.	>=70 kg and <80 kg at Baseline Participants whose weights at baseline were more than or equal to 70 kg and less than 80 kg.	>= 80 kg at Baseline Participants whose weights at baseline were more than or equal to 80 kg.
Risk Factors for the Proportion of Responders - Prolonged Administration After 12 Weeks.	39 participants	1993 participants	—	—	—	—

PRIMARY outcome

Timeframe: 24 weeks

Population: The efficacy analysis population basically consists of the evaluable participants in accordance with the separately prepared analysis plan (participants judged to have been evaluated appropriately). The number of participants who provided data on concomitant administration of antipsychotics was 2842.

The primary analysis item was "the number of participants succeeding with continuous smoking cessation for the previous 4 weeks/the number of participants for efficacy evaluation excluding drop-out participants.

Outcome measures

Measure	Male n=140 Participants Male participants taking Varenicline according to Japanese Package Insert.	Female n=2702 Participants Female participants taking Varenicline according to Japanese Package Insert.	>=50 kg and <60 kg at Baseline Participants whose weights at baseline were more than or equal to 50 kg and less than 60 kg.	>=60 kg and <70 kg at Baseline Participants whose weights at baseline were more than or equal to 60 kg and less than 70 kg.	>=70 kg and <80 kg at Baseline Participants whose weights at baseline were more than or equal to 70 kg and less than 80 kg.	>= 80 kg at Baseline Participants whose weights at baseline were more than or equal to 80 kg.
Risk Factors for the Proportion of Responders - Antipsychotics as a Concomitant Drug.	85 participants	2111 participants	—	—	—	—

PRIMARY outcome

Timeframe: 24 weeks

Population: No statistical analysis provided for the frequency of treatment related adverse events.

Adverse events mean all unfavorable events that occur in participants after administration of Varenicline, irrespective of causal relationship to Varenicline (including clinically problematic abnormal changes in laboratory test values). Treatment related Adverse Events were evaluated in company with the causal relationship to Varenicline. The safety was evaluated on the first visit after 24 weeks; however, it was evaluated on the last visit for those who had stopped visiting before 24 weeks.

Outcome measures

Measure	Male n=3257 Participants Male participants taking Varenicline according to Japanese Package Insert.	Female Female participants taking Varenicline according to Japanese Package Insert.	>=50 kg and <60 kg at Baseline Participants whose weights at baseline were more than or equal to 50 kg and less than 60 kg.	>=60 kg and <70 kg at Baseline Participants whose weights at baseline were more than or equal to 60 kg and less than 70 kg.	>=70 kg and <80 kg at Baseline Participants whose weights at baseline were more than or equal to 70 kg and less than 80 kg.	>= 80 kg at Baseline Participants whose weights at baseline were more than or equal to 80 kg.
Number of Participants With Treatment Related Adverse Events.	713 participants	—	—	—	—	—

PRIMARY outcome

Timeframe: 24 weeks

Population: No statistical analysis provided for the frequency of unlisted treatment related adverse events.

Adverse events mean all unfavorable events that occur in participants after administration of Varenicline, irrespective of causal relationship to Varenicline (including clinically problematic abnormal changes in laboratory test values). Numbers of Treatment Related Adverse Events were evaluated in company with the causal relationship to Varenicline. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert. The safety was evaluated on the first visit after 24 weeks; however, it was evaluated on the last visit for those who had stopped visiting before 24 weeks.

Outcome measures

Measure	Male n=3257 Participants Male participants taking Varenicline according to Japanese Package Insert.	Female Female participants taking Varenicline according to Japanese Package Insert.	>=50 kg and <60 kg at Baseline Participants whose weights at baseline were more than or equal to 50 kg and less than 60 kg.	>=60 kg and <70 kg at Baseline Participants whose weights at baseline were more than or equal to 60 kg and less than 70 kg.	>=70 kg and <80 kg at Baseline Participants whose weights at baseline were more than or equal to 70 kg and less than 80 kg.	>= 80 kg at Baseline Participants whose weights at baseline were more than or equal to 80 kg.
Number of Unlisted Treatment Related Adverse Events According to Japanese Package Insert.	30 events	—	—	—	—	—

SECONDARY outcome

Timeframe: 52 weeks

Population: No statistical analysis provided for the frequency of Varenicline-dependent treatment related adverse events.

