Trial Outcomes & Findings for Safety And Efficacy In Long Term Use Of Lyrica (Regulatory Post Marketing Commitment Plan) (NCT NCT01279850)

NCT ID: NCT01279850

Last Updated: 2023-10-10

Results Overview

An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Relatedness to LYRICA Capsules was assessed by the physician.

• Recruitment status: COMPLETED
• Target enrollment: 891 participants
• Primary outcome timeframe: From Week 1 to Week 104 at maximum
• Results posted on: 2023-10-10

Participant Flow

Participant milestones

Measure	LYRICA Capsules (Pregabalin) Participants who received LYRICA Capsules as indicated in the approved local product document were observed from the start of the treatment to Week 104 at maximum. The dosage can be adjusted as per physician's discretion.
Overall Study STARTED	891
Overall Study COMPLETED	800
Overall Study NOT COMPLETED	91

Reasons for withdrawal

Measure	LYRICA Capsules (Pregabalin) Participants who received LYRICA Capsules as indicated in the approved local product document were observed from the start of the treatment to Week 104 at maximum. The dosage can be adjusted as per physician's discretion.
Overall Study Protocol Violation	50
Overall Study No Drug Administration Information	7
Overall Study No Visit After Treatment	34

Baseline Characteristics

Safety And Efficacy In Long Term Use Of Lyrica (Regulatory Post Marketing Commitment Plan)

Baseline characteristics by cohort

Measure	LYRICA Capsules (Pregabalin) n=800 Participants Participants who received LYRICA Capsules as indicated in the approved local product document were observed from the start of the treatment to Week 104 at maximum. The dosage can be adjusted as per physician's discretion.
Age, Customized <15 years	0 Participants n=93 Participants
Age, Customized ≥15 and <65 years	267 Participants n=93 Participants
Age, Customized ≥65 years	533 Participants n=93 Participants
Sex/Gender, Customized Male	358 Participants n=93 Participants
Sex/Gender, Customized Female	442 Participants n=93 Participants
Race/Ethnicity, Customized Race and Ethnicity Not Collected	800 Participants n=93 Participants

PRIMARY outcome

Timeframe: From Week 1 to Week 104 at maximum

Population: The analysis population for this outcome measure was the baseline analysis population, which comprised of participants who satisfied the criteria of safety analysis population and had received LYRICA Capsules at least once.

An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Relatedness to LYRICA Capsules was assessed by the physician.

Outcome measures

Measure	LYRICA Capsules (Pregabalin) n=800 Participants Participants who received LYRICA Capsules as indicated in the approved local product document were observed from the start of the treatment to Week 104 at maximum. The dosage can be adjusted as per physician's discretion.
Percentage of Participants With Adverse Drug Reaction	12.75 Percentage of Participants

SECONDARY outcome

Timeframe: From Week 1 to Week 104 at maximum

Population: The analysis population for this outcome measure was the baseline analysis population, which comprised of participants who satisfied the criteria of safety analysis population and had received LYRICA Capsules at least once.

An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to LYRICA Capsules was assessed by the physician.

Outcome measures

Measure	LYRICA Capsules (Pregabalin) n=800 Participants Participants who received LYRICA Capsules as indicated in the approved local product document were observed from the start of the treatment to Week 104 at maximum. The dosage can be adjusted as per physician's discretion.
Percentage of Participants With Serious Adverse Drug Reaction	0.25 Percentage of Participants

SECONDARY outcome

Timeframe: From Week 1 to Week 104 at maximum

Population: The analysis population for this outcome measure was the baseline analysis population, which comprised of participants who satisfied the criteria of safety analysis population and had received LYRICA Capsules at least once.

An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to LYRICA Capsules was assessed by the physician.

Outcome measures

Measure	LYRICA Capsules (Pregabalin) n=800 Participants Participants who received LYRICA Capsules as indicated in the approved local product document were observed from the start of the treatment to Week 104 at maximum. The dosage can be adjusted as per physician's discretion.
Percentage of Participants With Adverse Drug Reaction Unexpected From Japanese Package Insert	0.50 Percentage of Participants

SECONDARY outcome

Timeframe: From Week 1 to Week 104 at maximum

Population: The analysis population for this outcome measure was the baseline analysis population, which comprised of participants who satisfied the criteria of safety analysis population and had received LYRICA Capsules at least once.

An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Relatedness to LYRICA Capsules was assessed by the physician. Occurrence of ADRs related to peripheral edema or other edema-related events was evaluated.

Outcome measures

Measure	LYRICA Capsules (Pregabalin) n=800 Participants Participants who received LYRICA Capsules as indicated in the approved local product document were observed from the start of the treatment to Week 104 at maximum. The dosage can be adjusted as per physician's discretion.
Number of Participants With Adverse Drug Reactions Related to Peripheral Edema or Other Edema-related Events	14 Participants

SECONDARY outcome

Timeframe: From Week 1 to Week 104 at maximum

Population: The analysis population for this outcome measure was the baseline analysis population, which comprised of participants who satisfied the criteria of safety analysis population and had received LYRICA Capsules at least once.

