Trial Outcomes & Findings for Self-Selection and Actual Use Trial of Ibuprofen 600 mg Immediate Release/Extended Caplet (NCT NCT01789606)

Last Updated: 2017-08-28

Results Overview

Participants as correct selectors included all participants who selected Ibuprofen 600 mg IR/ER medication with the last episode of pain of \>=6 hours, if left untreated. Participants as correct de-selectors included all participants who either selected Ibuprofen 200 mg or selected 'neither' with a typical pain duration of less than (\<) 6 hours, if left untreated.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1083 participants

Primary outcome timeframe

Day 1

Results posted on

2017-08-28

Participant Flow

Participant milestones

Participant milestones
Measure	Self-Selection Arm Participants who were enrolled in the self-selection arm and completed the self-selection questionnaire were made to either select or deselect Ibuprofen 200 milligram (mg) immediate release (IR) or 600 mg IR or extended release (ER) tablets, or to deselect both the products based on their current painful condition. Participants enrolled in this arm did not receive any study medication.	Compliance Arm Participants enrolled in compliance arm, received at least one dose of 600 mg IR or ER tablet of Ibuprofen over a period of 30 days and returned the diary cards, or if any information on dosing was available.
Overall Study STARTED	251	832
Overall Study COMPLETED	228	382
Overall Study NOT COMPLETED	23	450

Reasons for withdrawal

Reasons for withdrawal
Measure	Self-Selection Arm Participants who were enrolled in the self-selection arm and completed the self-selection questionnaire were made to either select or deselect Ibuprofen 200 milligram (mg) immediate release (IR) or 600 mg IR or extended release (ER) tablets, or to deselect both the products based on their current painful condition. Participants enrolled in this arm did not receive any study medication.	Compliance Arm Participants enrolled in compliance arm, received at least one dose of 600 mg IR or ER tablet of Ibuprofen over a period of 30 days and returned the diary cards, or if any information on dosing was available.
Overall Study Participant not Purchased the Product	0	20
Overall Study Withdrawal by Subject	0	1
Overall Study Ineligible	6	2
Overall Study Administrative Reasons	17	6
Overall Study No Study Medication Taken	0	1
Overall Study Protocol Violation	0	55
Overall Study Adverse Event	0	3
Overall Study Lost to Follow-up	0	14
Overall Study Ineligible or not Willing to Continue	0	348

Baseline Characteristics

Self-Selection and Actual Use Trial of Ibuprofen 600 mg Immediate Release/Extended Caplet

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Self-Selection Arm n=251 Participants Participants who were enrolled in the self-selection arm and completed the self-selection questionnaire were made to either select or deselect Ibuprofen 200 milligram (mg) immediate release (IR) or 600 mg IR or extended release (ER) tablets, or to deselect both the products based on their current painful condition. Participants enrolled in this arm did not receive any study medication.	Compliance Arm n=832 Participants Participants enrolled in compliance arm, received at least one dose of 600 mg IR or ER tablet of Ibuprofen over a period of 30 days and returned the diary cards, or if any information on dosing was available.	Total n=1083 Participants Total of all reporting groups
Age, Customized Unknown	2 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants
Sex/Gender, Customized Female	114 participants n=5 Participants	408 participants n=7 Participants	522 participants n=5 Participants
Age, Customized Less Than (<)18 years	2 participants n=5 Participants	5 participants n=7 Participants	7 participants n=5 Participants
Age, Customized Greater Than or Equal to (>=) 18 years	247 participants n=5 Participants	827 participants n=7 Participants	1074 participants n=5 Participants
Sex/Gender, Customized Male	114 participants n=5 Participants	403 participants n=7 Participants	517 participants n=5 Participants
Sex/Gender, Customized Unknown	23 participants n=5 Participants	21 participants n=7 Participants	44 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1

Outcome measures

Outcome measures
Measure	Self-Selection Arm n=249 Participants Participants who were enrolled in the self-selection arm and completed the self-selection questionnaire were made to either select or deselect Ibuprofen 200 milligram (mg) immediate release (IR) or 600 mg IR or extended release (ER) tablets, or to deselect both the products based on their current painful condition. Participants enrolled in this arm did not receive any study medication.
Percentage of Participants Who Correctly Select to Use or Correctly De-select Not to Use Ibuprofen 600 Milligram (mg) Immediate Release (IR) or Extended Release (ER) Study Medication	69.1 percentage of participants Interval 63.3 to 74.8

