Trial Outcomes & Findings for Safety And Efficacy Of Lyrica (Regulatory Post Marketing Commitment Plan) (NCT NCT01256593)

NCT ID: NCT01256593

Last Updated: 2023-09-15

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: 3827 participants
• Primary outcome timeframe: 13 weeks at maximum
• Results posted on: 2023-09-15

Participant Flow

Participant milestones

Measure	LYRICA Capsules (Pregabalin) Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 13 weeks at maximum. The dosage can be adjusted as per physician's discretion.
Overall Study STARTED	3827
Overall Study COMPLETED	3613
Overall Study NOT COMPLETED	214

Reasons for withdrawal

Measure	LYRICA Capsules (Pregabalin) Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 13 weeks at maximum. The dosage can be adjusted as per physician's discretion.
Overall Study Protocol Violation	26
Overall Study No Drug Administration Information	2
Overall Study No Visit After Treatment	186

Baseline Characteristics

Safety And Efficacy Of Lyrica (Regulatory Post Marketing Commitment Plan)

Baseline characteristics by cohort

Measure	LYRICA Capsules (Pregabalin) n=3613 Participants Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 13 weeks at maximum. The dosage can be adjusted as per physician's discretion.
Age, Customized <15 years	3 Participants n=5 Participants
Age, Customized ≥15 and <65 years	1330 Participants n=5 Participants
Age, Customized ≥65 years	2280 Participants n=5 Participants
Sex/Gender, Customized Male	1684 Participants n=5 Participants
Sex/Gender, Customized Female	1929 Participants n=5 Participants
Race/Ethnicity, Customized Race and Ethnicity Not Collected	3613 Participants n=5 Participants

PRIMARY outcome

Timeframe: 13 weeks 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=3613 Participants Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 13 weeks at maximum. The dosage can be adjusted as per physician's discretion.
Percentage of Participants With Adverse Drug Reaction	15.03 Percentage of Participants

SECONDARY outcome

Timeframe: 13 weeks 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=3613 Participants Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 13 weeks at maximum. The dosage can be adjusted as per physician's discretion.
Percentage of Participants With Serious Adverse Drug Reaction	0.61 Percentage of Participants

SECONDARY outcome

Timeframe: 13 weeks 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=3613 Participants Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 13 weeks at maximum. The dosage can be adjusted as per physician's discretion.
The Percentage of Participants With Adverse Drug Reaction Unexpected From Japanese Package Insert	0.42 Percentage of Participants

SECONDARY outcome

Timeframe: 13 weeks 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=3613 Participants Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 13 weeks 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	53 Participants

SECONDARY outcome

Timeframe: 13 weeks 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=3613 Participants Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 13 weeks 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	351 Participants

SECONDARY outcome

Timeframe: 13 weeks 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=3613 Participants Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 13 weeks at maximum. The dosage can be adjusted as per physician's discretion.
Number of Participants With Adverse Drug Reactions Related to Vision-related Events	16 Participants

SECONDARY outcome

Timeframe: At Week 13

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 13 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. For the participants who completed or discontinued the treatment before Week 13, the data at the time of the completion or discontinuation was used for the analysis.

Outcome measures

Measure	LYRICA Capsules (Pregabalin) n=3567 Participants Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 13 weeks at maximum. The dosage can be adjusted as per physician's discretion.
Clinical Effectiveness Rate	84.1 Percentage of Participants Interval 82.8 to 85.3

SECONDARY outcome

Timeframe: Baseline and at Week 13

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 13 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 13 was presented along with standard deviation. For the participants who completed or discontinued the treatment before Week 13, the data at the time of the completion or discontinuation was used for the analysis.

Outcome measures

Measure	LYRICA Capsules (Pregabalin) n=1843 Participants Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 13 weeks at maximum. The dosage can be adjusted as per physician's discretion.
Change From Baseline in Participant-rated Pain Score at Week 13	-3.4 Units on a scale Standard Deviation 2.61

SECONDARY outcome

Timeframe: Baseline and at Week 13

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 13 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 13 was presented along with standard deviation. For the participants who completed or discontinued the treatment before Week 13, the data at the time of the completion or discontinuation was used for the analysis.