An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Relatedness to LYRICA Capsules was assessed by the physician. Occurrence of ADRs related to dizziness, somnolence, loss of consciousness, syncope, and potential for accidental injury was evaluated.

Outcome measures

Measure	LYRICA Capsules (Pregabalin) n=800 Participants Participants who received LYRICA Capsules as indicated in the approved local product document were observed from the start of the treatment to Week 104 at maximum. The dosage can be adjusted as per physician's discretion.
Number of Participants With Adverse Drug Reactions Related to Dizziness, Somnolence, Loss of Consciousness, Syncope, and Potential for Accidental Injury	65 Participants

SECONDARY outcome

Timeframe: From Week 1 to Week 104 at maximum

Population: The analysis population for this outcome measure was the baseline analysis population, which comprised of participants who satisfied the criteria of safety analysis population and had received LYRICA Capsules at least once.

An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Relatedness to LYRICA Capsules was assessed by the physician. Occurrence of ADRs related to vision-related events was evaluated.

Outcome measures

Measure	LYRICA Capsules (Pregabalin) n=800 Participants Participants who received LYRICA Capsules as indicated in the approved local product document were observed from the start of the treatment to Week 104 at maximum. The dosage can be adjusted as per physician's discretion.
Number of Participants With Adverse Drug Reactions Related to Vision-related Events	4 Participants

SECONDARY outcome

Timeframe: At Week 104

Population: The analysis population for this outcome measure comprised of participants for whom the evaluation outcome of clinical effectiveness was available and who satisfied the inclusion criteria among the baseline analysis population. Of these, participants evaluated as "impossible to judge" were excluded from the analysis population.

Clinical effectiveness of LYRICA Capsules was determined by the physician based on the following categories: (1) effective, (2) ineffective, or (3) impossible to judge at Week 104 of the treatment. Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of the analysis population, was presented along with the corresponding 2-sided 95% CI.

Outcome measures

Measure	LYRICA Capsules (Pregabalin) n=777 Participants Participants who received LYRICA Capsules as indicated in the approved local product document were observed from the start of the treatment to Week 104 at maximum. The dosage can be adjusted as per physician's discretion.
Clinical Effectiveness Rate	91.0 Percentage of Participants Interval 88.8 to 93.0

SECONDARY outcome

Timeframe: Baseline and at Week 104

Population: The analysis population for this outcome measure comprised of participants for whom the evaluation outcome of participant-rated pain score was available and who satisfied the inclusion criteria among the baseline analysis population.

The pain experienced at Week 104 during the past 24 hours was rated by participants at the time of getting up in the morning on an 11-grade scale, ranging from 0 (no pain) to 10 (the most severe pain possible). Mean change from baseline in participant-rated pain score at Week 104 was presented along with standard deviation.

Outcome measures

Measure	LYRICA Capsules (Pregabalin) n=113 Participants Participants who received LYRICA Capsules as indicated in the approved local product document were observed from the start of the treatment to Week 104 at maximum. The dosage can be adjusted as per physician's discretion.
Change From Baseline in Participant-rated Pain Score at Week 104	-4.4 Units on a scale Standard Deviation 2.14

SECONDARY outcome

Timeframe: Baseline and at Week 104

Population: The analysis population for this outcome measure comprised of participants for whom the evaluation outcome of participant-rated sleep interference score was available and who satisfied the inclusion criteria among the baseline analysis population.

The sleep interference (inability to sleep because of pain) experienced at Week 104 during the past 24 hours was rated by participants at the time of getting up in the morning on an 11-grade scale, ranging from 0 (no disturbance) to 10 (totally unable to sleep because of pain). Mean change from baseline in participant-rated sleep interference score at Week 104 was presented along with standard deviation.

Outcome measures

Measure	LYRICA Capsules (Pregabalin) n=104 Participants Participants who received LYRICA Capsules as indicated in the approved local product document were observed from the start of the treatment to Week 104 at maximum. The dosage can be adjusted as per physician's discretion.
Change From Baseline in Participant-rated Sleep Interference Score at Week 104	-3.9 Units on a scale Standard Deviation 2.54

SECONDARY outcome

Timeframe: At Week 104

Population: The analysis population for this outcome measure comprised of participants for whom the evaluation outcome of PGIC was available and who satisfied the inclusion criteria among the baseline analysis population.

The patient's impression (patient global impression of change [PGIC]) at Week 104, as compared to the baseline condition (including the first day of treatment), was rated by participants on a 7-grade scale.