PRIMARY outcome

Timeframe: Day 1

Population: This outcome measure was not planned to be analysed in compliance arm. Analysis population included all participants enrolled in the self-selection arm of the study and completed the self-selection questionnaire. Here, 'Number of Participants Analyzed (N)' signifies participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Self-Selection Arm n=208 Participants Participants who were enrolled in the self-selection arm and completed the self-selection questionnaire were made to either select or deselect Ibuprofen 200 milligram (mg) immediate release (IR) or 600 mg IR or extended release (ER) tablets, or to deselect both the products based on their current painful condition. Participants enrolled in this arm did not receive any study medication.
Percentage of Participants Who Correctly Select to Use or Correctly De-select Not to Use Ibuprofen 600 mg IR/ER Study Medication Excluding Those Classified as Missed Opportunity	82.7 percentage of participants Interval 77.6 to 87.8

PRIMARY outcome

Timeframe: Day 1

Population: This outcome measure was not planned to be analysed in compliance arm. Analysis population included all participants enrolled in the self-selection arm of the study and completed the self-selection questionnaire. Here, 'N' signifies participants evaluable for this outcome measure.

Percentage of participants with correct selection of Ibuprofen 600 mg IR/ER medication with a typical duration of pain \<6 hours were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Self-Selection Arm n=38 Participants Participants who were enrolled in the self-selection arm and completed the self-selection questionnaire were made to either select or deselect Ibuprofen 200 milligram (mg) immediate release (IR) or 600 mg IR or extended release (ER) tablets, or to deselect both the products based on their current painful condition. Participants enrolled in this arm did not receive any study medication.
Percentage of Participants Who Select to Use Ibuprofen 600 mg IR/ER Medication With a Typical Pain Duration of Less Than (<) 6 Hours	63.2 percentage of participants Interval 47.8 to 78.5

PRIMARY outcome

Timeframe: Day 1

Population: This outcome measure was not planned to be analysed in compliance arm. Analysis population included all participants enrolled in the self-selection arm of the study and completed the self-selection questionnaire. Here, 'N' signifies participants evaluable for this outcome measure.

Percentage of participants with selection of Ibuprofen 200 mg IR medication with a typical duration of pain \>=6 hours were reported in this outcome measure. These participants were classified as ''missed opportunity'' cases.

Outcome measures

Outcome measures
Measure	Self-Selection Arm n=211 Participants Participants who were enrolled in the self-selection arm and completed the self-selection questionnaire were made to either select or deselect Ibuprofen 200 milligram (mg) immediate release (IR) or 600 mg IR or extended release (ER) tablets, or to deselect both the products based on their current painful condition. Participants enrolled in this arm did not receive any study medication.
Percentage of Participants Who Select to Use Ibuprofen 200 mg IR Medication With a Typical Pain Duration of Greater Than or Equal to (>=) 6 Hours	20.9 percentage of participants Interval 15.4 to 26.3

PRIMARY outcome

Timeframe: Day 1 up to Day 30

Population: This outcome measure was not planned to be analysed in self-selection arm. Analysis population included all participants of compliance arm who received at least 1 dose of the study drug during the 30 days and returned the completed study diary, or any information on dosing which was available.

Percentage of participants with the use of study medication for \>10 days with an average daily dose of \>1600 mg were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Self-Selection Arm n=403 Participants Participants who were enrolled in the self-selection arm and completed the self-selection questionnaire were made to either select or deselect Ibuprofen 200 milligram (mg) immediate release (IR) or 600 mg IR or extended release (ER) tablets, or to deselect both the products based on their current painful condition. Participants enrolled in this arm did not receive any study medication.
Percentage of Participants With the Use of Study Medication For Greater Than (>) 10 Days With an Average Daily Dose of Greater Than (>) 1600 mg	1.2 percentage of participants Interval 0.2 to 2.3