Number of participants with dependence on Varenicline by 52 weeks. Varenicline-dependent Treatment Related Adverse Events are Feeling abnormal, Feeling drunk, Feeling jittery, Disturbance in attention, Dizziness, Memory impairment, Mental impairment, Psychomotor hyperactivity, Sedation, Somnolence, Confusional state, Depersonalisation, Disorientation, Dissociation, Euphoric mood, Mood variable, Mood swings, and Hallucination.

Outcome measures

Measure	Male n=3257 Participants Male participants taking Varenicline according to Japanese Package Insert.	Female Female participants taking Varenicline according to Japanese Package Insert.	>=50 kg and <60 kg at Baseline Participants whose weights at baseline were more than or equal to 50 kg and less than 60 kg.	>=60 kg and <70 kg at Baseline Participants whose weights at baseline were more than or equal to 60 kg and less than 70 kg.	>=70 kg and <80 kg at Baseline Participants whose weights at baseline were more than or equal to 70 kg and less than 80 kg.	>= 80 kg at Baseline Participants whose weights at baseline were more than or equal to 80 kg.
Number of Participants With Continuous Abstinence Situation by 52 Weeks.	38 participants	—	—	—	—	—

Adverse Events

Varenicline

Serious events: 8 serious events

Other events: 708 other events

Deaths: 0 deaths

Serious adverse events

Measure	Varenicline n=3257 participants at risk Participants taking Varenicline according to Japanese Package Insert.
Psychiatric disorders Depression	0.03% 1/3257 • Number of events 1 The frequency of treatment related adverse events during the study.
Psychiatric disorders Suicidal ideation	0.03% 1/3257 • Number of events 1 The frequency of treatment related adverse events during the study.
Psychiatric disorders Insomnia	0.03% 1/3257 • Number of events 1 The frequency of treatment related adverse events during the study.
Nervous system disorders Lacunar infarction	0.03% 1/3257 • Number of events 1 The frequency of treatment related adverse events during the study.
Vascular disorders Hypertension	0.03% 1/3257 • Number of events 1 The frequency of treatment related adverse events during the study.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.03% 1/3257 • Number of events 1 The frequency of treatment related adverse events during the study.
Respiratory, thoracic and mediastinal disorders Asthma	0.03% 1/3257 • Number of events 1 The frequency of treatment related adverse events during the study.
Gastrointestinal disorders Ileus	0.03% 1/3257 • Number of events 1 The frequency of treatment related adverse events during the study.
Gastrointestinal disorders Mallory-Weiss syndrome	0.03% 1/3257 • Number of events 1 The frequency of treatment related adverse events during the study.
Gastrointestinal disorders Pancreatitis	0.03% 1/3257 • Number of events 1 The frequency of treatment related adverse events during the study.
General disorders Chest discomfort	0.03% 1/3257 • Number of events 1 The frequency of treatment related adverse events during the study.