Outcome measures

Measure	LYRICA Capsules (Pregabalin) n=1550 Participants Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 13 weeks at maximum. The dosage can be adjusted as per physician's discretion.
Change From Baseline in Participant-rated Sleep Interference Score at Week 13	-2.4 Units on a scale Standard Deviation 2.90

SECONDARY outcome

Timeframe: At Week 13

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 13, as compared to the baseline condition (including the first day of treatment), was rated by participants on a 7-grade scale. For the participants who completed or discontinued the treatment before Week 13, the data at the time of the completion or discontinuation was used for the analysis.

Outcome measures

Measure	LYRICA Capsules (Pregabalin) n=3567 Participants Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 13 weeks at maximum. The dosage can be adjusted as per physician's discretion.
Patient's Impression (PGIC) at Week 13 Markedly improved	583 Participants
Patient's Impression (PGIC) at Week 13 Improved	1039 Participants
Patient's Impression (PGIC) at Week 13 Slightly improved	708 Participants
Patient's Impression (PGIC) at Week 13 Unchanged	454 Participants
Patient's Impression (PGIC) at Week 13 Slightly worsened	12 Participants
Patient's Impression (PGIC) at Week 13 Worsened	11 Participants
Patient's Impression (PGIC) at Week 13 Markedly worsened	1 Participants
Patient's Impression (PGIC) at Week 13 Not assessed	759 Participants

SECONDARY outcome

Timeframe: At Week 13

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 13, as compared to the baseline condition (including the first day of treatment), was rated by the physician on a 7-grade scale. For the participants who completed or discontinued the treatment before Week 13, the data at the time of the completion or discontinuation was used for the analysis.

Outcome measures

Measure	LYRICA Capsules (Pregabalin) n=3567 Participants Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 13 weeks at maximum. The dosage can be adjusted as per physician's discretion.
Physician's Impression (CGIC) at Week 13 Slightly improved	773 Participants
Physician's Impression (CGIC) at Week 13 Unchanged	471 Participants
Physician's Impression (CGIC) at Week 13 Slightly worsened	9 Participants
Physician's Impression (CGIC) at Week 13 Worsened	6 Participants
Physician's Impression (CGIC) at Week 13 Markedly worsened	1 Participants
Physician's Impression (CGIC) at Week 13 Not assessed	532 Participants
Physician's Impression (CGIC) at Week 13 Markedly improved	626 Participants
Physician's Impression (CGIC) at Week 13 Improved	1149 Participants

Adverse Events

LYRICA Capsules (Pregabalin)