PRIMARY outcome

Timeframe: Day 1 up to Day 30

Percentage of participants who used the study medication for \<=10 days and used more than 20 tablets with an average daily dose of \>1600 mg were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Self-Selection Arm n=403 Participants Participants who were enrolled in the self-selection arm and completed the self-selection questionnaire were made to either select or deselect Ibuprofen 200 milligram (mg) immediate release (IR) or 600 mg IR or extended release (ER) tablets, or to deselect both the products based on their current painful condition. Participants enrolled in this arm did not receive any study medication.
Percentage of Participants With the Use of Study Medication For Less Than or Equal to (<=) 10 Days and Use More Than 20 Tablets With an Average Daily Dose of Greater Than (>) 1600 mg	0 percentage of participants Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Day 1 up to Day 30

Excessive users included all participants who used the study medication for more than 10 days (not necessarily consecutive) during study period with an average daily dose of \>1600 mg or all participants who used the study medication for \<=10 days during study period, used more than 20 tablets and had an average daily dose of \>1600 mg.

Outcome measures

Outcome measures
Measure	Self-Selection Arm n=5 Participants Participants who were enrolled in the self-selection arm and completed the self-selection questionnaire were made to either select or deselect Ibuprofen 200 milligram (mg) immediate release (IR) or 600 mg IR or extended release (ER) tablets, or to deselect both the products based on their current painful condition. Participants enrolled in this arm did not receive any study medication.
Average Daily Dose Among Excessive Users	1821.1 milligram Standard Deviation 157.4

SECONDARY outcome

Timeframe: Day 1 up to Day 30

Participants were considered as inappropriate users if they improperly used the study medication in their last pain episode duration of \<6 hours, if left untreated, based on the information provided at the follow up interview.

Outcome measures

Outcome measures
Measure	Self-Selection Arm n=45 Participants Participants who were enrolled in the self-selection arm and completed the self-selection questionnaire were made to either select or deselect Ibuprofen 200 milligram (mg) immediate release (IR) or 600 mg IR or extended release (ER) tablets, or to deselect both the products based on their current painful condition. Participants enrolled in this arm did not receive any study medication.
Number of Dosing Days Among Inappropriate Users	14.8 days Standard Deviation 8.1

SECONDARY outcome

Timeframe: Day 1 up to Day 30

In this outcome measure, number of pain episodes treated with single dose or multiple dose per day among inappropriate users were reported. Participants were considered as inappropriate users if they improperly used the study medication in their last pain episode duration of \<6 hours, based on the information provided at the follow up interview.

Outcome measures

Outcome measures
Measure	Self-Selection Arm n=45 Participants Participants who were enrolled in the self-selection arm and completed the self-selection questionnaire were made to either select or deselect Ibuprofen 200 milligram (mg) immediate release (IR) or 600 mg IR or extended release (ER) tablets, or to deselect both the products based on their current painful condition. Participants enrolled in this arm did not receive any study medication.
Number of Pain Episodes Treated With Single Dose or Multiple Dose Among Inappropriate Users Single dose	13.1 pain episodes Standard Deviation 7.4
Number of Pain Episodes Treated With Single Dose or Multiple Dose Among Inappropriate Users Multiple dose	1.8 pain episodes Standard Deviation 2.6

SECONDARY outcome

Timeframe: Day 1 up to Day 30

Number of treatment days when participants exceeded the daily dose of 1200 milligram were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Self-Selection Arm n=403 Participants Participants who were enrolled in the self-selection arm and completed the self-selection questionnaire were made to either select or deselect Ibuprofen 200 milligram (mg) immediate release (IR) or 600 mg IR or extended release (ER) tablets, or to deselect both the products based on their current painful condition. Participants enrolled in this arm did not receive any study medication.
Number of Treatment Days Exceeding the Daily Dose of 1200 Milligram	0.31 days Standard Deviation 1.188

SECONDARY outcome

Timeframe: Day 1 up to Day 30

In this outcome measure, number of treatment days exceeding the daily dose of 1200 mg, excluding the days when severe symptoms were treated, were reported.

