Trial Outcomes & Findings for Special Investigation of Pregabalin for Fibromyalgia (Regulatory Post Marketing Commitment Plan) (NCT NCT01773993)

NCT ID: NCT01773993

Last Updated: 2023-10-10

Results Overview

Recruitment status

COMPLETED

Target enrollment

534 participants

Primary outcome timeframe

From Week 1 to 52 weeks at maximum

Results posted on

2023-10-10

Participant Flow

Participant milestones

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 52 weeks at maximum. The dosage can be adjusted as per physician's discretion.
Overall Study STARTED	534
Overall Study COMPLETED	499
Overall Study NOT COMPLETED	35

Reasons for withdrawal

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 52 weeks at maximum. The dosage can be adjusted as per physician's discretion.
Overall Study No Visit After Treatment	35

Baseline Characteristics

Special Investigation of Pregabalin for Fibromyalgia (Regulatory Post Marketing Commitment Plan)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LYRICA Capsules (Pregabalin) n=499 Participants Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 52 weeks at maximum. The dosage can be adjusted as per physician's discretion.
Age, Customized <15 years	1 Participants n=99 Participants
Age, Customized ≥15 and <65 years	392 Participants n=99 Participants
Age, Customized ≥65 years	106 Participants n=99 Participants
Sex/Gender, Customized Male	91 Participants n=99 Participants
Sex/Gender, Customized Female	408 Participants n=99 Participants
Race/Ethnicity, Customized Race and Ethnicity Not Collected	499 Participants n=99 Participants

PRIMARY outcome

Timeframe: From Week 1 to 52 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.

Outcome measures

Outcome measures
Measure	LYRICA Capsules (Pregabalin) n=499 Participants Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 52 weeks at maximum. The dosage can be adjusted as per physician's discretion.
Percentage of Participants With Adverse Drug Reaction	25.45 Percentage of Participants

SECONDARY outcome

Timeframe: From Week 1 to52 weeks

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

Outcome measures
Measure	LYRICA Capsules (Pregabalin) n=499 Participants Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 52 weeks at maximum. The dosage can be adjusted as per physician's discretion.
Percentage of Participants With Serious Adverse Drug Reaction	0.20 Percentage of Participants

SECONDARY outcome

Timeframe: From Week 1 to 52 weeks

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

Outcome measures
Measure	LYRICA Capsules (Pregabalin) n=499 Participants Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 52 weeks at maximum. The dosage can be adjusted as per physician's discretion.
Percentage of Participants With Adverse Drug Reaction Unexpected From Japanese Package Insert	3.41 Percentage of Participants

SECONDARY outcome

Timeframe: From Week 1 to 52 weeks

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

Outcome measures
Measure	LYRICA Capsules (Pregabalin) n=499 Participants Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 52 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	6 Participants

SECONDARY outcome

Timeframe: From Week 1 to 52 weeks

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

Outcome measures
Measure	LYRICA Capsules (Pregabalin) n=499 Participants Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 52 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	65 Participants

SECONDARY outcome

Timeframe: From Week 1 to 52 weeks

Outcome measures

Outcome measures
Measure	LYRICA Capsules (Pregabalin) n=499 Participants Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 52 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	5 Participants

SECONDARY outcome

Timeframe: Baseline and at Week 52

Population: The analysis population for this outcome measure comprised of participants for whom the evaluation outcome of pain score was available among the baseline analysis population.

The pain from fibromyalgia experienced 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 the pain score at Week 52 was presented along with standard deviation.

Outcome measures

Outcome measures
Measure	LYRICA Capsules (Pregabalin) n=182 Participants Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 52 weeks at maximum. The dosage can be adjusted as per physician's discretion.
Change From Baseline in Pain Score at Week 52	-2.4 Units on a scale Standard Deviation 2.67

SECONDARY outcome

Timeframe: Baseline and at Week 52

Population: The analysis population for this outcome measure comprised of participants for whom the evaluation outcome of quality of sleep score was available among the baseline analysis population.

The quality of sleep experienced 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 (the best sleep possible) to 10 (the worst sleep possible). Mean change from baseline in quality of sleep score at Week 52 was presented along with standard deviation.

Outcome measures

Outcome measures
Measure	LYRICA Capsules (Pregabalin) n=163 Participants Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 52 weeks at maximum. The dosage can be adjusted as per physician's discretion.
Change From Baseline in Quality of Sleep Score at Week 52	-1.4 Units on a scale Standard Deviation 2.71

SECONDARY outcome

Timeframe: At Week 52

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

The patient's impression (patient global impression of change \[PGIC\]) at Week 52, as compared to the baseline condition (including the first day of treatment), was rated by participants on a 7-grade scale.