Serious events: 77 serious events

Other events: 636 other events

Deaths: 17 deaths

Serious adverse events

Measure	LYRICA Capsules (Pregabalin) n=3613 participants at risk Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 13 weeks at maximum. The dosage can be adjusted as per physician's discretion.
Infections and infestations Gangrene	0.03% 1/3613 • 13 weeks 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 Herpes virus infection	0.03% 1/3613 • 13 weeks 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 Herpes zoster oticus	0.03% 1/3613 • 13 weeks 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 Lung infection	0.03% 1/3613 • 13 weeks 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 Lymphangitis	0.03% 1/3613 • 13 weeks 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	0.17% 6/3613 • 13 weeks 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 Septic shock	0.03% 1/3613 • 13 weeks 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) Bile duct cancer	0.03% 1/3613 • 13 weeks 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) Gastric cancer	0.06% 2/3613 • 13 weeks 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	0.14% 5/3613 • 13 weeks 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) Neoplasm malignant	0.03% 1/3613 • 13 weeks 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) Oesophageal carcinoma	0.06% 2/3613 • 13 weeks 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) Rectal cancer	0.03% 1/3613 • 13 weeks 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 Disseminated intravascular coagulation	0.03% 1/3613 • 13 weeks 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 Decreased immune responsiveness	0.03% 1/3613 • 13 weeks 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	0.03% 1/3613 • 13 weeks 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 Hyperkalaemia	0.03% 1/3613 • 13 weeks 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 Hyponatraemia	0.03% 1/3613 • 13 weeks 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 Hallucination	0.03% 1/3613 • 13 weeks 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 Hallucination, auditory	0.03% 1/3613 • 13 weeks 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 Somatic symptom disorder	0.03% 1/3613 • 13 weeks 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 Suicide attempt	0.03% 1/3613 • 13 weeks 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 Altered state of consciousness	0.03% 1/3613 • 13 weeks 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 Carotid artery stenosis	0.03% 1/3613 • 13 weeks 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	0.03% 1/3613 • 13 weeks 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	0.03% 1/3613 • 13 weeks 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 Cerebrovascular accident	0.03% 1/3613 • 13 weeks 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 Depressed level of consciousness	0.03% 1/3613 • 13 weeks 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	0.30% 11/3613 • 13 weeks 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 Haemorrhagic cerebral infarction	0.03% 1/3613 • 13 weeks 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	0.03% 1/3613 • 13 weeks 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 Paraparesis	0.03% 1/3613 • 13 weeks 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 Radiculopathy	0.03% 1/3613 • 13 weeks 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	0.08% 3/3613 • 13 weeks 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 Conjunctival haemorrhage	0.03% 1/3613 • 13 weeks 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 Eyelid oedema	0.03% 1/3613 • 13 weeks 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 Retinal detachment	0.03% 1/3613 • 13 weeks 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 Acute myocardial infarction	0.03% 1/3613 • 13 weeks 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 unstable	0.06% 2/3613 • 13 weeks 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 Arrhythmia	0.03% 1/3613 • 13 weeks 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 Acute respiratory distress syndrome	0.03% 1/3613 • 13 weeks 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 Asthma	0.03% 1/3613 • 13 weeks 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 Chronic obstructive pulmonary disease	0.03% 1/3613 • 13 weeks 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 Haemoptysis	0.06% 2/3613 • 13 weeks 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 Respiratory disorder	0.03% 1/3613 • 13 weeks 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 Respiratory failure	0.03% 1/3613 • 13 weeks 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 Anorectal disorder	0.03% 1/3613 • 13 weeks 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	0.03% 1/3613 • 13 weeks 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 Gastrointestinal perforation	0.03% 1/3613 • 13 weeks 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 paralytic	0.03% 1/3613 • 13 weeks 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 Rectal haemorrhage	0.03% 1/3613 • 13 weeks 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 Liver disorder	0.03% 1/3613 • 13 weeks 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 Rash generalised	0.03% 1/3613 • 13 weeks 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 Bladder disorder	0.03% 1/3613 • 13 weeks 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 Dysuria	0.03% 1/3613 • 13 weeks 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	0.06% 2/3613 • 13 weeks 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	0.03% 1/3613 • 13 weeks 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 Urinary retention	0.03% 1/3613 • 13 weeks 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	0.03% 1/3613 • 13 weeks 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 Death	0.03% 1/3613 • 13 weeks 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	0.19% 7/3613 • 13 weeks 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 Drug interaction	0.03% 1/3613 • 13 weeks 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 Generalised oedema	0.03% 1/3613 • 13 weeks 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	0.03% 1/3613 • 13 weeks 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	0.06% 2/3613 • 13 weeks 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	0.03% 1/3613 • 13 weeks 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	0.11% 4/3613 • 13 weeks 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 Femur fracture	0.06% 2/3613 • 13 weeks 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 Humerus fracture	0.03% 1/3613 • 13 weeks 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	0.08% 3/3613 • 13 weeks 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 Thermal burn	0.03% 1/3613 • 13 weeks 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.