Outcome measures

Outcome measures
Measure	Self-Selection Arm n=403 Participants Participants who were enrolled in the self-selection arm and completed the self-selection questionnaire were made to either select or deselect Ibuprofen 200 milligram (mg) immediate release (IR) or 600 mg IR or extended release (ER) tablets, or to deselect both the products based on their current painful condition. Participants enrolled in this arm did not receive any study medication.
Number of Treatment Days Exceeding the Daily Dose of 1200 Milligram Excluding Treatment of Severe Symptoms	0.12 days Standard Deviation 0.637

SECONDARY outcome

Timeframe: Day 1 up to Day 30

In this outcome measure, number of dosing occasions exceeding the single dose of 600 mg were reported.

Outcome measures

Outcome measures
Measure	Self-Selection Arm n=403 Participants Participants who were enrolled in the self-selection arm and completed the self-selection questionnaire were made to either select or deselect Ibuprofen 200 milligram (mg) immediate release (IR) or 600 mg IR or extended release (ER) tablets, or to deselect both the products based on their current painful condition. Participants enrolled in this arm did not receive any study medication.
Number of Dosing Occasions Exceeding the Single Dose of 600 Milligram	1.48 dosing occasions Standard Deviation 4.185

SECONDARY outcome

Timeframe: Day 1 up to Day 30

In this outcome measure, number of dosing occasions exceeding the single dose of 600 mg, excluding the events when severe symptoms were treated, were reported.

Outcome measures

Outcome measures
Measure	Self-Selection Arm n=403 Participants Participants who were enrolled in the self-selection arm and completed the self-selection questionnaire were made to either select or deselect Ibuprofen 200 milligram (mg) immediate release (IR) or 600 mg IR or extended release (ER) tablets, or to deselect both the products based on their current painful condition. Participants enrolled in this arm did not receive any study medication.
Number of Dosing Occasions Exceeding the Single Dose of 600 Milligram Excluding Treatment of Severe Symptoms	0.83 dosing occasions Standard Deviation 3.020

SECONDARY outcome

Timeframe: Day 1 up to Day 30

Outcome measures

Outcome measures
Measure	Self-Selection Arm n=403 Participants Participants who were enrolled in the self-selection arm and completed the self-selection questionnaire were made to either select or deselect Ibuprofen 200 milligram (mg) immediate release (IR) or 600 mg IR or extended release (ER) tablets, or to deselect both the products based on their current painful condition. Participants enrolled in this arm did not receive any study medication.
Average Daily Dose of Study Medication	781.0 milligram Standard Deviation 229.3

SECONDARY outcome

Timeframe: Day 1 up to Day 30

Outcome measures

Outcome measures
Measure	Self-Selection Arm n=403 Participants Participants who were enrolled in the self-selection arm and completed the self-selection questionnaire were made to either select or deselect Ibuprofen 200 milligram (mg) immediate release (IR) or 600 mg IR or extended release (ER) tablets, or to deselect both the products based on their current painful condition. Participants enrolled in this arm did not receive any study medication.
Maximum Daily Dose of Study Medication	1147.9 milligram Standard Deviation 604.43

Adverse Events

Compliance Arm

Serious events: 1 serious events

Other events: 163 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Compliance Arm n=405 participants at risk Participants enrolled in compliance arm, received at least one dose of 600 mg IR or ER tablet of Ibuprofen over a period of 30 days and returned the diary cards, or if any information on dosing was available.
Infections and infestations Pleural infection	0.25% 1/405 Safety data collected for all participants who received at least 1 dose of study drug(safety population).Same event may appear as AE and SAE.However,distinct events are presented.An event may categorized as serious in 1 participant and as nonserious in other participant,or 1 participant may experience both serious and nonserious event during study.