Outcome measures

Outcome measures
Measure	LYRICA Capsules (Pregabalin) n=416 Participants Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 52 weeks at maximum. The dosage can be adjusted as per physician's discretion.
Patient's Impression (PGIC) at Week 52 Markedly improved	34 Participants
Patient's Impression (PGIC) at Week 52 Improved	79 Participants
Patient's Impression (PGIC) at Week 52 Slightly improved	119 Participants
Patient's Impression (PGIC) at Week 52 Unchanged	65 Participants
Patient's Impression (PGIC) at Week 52 Slightly worsened	6 Participants
Patient's Impression (PGIC) at Week 52 Worsened	3 Participants
Patient's Impression (PGIC) at Week 52 Markedly worsened	1 Participants
Patient's Impression (PGIC) at Week 52 Not assessed	109 Participants

SECONDARY outcome

Timeframe: At Week 52

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

The physician's impression (clinical global impression of change \[CGIC\]) at Week 52, as compared to the baseline condition (including the first day of treatment), was rated by the physician on a 7-grade scale.

Outcome measures

Outcome measures
Measure	LYRICA Capsules (Pregabalin) n=409 Participants Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 52 weeks at maximum. The dosage can be adjusted as per physician's discretion.
Physician's Impression (CGIC) at Week 52 Markedly improved	45 Participants
Physician's Impression (CGIC) at Week 52 Improved	105 Participants
Physician's Impression (CGIC) at Week 52 Slightly improved	121 Participants
Physician's Impression (CGIC) at Week 52 Unchanged	59 Participants
Physician's Impression (CGIC) at Week 52 Slightly worsened	4 Participants
Physician's Impression (CGIC) at Week 52 Worsened	2 Participants
Physician's Impression (CGIC) at Week 52 Markedly worsened	1 Participants
Physician's Impression (CGIC) at Week 52 Not assessed	72 Participants

SECONDARY outcome

Timeframe: Baseline and at Week 52

Population: The analysis population for this outcome measure comprised of participants for whom the evaluation outcome of PHQ-9 was available among the baseline analysis population.

The problems associated with depression-related symptoms experienced during the last 2 weeks were rated by participants ranging from 0 (not at all) to 3 (nearly every day) in total 0 to 27(the higher the more severe) consisting the following 9 items: 1) little interest or pleasure in doing things; 2) depressed, or hopeless; 3) trouble falling or staying asleep, or sleeping too much; 4) feeling tired or having little energy; 5) poor appetite or overeating; 6) feeling bad about yourself - or that you are a failure or have let yourself or your family down; 7) trouble concentrating on things, such as reading the newspaper or watching television; 8) moving or speaking so slowly that other people could have noticed. Or the opposite - being so fidgety or restless that you have been moving around a lot more than usual; and 9) thoughts that you would be better off dead, or of hurting yourself. Mean change from baseline in the evaluation score was presented along with standard deviation.

Outcome measures

Outcome measures
Measure	LYRICA Capsules (Pregabalin) n=161 Participants Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 52 weeks at maximum. The dosage can be adjusted as per physician's discretion.
Change From Baseline in Patient Health Questionnaire (PHQ-9) Score at Week 52	-3.4 Units on a scale Standard Deviation 6.91

SECONDARY outcome

Timeframe: Baseline and at Week 52

Population: The analysis population for this outcome measure comprised of participants for whom the evaluation outcome of EQ-5D was available among the baseline analysis population.

Health status (EQ-5D) was evaluated based on the following 5 dimensions: mobility, self-care, usual activity (e.g., work, study, housework, family, or leisure activities), pain/discomfort, and anxiety/depression. Each dimension was rated in the three levels of response alternatives "no problems," "some problems," or "extreme problems." For the analysis of EQ-5D, the response outcome for the five dimensions was converted to a utility value using tariff value set based on the Japanese version of EQ-5D. The utility value was not assigned if there was no response in any one of the five dimensions. 1 for full health and 0 for being dead: a positive (negative) number implies that the health state is better (worse) than dead. Mean change from baseline in the evaluation score was presented along with standard deviation.

Outcome measures

Outcome measures
Measure	LYRICA Capsules (Pregabalin) n=162 Participants Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 52 weeks at maximum. The dosage can be adjusted as per physician's discretion.
Change From Baseline in Health Status of EuroQol 5 Dimension (EQ-5D) at 52 Weeks	0.1 Units on a scale Standard Deviation 0.19

SECONDARY outcome

Timeframe: At Week 52

Population: The analysis population for this outcome measure comprised of participants for whom the evaluation outcome of FAS-31 was available among the baseline analysis population.

FAS-31 (ranged from 0 to 31) is calculated as the combined score of the widespread pain index (WPI, ranged from 0 to 19) and the symptom severity (SS) scale (ranged from 0 to 12). The WPI is a measure of the number of painful body regions. The SS is the scale of the severity in the three symptoms (fatigue, waking unrefreshed, and cognitive symptoms; ranged from 0 to 3 each) and general physical symptoms (ranged from 0 to 3). WPI ranged from 0 to 19 the higher score indicates more severe of activity, SS ranged from 0-12 also higher score shows more severe symptoms observed. Mean change from baseline in the evaluation score was presented along with standard deviation.

Outcome measures

Outcome measures
Measure	LYRICA Capsules (Pregabalin) n=175 Participants Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 52 weeks at maximum. The dosage can be adjusted as per physician's discretion.
Change From Baseline in Fibromyalgia Activity Score (FAS-31) at 52 Weeks	-5.2 Units on a scale Standard Deviation 6.15

SECONDARY outcome

Timeframe: At Week 52

Population: The analysis population for this outcome measure comprised of participants for whom the evaluation outcome of JFIQR was available among the baseline analysis population.