Outcome measures

Measure	LYRICA Capsules (Pregabalin) n=791 Participants Participants who received LYRICA Capsules as indicated in the approved local product document were observed from the start of the treatment to Week 104 at maximum. The dosage can be adjusted as per physician's discretion.
Patient's Impression (PGIC) at Week 104 Markedly improved	95 Participants
Patient's Impression (PGIC) at Week 104 Improved	223 Participants
Patient's Impression (PGIC) at Week 104 Slightly improved	183 Participants
Patient's Impression (PGIC) at Week 104 Unchanged	71 Participants
Patient's Impression (PGIC) at Week 104 Slightly worsened	3 Participants
Patient's Impression (PGIC) at Week 104 Worsened	2 Participants
Patient's Impression (PGIC) at Week 104 Markedly worsened	0 Participants
Patient's Impression (PGIC) at Week 104 Not assessed	214 Participants

SECONDARY outcome

Timeframe: At Week 104

Population: The analysis population for this outcome measure comprised of participants for whom the evaluation outcome of CGIC was available and who satisfied the inclusion criteria among the baseline analysis population.

The physician's impression (clinical global impression of change [CGIC]) at Week 104, as compared to the baseline condition (including the first day of treatment), was rated by the physician on a 7-grade scale.

Outcome measures

Measure	LYRICA Capsules (Pregabalin) n=791 Participants Participants who received LYRICA Capsules as indicated in the approved local product document were observed from the start of the treatment to Week 104 at maximum. The dosage can be adjusted as per physician's discretion.
Physician's Impression (CGIC) at Week 104 Markedly improved	108 Participants
Physician's Impression (CGIC) at Week 104 Improved	275 Participants
Physician's Impression (CGIC) at Week 104 Slightly improved	179 Participants
Physician's Impression (CGIC) at Week 104 Unchanged	93 Participants
Physician's Impression (CGIC) at Week 104 Slightly worsened	7 Participants
Physician's Impression (CGIC) at Week 104 Worsened	0 Participants
Physician's Impression (CGIC) at Week 104 Markedly worsened	0 Participants
Physician's Impression (CGIC) at Week 104 Not assessed	129 Participants

Adverse Events

LYRICA Capsules (Pregabalin)

Serious events: 22 serious events

Other events: 153 other events

Deaths: 7 deaths

Serious adverse events

Measure	LYRICA Capsules (Pregabalin) n=800 participants at risk Participants who received LYRICA Capsules as indicated in the approved local product document were observed from the start of the treatment to Week 104 at maximum. The dosage can be adjusted as per physician's discretion.
Infections and infestations Pneumonia	0.25% 2/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer female	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to meninges	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma recurrent	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal neoplasm	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer metastatic	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine cancer	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Metabolism and nutrition disorders Diabetes mellitus	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Nervous system disorders Brain oedema	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Nervous system disorders Cerebral haemorrhage	0.25% 2/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Nervous system disorders Cerebral infarction	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Nervous system disorders Dizziness	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Nervous system disorders Vocal cord paralysis	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Eye disorders Cataract	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Eye disorders Glaucoma	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Cardiac disorders Angina pectoris	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Cardiac disorders Cardiac failure	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Gastrointestinal disorders Ileus	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Gastrointestinal disorders Intestinal perforation	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Renal and urinary disorders Azotaemia	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
General disorders Asthenia	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
General disorders Condition aggravated	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
General disorders Disease progression	0.25% 2/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
General disorders Multiple organ dysfunction syndrome	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
General disorders Sudden death	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Injury, poisoning and procedural complications Rib fracture	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Injury, poisoning and procedural complications Spinal compression fracture	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.