Other adverse events

Other adverse events
Measure	Compliance Arm n=405 participants at risk Participants enrolled in compliance arm, received at least one dose of 600 mg IR or ER tablet of Ibuprofen over a period of 30 days and returned the diary cards, or if any information on dosing was available.
Ear and labyrinth disorders Ear pain	0.49% 2/405 Safety data collected for all participants who received at least 1 dose of study drug(safety population).Same event may appear as AE and SAE.However,distinct events are presented.An event may categorized as serious in 1 participant and as nonserious in other participant,or 1 participant may experience both serious and nonserious event during study.
Eye disorders Vision blurred	0.25% 1/405 Safety data collected for all participants who received at least 1 dose of study drug(safety population).Same event may appear as AE and SAE.However,distinct events are presented.An event may categorized as serious in 1 participant and as nonserious in other participant,or 1 participant may experience both serious and nonserious event during study.
Eye disorders Visual acuity reduced	0.25% 1/405 Safety data collected for all participants who received at least 1 dose of study drug(safety population).Same event may appear as AE and SAE.However,distinct events are presented.An event may categorized as serious in 1 participant and as nonserious in other participant,or 1 participant may experience both serious and nonserious event during study.
Gastrointestinal disorders Abdominal discomfort	0.49% 2/405 Safety data collected for all participants who received at least 1 dose of study drug(safety population).Same event may appear as AE and SAE.However,distinct events are presented.An event may categorized as serious in 1 participant and as nonserious in other participant,or 1 participant may experience both serious and nonserious event during study.
Gastrointestinal disorders Abdominal pain	0.25% 1/405 Safety data collected for all participants who received at least 1 dose of study drug(safety population).Same event may appear as AE and SAE.However,distinct events are presented.An event may categorized as serious in 1 participant and as nonserious in other participant,or 1 participant may experience both serious and nonserious event during study.
Gastrointestinal disorders Abdominal pain upper	1.5% 6/405 Safety data collected for all participants who received at least 1 dose of study drug(safety population).Same event may appear as AE and SAE.However,distinct events are presented.An event may categorized as serious in 1 participant and as nonserious in other participant,or 1 participant may experience both serious and nonserious event during study.
Gastrointestinal disorders Constipation	0.25% 1/405 Safety data collected for all participants who received at least 1 dose of study drug(safety population).Same event may appear as AE and SAE.However,distinct events are presented.An event may categorized as serious in 1 participant and as nonserious in other participant,or 1 participant may experience both serious and nonserious event during study.
Gastrointestinal disorders Diarrhoea	0.74% 3/405 Safety data collected for all participants who received at least 1 dose of study drug(safety population).Same event may appear as AE and SAE.However,distinct events are presented.An event may categorized as serious in 1 participant and as nonserious in other participant,or 1 participant may experience both serious and nonserious event during study.
Gastrointestinal disorders Dyspepsia	0.49% 2/405 Safety data collected for all participants who received at least 1 dose of study drug(safety population).Same event may appear as AE and SAE.However,distinct events are presented.An event may categorized as serious in 1 participant and as nonserious in other participant,or 1 participant may experience both serious and nonserious event during study.
Gastrointestinal disorders Flatulence	0.49% 2/405 Safety data collected for all participants who received at least 1 dose of study drug(safety population).Same event may appear as AE and SAE.However,distinct events are presented.An event may categorized as serious in 1 participant and as nonserious in other participant,or 1 participant may experience both serious and nonserious event during study.
Gastrointestinal disorders Nausea	0.25% 1/405 Safety data collected for all participants who received at least 1 dose of study drug(safety population).Same event may appear as AE and SAE.However,distinct events are presented.An event may categorized as serious in 1 participant and as nonserious in other participant,or 1 participant may experience both serious and nonserious event during study.
Gastrointestinal disorders Oral pain	0.25% 1/405 Safety data collected for all participants who received at least 1 dose of study drug(safety population).Same event may appear as AE and SAE.However,distinct events are presented.An event may categorized as serious in 1 participant and as nonserious in other participant,or 1 participant may experience both serious and nonserious event during study.
Gastrointestinal disorders Paraesthesia oral	0.25% 1/405 Safety data collected for all participants who received at least 1 dose of study drug(safety population).Same event may appear as AE and SAE.However,distinct events are presented.An event may categorized as serious in 1 participant and as nonserious in other participant,or 1 participant may experience both serious and nonserious event during study.