Product Issues Device breakage	0.03% 1/3613 • 13 weeks 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=3613 participants at risk Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 13 weeks at maximum. The dosage can be adjusted as per physician's discretion.
Blood and lymphatic system disorders Febrile neutropenia	0.03% 1/3613 • 13 weeks 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	0.06% 2/3613 • 13 weeks 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 Sinus bradycardia	0.03% 1/3613 • 13 weeks 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	0.75% 27/3613 • 13 weeks 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	0.03% 1/3613 • 13 weeks 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 Accommodation disorder	0.03% 1/3613 • 13 weeks 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 Dacryostenosis acquired	0.03% 1/3613 • 13 weeks 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	0.03% 1/3613 • 13 weeks 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 Diplopia	0.03% 1/3613 • 13 weeks 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 Photophobia	0.03% 1/3613 • 13 weeks 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 Photopsia	0.03% 1/3613 • 13 weeks 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	0.28% 10/3613 • 13 weeks 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 Visual acuity reduced	0.06% 2/3613 • 13 weeks 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	0.17% 6/3613 • 13 weeks 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	0.06% 2/3613 • 13 weeks 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 upper	0.08% 3/3613 • 13 weeks 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 Cheilitis	0.03% 1/3613 • 13 weeks 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	0.03% 1/3613 • 13 weeks 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	0.91% 33/3613 • 13 weeks 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	0.19% 7/3613 • 13 weeks 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 Dry mouth	0.03% 1/3613 • 13 weeks 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	0.08% 3/3613 • 13 weeks 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	0.03% 1/3613 • 13 weeks 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	0.14% 5/3613 • 13 weeks 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 Gastrooesophageal reflux disease	0.06% 2/3613 • 13 weeks 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 obstruction	0.03% 1/3613 • 13 weeks 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 Lip swelling	0.03% 1/3613 • 13 weeks 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	0.75% 27/3613 • 13 weeks 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 Oesophagitis	0.03% 1/3613 • 13 weeks 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 Oral pain	0.03% 1/3613 • 13 weeks 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	0.06% 2/3613 • 13 weeks 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	0.17% 6/3613 • 13 weeks 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	0.03% 1/3613 • 13 weeks 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	0.03% 1/3613 • 13 weeks 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 Chills	0.03% 1/3613 • 13 weeks 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 Discomfort	0.03% 1/3613 • 13 weeks 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	0.22% 8/3613 • 13 weeks 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 Feeling abnormal	0.30% 11/3613 • 13 weeks 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 Feeling hot	0.03% 1/3613 • 13 weeks 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 Gait disturbance	0.06% 2/3613 • 13 weeks 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 Loss of control of legs	0.03% 1/3613 • 13 weeks 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 Malaise	0.11% 4/3613 • 13 weeks 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	0.72% 26/3613 • 13 weeks 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 due to cardiac disease	0.06% 2/3613 • 13 weeks 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	1.0% 37/3613 • 13 weeks 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 Pain	0.06% 2/3613 • 13 weeks 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	0.03% 1/3613 • 13 weeks 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 Pyrexia	0.03% 1/3613 • 13 weeks 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	0.14% 5/3613 • 13 weeks 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 Hepatic function abnormal	0.08% 3/3613 • 13 weeks 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 Hypersensitivity	0.03% 1/3613 • 13 weeks 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	0.06% 2/3613 • 13 weeks 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	0.08% 3/3613 • 13 weeks 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	0.03% 1/3613 • 13 weeks 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	0.03% 1/3613 • 13 weeks 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	0.03% 1/3613 • 13 weeks 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	0.03% 1/3613 • 13 weeks 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	0.03% 1/3613 • 13 weeks 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	0.03% 1/3613 • 13 weeks 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 Pharyngotonsillitis	0.03% 1/3613 • 13 weeks 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	0.03% 1/3613 • 13 weeks 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 Urinary tract infection	0.03% 1/3613 • 13 weeks 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	0.17% 6/3613 • 13 weeks 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	0.06% 2/3613 • 13 weeks 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 Excoriation	0.03% 1/3613 • 13 weeks 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	0.08% 3/3613 • 13 weeks 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 Head injury	0.03% 1/3613 • 13 weeks 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	0.03% 1/3613 • 13 weeks 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	0.03% 1/3613 • 13 weeks 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	0.03% 1/3613 • 13 weeks 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	0.03% 1/3613 • 13 weeks 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	0.03% 1/3613 • 13 weeks 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 increased	0.03% 1/3613 • 13 weeks 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 pressure decreased	0.03% 1/3613 • 13 weeks 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 urea increased	0.03% 1/3613 • 13 weeks 