JFIQR is a Japanese version of the Revised Fibromyalgia Impact Questionnaire (FIQR), which was established for overall evaluation of the influence of fibromyalgia on patient's health. It consists of three linked sets of domains: "function (9 questions)," "overall impact (2 questions)," and "symptoms (10 questions)." Participants responded to the questions based on an 11-grade scale, ranging from 0 to 10, with 10 being the worst. For the analysis of JFIQR, the score for each domain was modified as follows: The summed score for "function" (ranged from 0 to 90) was divided by 3 and the summed score for "symptoms" (ranged from 0 to 100) was divided by 2. The summed score for "overall impact" (ranged from 0 to 20) was not modified. The total score, the sum of the three modified domain scores (ranged from 0 to 100, the lower score represents a better outcome), was used for the analysis. Mean change from baseline in the evaluation score was presented along with standard deviation.

Outcome measures

Outcome measures
Measure	LYRICA Capsules (Pregabalin) n=137 Participants Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 52 weeks at maximum. The dosage can be adjusted as per physician's discretion.
Change From Baseline in the Japanese Version of the Revised Fibromyalgia Impact Questionnaire (JFIQR) at 52 Weeks	-15.2 Units on a scale Standard Deviation 23.18

Adverse Events

LYRICA Capsules (Pregabalin)

Serious events: 4 serious events

Other events: 152 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	LYRICA Capsules (Pregabalin) n=499 participants at risk Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 52 weeks at maximum. The dosage can be adjusted as per physician's discretion.
Infections and infestations Pneumonia bacterial	0.20% 1/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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	0.20% 1/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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	0.20% 1/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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 Stevens-Johnson syndrome	0.20% 1/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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

Other adverse events
Measure	LYRICA Capsules (Pregabalin) n=499 participants at risk Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 52 weeks at maximum. The dosage can be adjusted as per physician's discretion.
Blood and lymphatic system disorders Anaemia	0.40% 2/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Cardiac disorders Palpitations	0.40% 2/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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 Meniere's disease	0.20% 1/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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	0.20% 1/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Endocrine disorders Hyperprolactinaemia	0.20% 1/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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 Foreign body sensation in eyes	0.20% 1/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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	0.60% 3/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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	0.20% 1/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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	0.80% 4/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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 distension	0.20% 1/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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	0.40% 2/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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	0.20% 1/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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	2.6% 13/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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	0.20% 1/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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	0.20% 1/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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	1.0% 5/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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 disorder	0.40% 2/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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	0.40% 2/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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 blister	0.20% 1/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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	2.2% 11/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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	0.20% 1/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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	0.20% 1/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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	0.60% 3/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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 cold	0.20% 1/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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	0.60% 3/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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	0.60% 3/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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	0.80% 4/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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	0.80% 4/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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	1.6% 8/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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	0.20% 1/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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 Gastroenteritis bacterial	0.20% 1/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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	0.20% 1/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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 chlamydial	0.20% 1/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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	0.20% 1/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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	0.20% 1/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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	0.20% 1/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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	0.20% 1/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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 triglycerides increased	0.20% 1/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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 Lipids abnormal	0.20% 1/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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	3.6% 18/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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	0.60% 3/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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	0.20% 1/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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 Dyslipidaemia	0.20% 1/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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 Hypocalcaemia	0.20% 1/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Musculoskeletal and connective tissue disorders Arthralgia	0.20% 1/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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 Fibromyalgia	0.20% 1/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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 Intervertebral disc disorder	0.20% 1/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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 Intervertebral disc protrusion	0.20% 1/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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	0.20% 1/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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 Muscle rigidity	0.20% 1/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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 Muscle spasms	0.20% 1/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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	0.40% 2/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Musculoskeletal and connective tissue disorders Neck pain	0.20% 1/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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	0.20% 1/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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	0.20% 1/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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 Rheumatoid arthritis	0.20% 1/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.20% 1/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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	0.20% 1/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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 Autonomic nervous system imbalance	0.20% 1/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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 Cognitive disorder	0.20% 1/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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 Disturbance in attention	0.20% 1/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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	7.6% 38/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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	0.20% 1/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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	0.80% 4/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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	0.20% 1/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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 Memory impairment	0.40% 2/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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 Restless legs syndrome	0.20% 1/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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	7.6% 38/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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 Affect lability	0.20% 1/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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 Anger	0.20% 1/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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 disorder	0.40% 2/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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	1.2% 6/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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	1.6% 8/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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 Mania	0.60% 3/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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	0.40% 2/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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 discomfort	0.20% 1/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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	0.20% 1/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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 Erythema	0.20% 1/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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	0.20% 1/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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	0.20% 1/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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	0.20% 1/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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 Swelling face	0.20% 1/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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	0.40% 2/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 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 Peripheral vascular disorder	0.20% 1/499 • 52 weeks The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

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