Gastrointestinal disorders Toothache	6.4% 26/405 Safety data collected for all participants who received at least 1 dose of study drug(safety population).Same event may appear as AE and SAE.However,distinct events are presented.An event may categorized as serious in 1 participant and as nonserious in other participant,or 1 participant may experience both serious and nonserious event during study.
General disorders Chest pain	0.25% 1/405 Safety data collected for all participants who received at least 1 dose of study drug(safety population).Same event may appear as AE and SAE.However,distinct events are presented.An event may categorized as serious in 1 participant and as nonserious in other participant,or 1 participant may experience both serious and nonserious event during study.
General disorders Oedema peripheral	0.25% 1/405 Safety data collected for all participants who received at least 1 dose of study drug(safety population).Same event may appear as AE and SAE.However,distinct events are presented.An event may categorized as serious in 1 participant and as nonserious in other participant,or 1 participant may experience both serious and nonserious event during study.
General disorders Pain	0.49% 2/405 Safety data collected for all participants who received at least 1 dose of study drug(safety population).Same event may appear as AE and SAE.However,distinct events are presented.An event may categorized as serious in 1 participant and as nonserious in other participant,or 1 participant may experience both serious and nonserious event during study.
General disorders Pyrexia	0.25% 1/405 Safety data collected for all participants who received at least 1 dose of study drug(safety population).Same event may appear as AE and SAE.However,distinct events are presented.An event may categorized as serious in 1 participant and as nonserious in other participant,or 1 participant may experience both serious and nonserious event during study.
Infections and infestations Bronchitis	0.74% 3/405 Safety data collected for all participants who received at least 1 dose of study drug(safety population).Same event may appear as AE and SAE.However,distinct events are presented.An event may categorized as serious in 1 participant and as nonserious in other participant,or 1 participant may experience both serious and nonserious event during study.
Infections and infestations Diverticulitis	0.25% 1/405 Safety data collected for all participants who received at least 1 dose of study drug(safety population).Same event may appear as AE and SAE.However,distinct events are presented.An event may categorized as serious in 1 participant and as nonserious in other participant,or 1 participant may experience both serious and nonserious event during study.
Infections and infestations Ear infection	0.49% 2/405 Safety data collected for all participants who received at least 1 dose of study drug(safety population).Same event may appear as AE and SAE.However,distinct events are presented.An event may categorized as serious in 1 participant and as nonserious in other participant,or 1 participant may experience both serious and nonserious event during study.
Infections and infestations Gastroenteritis viral	0.25% 1/405 Safety data collected for all participants who received at least 1 dose of study drug(safety population).Same event may appear as AE and SAE.However,distinct events are presented.An event may categorized as serious in 1 participant and as nonserious in other participant,or 1 participant may experience both serious and nonserious event during study.
Infections and infestations Influenza	0.74% 3/405 Safety data collected for all participants who received at least 1 dose of study drug(safety population).Same event may appear as AE and SAE.However,distinct events are presented.An event may categorized as serious in 1 participant and as nonserious in other participant,or 1 participant may experience both serious and nonserious event during study.
Infections and infestations Localised infection	0.25% 1/405 Safety data collected for all participants who received at least 1 dose of study drug(safety population).Same event may appear as AE and SAE.However,distinct events are presented.An event may categorized as serious in 1 participant and as nonserious in other participant,or 1 participant may experience both serious and nonserious event during study.
Infections and infestations Nasopharyngitis	14.6% 59/405 Safety data collected for all participants who received at least 1 dose of study drug(safety population).Same event may appear as AE and SAE.However,distinct events are presented.An event may categorized as serious in 1 participant and as nonserious in other participant,or 1 participant may experience both serious and nonserious event during study.
Infections and infestations Pharyngitis streptococcal	0.74% 3/405 Safety data collected for all participants who received at least 1 dose of study drug(safety population).Same event may appear as AE and SAE.However,distinct events are presented.An event may categorized as serious in 1 participant and as nonserious in other participant,or 1 participant may experience both serious and nonserious event during study.
Infections and infestations Pneumonia	0.25% 1/405 Safety data collected for all participants who received at least 1 dose of study drug(safety population).Same event may appear as AE and SAE.However,distinct events are presented.An event may categorized as serious in 1 participant and as nonserious in other participant,or 1 participant may experience both serious and nonserious event during study.