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 Hepatic enzyme abnormal	0.03% 1/3613 • 13 weeks 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 Liver function test abnormal	0.03% 1/3613 • 13 weeks 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	0.03% 1/3613 • 13 weeks 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	0.53% 19/3613 • 13 weeks 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	0.03% 1/3613 • 13 weeks 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% 9/3613 • 13 weeks 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	0.08% 3/3613 • 13 weeks 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 Hyperkalaemia	0.03% 1/3613 • 13 weeks 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 Hypoglycaemia	0.03% 1/3613 • 13 weeks 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 Increased appetite	0.06% 2/3613 • 13 weeks 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	0.06% 2/3613 • 13 weeks 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 Back pain	0.03% 1/3613 • 13 weeks 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	0.03% 1/3613 • 13 weeks 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	0.03% 1/3613 • 13 weeks 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 Muscular weakness	0.03% 1/3613 • 13 weeks 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 Musculoskeletal stiffness	0.06% 2/3613 • 13 weeks 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	0.03% 1/3613 • 13 weeks 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	0.06% 2/3613 • 13 weeks 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	0.06% 2/3613 • 13 weeks 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 Rotator cuff syndrome	0.03% 1/3613 • 13 weeks 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	0.11% 4/3613 • 13 weeks 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 Altered state of consciousness	0.03% 1/3613 • 13 weeks 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 Amnesia	0.03% 1/3613 • 13 weeks 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	0.03% 1/3613 • 13 weeks 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 Dementia	0.03% 1/3613 • 13 weeks 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 Depressed level of consciousness	0.03% 1/3613 • 13 weeks 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	6.5% 235/3613 • 13 weeks 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 postural	0.19% 7/3613 • 13 weeks 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 Dysarthria	0.03% 1/3613 • 13 weeks 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 Dyskinesia	0.03% 1/3613 • 13 weeks 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 Dysstasia	0.03% 1/3613 • 13 weeks 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 Headache	0.28% 10/3613 • 13 weeks 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 Hyperaesthesia	0.03% 1/3613 • 13 weeks 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	0.06% 2/3613 • 13 weeks 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	0.03% 1/3613 • 13 weeks 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 Monoplegia	0.03% 1/3613 • 13 weeks 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 Myoclonus	0.03% 1/3613 • 13 weeks 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 Neuroleptic malignant syndrome	0.03% 1/3613 • 13 weeks 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 Radicular pain	0.03% 1/3613 • 13 weeks 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 Sciatica	0.03% 1/3613 • 13 weeks 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	3.7% 134/3613 • 13 weeks 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 Transient ischaemic attack	0.03% 1/3613 • 13 weeks 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 Tremor	0.08% 3/3613 • 13 weeks 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 Anxiety	0.03% 1/3613 • 13 weeks 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 Delirium	0.06% 2/3613 • 13 weeks 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 Depression	0.08% 3/3613 • 13 weeks 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 Hallucination, auditory	0.03% 1/3613 • 13 weeks 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	0.19% 7/3613 • 13 weeks 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	0.03% 1/3613 • 13 weeks 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 Dysuria	0.06% 2/3613 • 13 weeks 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 Haematuria	0.03% 1/3613 • 13 weeks 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 Pollakiuria	0.03% 1/3613 • 13 weeks 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	0.11% 4/3613 • 13 weeks 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 Ureterolithiasis	0.03% 1/3613 • 13 weeks 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 Urinary incontinence	0.03% 1/3613 • 13 weeks 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 Urinary retention	0.03% 1/3613 • 13 weeks 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 Apnoea	0.03% 1/3613 • 13 weeks 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	0.03% 1/3613 • 13 weeks 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 Oropharyngeal pain	0.03% 1/3613 • 13 weeks 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 Pneumonia aspiration	0.06% 2/3613 • 13 weeks 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	0.03% 1/3613 • 13 weeks 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	0.03% 1/3613 • 13 weeks 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 Decubitus ulcer	0.03% 1/3613 • 13 weeks 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	0.06% 2/3613 • 13 weeks 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 Drug eruption	0.06% 2/3613 • 13 weeks 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	0.03% 1/3613 • 13 weeks 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 Haemorrhage subcutaneous	0.03% 1/3613 • 13 weeks 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	0.06% 2/3613 • 13 weeks 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	0.08% 3/3613 • 13 weeks 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 Rash	0.08% 3/3613 • 13 weeks 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	0.03% 1/3613 • 13 weeks 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	0.03% 1/3613 • 13 weeks 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 Urticaria	0.08% 3/3613 • 13 weeks 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	0.11% 4/3613 • 13 weeks 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	0.11% 4/3613 • 13 weeks 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 Phlebitis	0.03% 1/3613 • 13 weeks 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

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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