Other adverse events

Measure	Varenicline n=3257 participants at risk Participants taking Varenicline according to Japanese Package Insert.
Psychiatric disorders Terminal insomnia	0.03% 1/3257 • Number of events 1 The frequency of treatment related adverse events during the study.
Psychiatric disorders Middle insomnia	0.03% 1/3257 • Number of events 1 The frequency of treatment related adverse events during the study.
Infections and infestations Herpes virus infection	0.03% 1/3257 • Number of events 1 The frequency of treatment related adverse events during the study.
Infections and infestations Gastroenteritis	0.06% 2/3257 • Number of events 2 The frequency of treatment related adverse events during the study.
Infections and infestations Oral herpes	0.06% 2/3257 • Number of events 2 The frequency of treatment related adverse events during the study.
Metabolism and nutrition disorders Decreased appetite	0.15% 5/3257 • Number of events 5 The frequency of treatment related adverse events during the study.
Psychiatric disorders Depression	0.18% 6/3257 • Number of events 6 The frequency of treatment related adverse events during the study.
Psychiatric disorders Nightmare	0.25% 8/3257 • Number of events 8 The frequency of treatment related adverse events during the study.
Psychiatric disorders Abnormal dreams	0.28% 9/3257 • Number of events 9 The frequency of treatment related adverse events during the study.
Psychiatric disorders Decreased activity	0.03% 1/3257 • Number of events 1 The frequency of treatment related adverse events during the study.
Psychiatric disorders Agitation	0.03% 1/3257 • Number of events 1 The frequency of treatment related adverse events during the study.
Psychiatric disorders Social avoidant behaviour	0.03% 1/3257 • Number of events 1 The frequency of treatment related adverse events during the study.
Psychiatric disorders Initial insomnia	0.03% 1/3257 • Number of events 1 The frequency of treatment related adverse events during the study.
Psychiatric disorders Bulimia nervosa	0.03% 1/3257 • Number of events 1 The frequency of treatment related adverse events during the study.
Psychiatric disorders Sleep disorder	0.09% 3/3257 • Number of events 3 The frequency of treatment related adverse events during the study.
Psychiatric disorders Anger	0.03% 1/3257 • Number of events 1 The frequency of treatment related adverse events during the study.
Psychiatric disorders Anxiety	0.03% 1/3257 • Number of events 1 The frequency of treatment related adverse events during the study.
Psychiatric disorders Anxiety disorder	0.06% 2/3257 • Number of events 2 The frequency of treatment related adverse events during the study.
Psychiatric disorders Dysphoria	0.03% 1/3257 • Number of events 1 The frequency of treatment related adverse events during the study.
Psychiatric disorders Insomnia	1.6% 51/3257 • Number of events 51 The frequency of treatment related adverse events during the study.
Psychiatric disorders Apathy	0.03% 1/3257 • Number of events 1 The frequency of treatment related adverse events during the study.
Psychiatric disorders Depressed mood	0.09% 3/3257 • Number of events 3 The frequency of treatment related adverse events during the study.
Psychiatric disorders Depressive symptom	0.18% 6/3257 • Number of events 6 The frequency of treatment related adverse events during the study.
Psychiatric disorders Restlessness	0.03% 1/3257 • Number of events 1 The frequency of treatment related adverse events during the study.
Nervous system disorders Somnolence	0.71% 23/3257 • Number of events 23 The frequency of treatment related adverse events during the study.
Nervous system disorders Headache	1.1% 35/3257 • Number of events 35 The frequency of treatment related adverse events during the study.
Nervous system disorders Dementia	0.03% 1/3257 • Number of events 1 The frequency of treatment related adverse events during the study.
Nervous system disorders Dizziness	0.40% 13/3257 • Number of events 13 The frequency of treatment related adverse events during the study.
Nervous system disorders Migraine	0.03% 1/3257 • Number of events 1 The frequency of treatment related adverse events during the study.
Nervous system disorders Dysgeusia	0.09% 3/3257 • Number of events 3 The frequency of treatment related adverse events during the study.
Ear and labyrinth disorders Tinnitus	0.06% 2/3257 • Number of events 2 The frequency of treatment related adverse events during the study.
Cardiac disorders Palpitations	0.06% 2/3257 • Number of events 2 The frequency of treatment related adverse events during the study.
Vascular disorders Peripheral coldness	0.03% 1/3257 • Number of events 1 The frequency of treatment related adverse events during the study.
Respiratory, thoracic and mediastinal disorders Cough	0.03% 1/3257 • Number of events 1 The frequency of treatment related adverse events during the study.
Gastrointestinal disorders Eructation	0.03% 1/3257 • Number of events 1 The frequency of treatment related adverse events during the study.
Gastrointestinal disorders Nausea	12.2% 397/3257 • Number of events 397 The frequency of treatment related adverse events during the study.
Gastrointestinal disorders Gastritis	1.5% 49/3257 • Number of events 49 The frequency of treatment related adverse events during the study.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.15% 5/3257 • Number of events 5 The frequency of treatment related adverse events during the study.