Infections and infestations Sinusitis	1.5% 6/405 Safety data collected for all participants who received at least 1 dose of study drug(safety population).Same event may appear as AE and SAE.However,distinct events are presented.An event may categorized as serious in 1 participant and as nonserious in other participant,or 1 participant may experience both serious and nonserious event during study.
Infections and infestations Tonsillitis	0.25% 1/405 Safety data collected for all participants who received at least 1 dose of study drug(safety population).Same event may appear as AE and SAE.However,distinct events are presented.An event may categorized as serious in 1 participant and as nonserious in other participant,or 1 participant may experience both serious and nonserious event during study.
Infections and infestations Tooth abscess	0.74% 3/405 Safety data collected for all participants who received at least 1 dose of study drug(safety population).Same event may appear as AE and SAE.However,distinct events are presented.An event may categorized as serious in 1 participant and as nonserious in other participant,or 1 participant may experience both serious and nonserious event during study.
Infections and infestations Upper respiratory tract infection	0.49% 2/405 Safety data collected for all participants who received at least 1 dose of study drug(safety population).Same event may appear as AE and SAE.However,distinct events are presented.An event may categorized as serious in 1 participant and as nonserious in other participant,or 1 participant may experience both serious and nonserious event during study.
Injury, poisoning and procedural complications Animal bite	0.25% 1/405 Safety data collected for all participants who received at least 1 dose of study drug(safety population).Same event may appear as AE and SAE.However,distinct events are presented.An event may categorized as serious in 1 participant and as nonserious in other participant,or 1 participant may experience both serious and nonserious event during study.
Injury, poisoning and procedural complications Contusion	0.25% 1/405 Safety data collected for all participants who received at least 1 dose of study drug(safety population).Same event may appear as AE and SAE.However,distinct events are presented.An event may categorized as serious in 1 participant and as nonserious in other participant,or 1 participant may experience both serious and nonserious event during study.
Injury, poisoning and procedural complications Laceration	0.25% 1/405 Safety data collected for all participants who received at least 1 dose of study drug(safety population).Same event may appear as AE and SAE.However,distinct events are presented.An event may categorized as serious in 1 participant and as nonserious in other participant,or 1 participant may experience both serious and nonserious event during study.
Injury, poisoning and procedural complications Ligament sprain	1.5% 6/405 Safety data collected for all participants who received at least 1 dose of study drug(safety population).Same event may appear as AE and SAE.However,distinct events are presented.An event may categorized as serious in 1 participant and as nonserious in other participant,or 1 participant may experience both serious and nonserious event during study.
Injury, poisoning and procedural complications Limb injury	0.25% 1/405 Safety data collected for all participants who received at least 1 dose of study drug(safety population).Same event may appear as AE and SAE.However,distinct events are presented.An event may categorized as serious in 1 participant and as nonserious in other participant,or 1 participant may experience both serious and nonserious event during study.
Injury, poisoning and procedural complications Muscle strain	0.25% 1/405 Safety data collected for all participants who received at least 1 dose of study drug(safety population).Same event may appear as AE and SAE.However,distinct events are presented.An event may categorized as serious in 1 participant and as nonserious in other participant,or 1 participant may experience both serious and nonserious event during study.
Injury, poisoning and procedural complications Rib fracture	0.25% 1/405 Safety data collected for all participants who received at least 1 dose of study drug(safety population).Same event may appear as AE and SAE.However,distinct events are presented.An event may categorized as serious in 1 participant and as nonserious in other participant,or 1 participant may experience both serious and nonserious event during study.
Injury, poisoning and procedural complications Tibia fracture	0.25% 1/405 Safety data collected for all participants who received at least 1 dose of study drug(safety population).Same event may appear as AE and SAE.However,distinct events are presented.An event may categorized as serious in 1 participant and as nonserious in other participant,or 1 participant may experience both serious and nonserious event during study.
Musculoskeletal and connective tissue disorders Arthralgia	1.5% 6/405 Safety data collected for all participants who received at least 1 dose of study drug(safety population).Same event may appear as AE and SAE.However,distinct events are presented.An event may categorized as serious in 1 participant and as nonserious in other participant,or 1 participant may experience both serious and nonserious event during study.