Other adverse events

Measure	LYRICA Capsules (Pregabalin) n=800 participants at risk Participants who received LYRICA Capsules as indicated in the approved local product document were observed from the start of the treatment to Week 104 at maximum. The dosage can be adjusted as per physician's discretion.
Blood and lymphatic system disorders Febrile neutropenia	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Blood and lymphatic system disorders Iron deficiency anaemia	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Cardiac disorders Angina pectoris	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Cardiac disorders Atrial fibrillation	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Cardiac disorders Cardiac failure	0.25% 2/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Cardiac disorders Cardiac failure chronic	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Cardiac disorders Cardiac failure congestive	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Cardiac disorders Palpitations	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Ear and labyrinth disorders Vertigo	0.50% 4/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Eye disorders Abnormal sensation in eye	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Eye disorders Cataract	0.25% 2/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Eye disorders Conjunctivitis allergic	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Eye disorders Diabetic retinopathy	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Eye disorders Vision blurred	0.38% 3/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Gastrointestinal disorders Abdominal discomfort	0.25% 2/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Gastrointestinal disorders Abdominal pain	0.25% 2/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Gastrointestinal disorders Chronic gastritis	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Gastrointestinal disorders Constipation	1.6% 13/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Gastrointestinal disorders Diarrhoea	0.38% 3/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Gastrointestinal disorders Dyspepsia	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Gastrointestinal disorders Dysphagia	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Gastrointestinal disorders Gastric ulcer	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Gastrointestinal disorders Gastritis erosive	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Gastrointestinal disorders Nausea	0.50% 4/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Gastrointestinal disorders Stomatitis	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Gastrointestinal disorders Vomiting	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
General disorders Chest pain	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
General disorders Face oedema	0.50% 4/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
General disorders Oedema	0.62% 5/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
General disorders Oedema peripheral	2.1% 17/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
General disorders Peripheral swelling	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
General disorders Thirst	0.38% 3/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Hepatobiliary disorders Alcoholic liver disease	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Immune system disorders Seasonal allergy	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Infections and infestations Bronchitis	0.25% 2/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Infections and infestations Candida infection	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Infections and infestations Cellulitis	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Infections and infestations Cystitis	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Infections and infestations Folliculitis	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Infections and infestations Infected dermal cyst	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Infections and infestations Influenza	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Infections and infestations Pharyngitis	0.38% 3/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Infections and infestations Pneumonia	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Infections and infestations Pyoderma	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Infections and infestations Tinea pedis	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Infections and infestations Viral upper respiratory tract infection	0.62% 5/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Injury, poisoning and procedural complications Avulsion fracture	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Injury, poisoning and procedural complications Contusion	0.25% 2/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Injury, poisoning and procedural complications Fall	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Injury, poisoning and procedural complications Hand fracture	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Injury, poisoning and procedural complications Laceration	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Injury, poisoning and procedural complications Ligament sprain	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Injury, poisoning and procedural complications Road traffic accident	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Investigations Alanine aminotransferase increased	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Investigations Aspartate aminotransferase increased	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Investigations Blood creatine phosphokinase increased	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Investigations Blood glucose fluctuation	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Investigations Blood lactate dehydrogenase increased	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Investigations Weight decreased	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Investigations Weight increased	1.0% 8/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Investigations White blood cell count decreased	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Metabolism and nutrition disorders Decreased appetite	0.25% 2/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Metabolism and nutrition disorders Diabetes mellitus	0.75% 6/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Metabolism and nutrition disorders Fluid retention	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Metabolism and nutrition disorders Hyperglycaemia	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Metabolism and nutrition disorders Hyperlipidaemia	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Metabolism and nutrition disorders Hyperuricaemia	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Musculoskeletal and connective tissue disorders Arthralgia	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Musculoskeletal and connective tissue disorders Arthritis	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Musculoskeletal and connective tissue disorders Joint swelling	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Musculoskeletal and connective tissue disorders Neck pain	0.25% 2/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Musculoskeletal and connective tissue disorders Osteoporosis	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Musculoskeletal and connective tissue disorders Pain in extremity	0.25% 2/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Musculoskeletal and connective tissue disorders Periarthritis	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Nervous system disorders Carpal tunnel syndrome	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Nervous system disorders Diabetic neuropathy	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Nervous system disorders Dizziness	4.8% 38/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Nervous system disorders Dysgeusia	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Nervous system disorders Hypoaesthesia	0.25% 2/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Nervous system disorders Loss of consciousness	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Nervous system disorders Migraine	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Nervous system disorders Post herpetic neuralgia	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Nervous system disorders Somnolence	4.5% 36/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Nervous system disorders Syncope	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Psychiatric disorders Insomnia	0.75% 6/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Psychiatric disorders Panic disorder	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Psychiatric disorders Sleep disorder	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Renal and urinary disorders Hypertonic bladder	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Renal and urinary disorders Renal failure	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Renal and urinary disorders Renal impairment	0.25% 2/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Reproductive system and breast disorders Dysmenorrhoea	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Respiratory, thoracic and mediastinal disorders Cough	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.38% 3/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract inflammation	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Skin and subcutaneous tissue disorders Asteatosis	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Skin and subcutaneous tissue disorders Dermatitis contact	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Skin and subcutaneous tissue disorders Eczema	0.25% 2/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Skin and subcutaneous tissue disorders Fixed eruption	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Skin and subcutaneous tissue disorders Pruritus	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Skin and subcutaneous tissue disorders Skin erosion	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Skin and subcutaneous tissue disorders Toxic skin eruption	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Skin and subcutaneous tissue disorders Vitiligo	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Vascular disorders Essential hypertension	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Vascular disorders Hot flush	0.25% 2/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Vascular disorders Hypertension	0.62% 5/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Vascular disorders Intermittent claudication	0.12% 1/800 • From Week 1 to Week 104 at maximum The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.

Additional Information

Pfizer ClinicalTrials.gov Call Center

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Phone: 1-800-718-1021

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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