Gastrointestinal disorders Diarrhoea	0.31% 10/3257 • Number of events 10 The frequency of treatment related adverse events during the study.
Gastrointestinal disorders Flatulence	0.03% 1/3257 • Number of events 1 The frequency of treatment related adverse events during the study.
Gastrointestinal disorders Stomatitis	0.18% 6/3257 • Number of events 6 The frequency of treatment related adverse events during the study.
Gastrointestinal disorders Dyspepsia	0.21% 7/3257 • Number of events 7 The frequency of treatment related adverse events during the study.
Gastrointestinal disorders Abdominal pain upper	0.68% 22/3257 • Number of events 22 The frequency of treatment related adverse events during the study.
Gastrointestinal disorders Glossitis	0.06% 2/3257 • Number of events 2 The frequency of treatment related adverse events during the study.
Gastrointestinal disorders Abdominal pain	0.09% 3/3257 • Number of events 3 The frequency of treatment related adverse events during the study.
Gastrointestinal disorders Abdominal discomfort	0.55% 18/3257 • Number of events 18 The frequency of treatment related adverse events during the study.
Gastrointestinal disorders Abdominal distension	0.37% 12/3257 • Number of events 12 The frequency of treatment related adverse events during the study.
Gastrointestinal disorders Constipation	2.8% 91/3257 • Number of events 91 The frequency of treatment related adverse events during the study.
Gastrointestinal disorders Vomiting	1.2% 39/3257 • Number of events 39 The frequency of treatment related adverse events during the study.
Hepatobiliary disorders Liver disorder	0.03% 1/3257 • Number of events 1 The frequency of treatment related adverse events during the study.
Hepatobiliary disorders Hepatitis acute	0.03% 1/3257 • Number of events 1 The frequency of treatment related adverse events during the study.
Hepatobiliary disorders Cholestasis	0.03% 1/3257 • Number of events 1 The frequency of treatment related adverse events during the study.
Skin and subcutaneous tissue disorders Pruritus	0.09% 3/3257 • Number of events 3 The frequency of treatment related adverse events during the study.
Skin and subcutaneous tissue disorders Eczema	0.09% 3/3257 • Number of events 3 The frequency of treatment related adverse events during the study.
Skin and subcutaneous tissue disorders Rash generalised	0.03% 1/3257 • Number of events 1 The frequency of treatment related adverse events during the study.
Skin and subcutaneous tissue disorders Rash	0.03% 1/3257 • Number of events 1 The frequency of treatment related adverse events during the study.
Skin and subcutaneous tissue disorders Drug eruption	0.06% 2/3257 • Number of events 2 The frequency of treatment related adverse events during the study.
Skin and subcutaneous tissue disorders Urticaria	0.06% 2/3257 • Number of events 2 The frequency of treatment related adverse events during the study.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.03% 1/3257 • Number of events 1 The frequency of treatment related adverse events during the study.
Renal and urinary disorders Pollakiuria	0.03% 1/3257 • Number of events 1 The frequency of treatment related adverse events during the study.
Renal and urinary disorders Renal failure chronic	0.03% 1/3257 • Number of events 1 The frequency of treatment related adverse events during the study.
Renal and urinary disorders Nocturia	0.06% 2/3257 • Number of events 2 The frequency of treatment related adverse events during the study.
Reproductive system and breast disorders Lactation disorder	0.03% 1/3257 • Number of events 1 The frequency of treatment related adverse events during the study.
General disorders Irritability	0.18% 6/3257 • Number of events 6 The frequency of treatment related adverse events during the study.
General disorders Feeling abnormal	0.09% 3/3257 • Number of events 3 The frequency of treatment related adverse events during the study.
General disorders Chest discomfort	0.03% 1/3257 • Number of events 1 The frequency of treatment related adverse events during the study.
General disorders Malaise	0.31% 10/3257 • Number of events 10 The frequency of treatment related adverse events during the study.
General disorders Thirst	0.12% 4/3257 • Number of events 4 The frequency of treatment related adverse events during the study.
General disorders Pyrexia	0.03% 1/3257 • Number of events 1 The frequency of treatment related adverse events during the study.
General disorders Fatigue	0.03% 1/3257 • Number of events 1 The frequency of treatment related adverse events during the study.
General disorders Asthenia	0.03% 1/3257 • Number of events 1 The frequency of treatment related adverse events during the study.
General disorders Pain	0.03% 1/3257 • Number of events 1 The frequency of treatment related adverse events during the study.
Investigations Blood pressure increased	0.06% 2/3257 • Number of events 2 The frequency of treatment related adverse events during the study.
Investigations Blood creatinine increased	0.03% 1/3257 • Number of events 1 The frequency of treatment related adverse events during the study.
Investigations Weight increased	0.06% 2/3257 • Number of events 2 The frequency of treatment related adverse events during the study.

Additional Information

Pfizer ClinicalTrials.gov Call Center

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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