Musculoskeletal and connective tissue disorders Back pain	3.7% 15/405 Safety data collected for all participants who received at least 1 dose of study drug(safety population).Same event may appear as AE and SAE.However,distinct events are presented.An event may categorized as serious in 1 participant and as nonserious in other participant,or 1 participant may experience both serious and nonserious event during study.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.25% 1/405 Safety data collected for all participants who received at least 1 dose of study drug(safety population).Same event may appear as AE and SAE.However,distinct events are presented.An event may categorized as serious in 1 participant and as nonserious in other participant,or 1 participant may experience both serious and nonserious event during study.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	1.2% 5/405 Safety data collected for all participants who received at least 1 dose of study drug(safety population).Same event may appear as AE and SAE.However,distinct events are presented.An event may categorized as serious in 1 participant and as nonserious in other participant,or 1 participant may experience both serious and nonserious event during study.
Musculoskeletal and connective tissue disorders Myalgia	3.0% 12/405 Safety data collected for all participants who received at least 1 dose of study drug(safety population).Same event may appear as AE and SAE.However,distinct events are presented.An event may categorized as serious in 1 participant and as nonserious in other participant,or 1 participant may experience both serious and nonserious event during study.
Musculoskeletal and connective tissue disorders Neck pain	0.25% 1/405 Safety data collected for all participants who received at least 1 dose of study drug(safety population).Same event may appear as AE and SAE.However,distinct events are presented.An event may categorized as serious in 1 participant and as nonserious in other participant,or 1 participant may experience both serious and nonserious event during study.
Musculoskeletal and connective tissue disorders Pain in extremity	0.74% 3/405 Safety data collected for all participants who received at least 1 dose of study drug(safety population).Same event may appear as AE and SAE.However,distinct events are presented.An event may categorized as serious in 1 participant and as nonserious in other participant,or 1 participant may experience both serious and nonserious event during study.
Musculoskeletal and connective tissue disorders Tendonitis	0.25% 1/405 Safety data collected for all participants who received at least 1 dose of study drug(safety population).Same event may appear as AE and SAE.However,distinct events are presented.An event may categorized as serious in 1 participant and as nonserious in other participant,or 1 participant may experience both serious and nonserious event during study.
Nervous system disorders Dizziness	1.2% 5/405 Safety data collected for all participants who received at least 1 dose of study drug(safety population).Same event may appear as AE and SAE.However,distinct events are presented.An event may categorized as serious in 1 participant and as nonserious in other participant,or 1 participant may experience both serious and nonserious event during study.
Nervous system disorders Dysgeusia	0.25% 1/405 Safety data collected for all participants who received at least 1 dose of study drug(safety population).Same event may appear as AE and SAE.However,distinct events are presented.An event may categorized as serious in 1 participant and as nonserious in other participant,or 1 participant may experience both serious and nonserious event during study.
Nervous system disorders Headache	2.5% 10/405 Safety data collected for all participants who received at least 1 dose of study drug(safety population).Same event may appear as AE and SAE.However,distinct events are presented.An event may categorized as serious in 1 participant and as nonserious in other participant,or 1 participant may experience both serious and nonserious event during study.
Nervous system disorders Hypoaesthesia	0.25% 1/405 Safety data collected for all participants who received at least 1 dose of study drug(safety population).Same event may appear as AE and SAE.However,distinct events are presented.An event may categorized as serious in 1 participant and as nonserious in other participant,or 1 participant may experience both serious and nonserious event during study.
Nervous system disorders Sinus headache	0.49% 2/405 Safety data collected for all participants who received at least 1 dose of study drug(safety population).Same event may appear as AE and SAE.However,distinct events are presented.An event may categorized as serious in 1 participant and as nonserious in other participant,or 1 participant may experience both serious and nonserious event during study.
Nervous system disorders Tension headache	1.5% 6/405 Safety data collected for all participants who received at least 1 dose of study drug(safety population).Same event may appear as AE and SAE.However,distinct events are presented.An event may categorized as serious in 1 participant and as nonserious in other participant,or 1 participant may experience both serious and nonserious event during study.
Renal and urinary disorders Renal pain	0.25% 1/405 Safety data collected for all participants who received at least 1 dose of study drug(safety population).Same event may appear as AE and SAE.However,distinct events are presented.An event may categorized as serious in 1 participant and as nonserious in other participant,or 1 participant may experience both serious and nonserious event during study.
Reproductive system and breast disorders Amenorrhoea	0.45% 1/223 Safety data collected for all participants who received at least 1 dose of study drug(safety population).Same event may appear as AE and SAE.However,distinct events are presented.An event may categorized as serious in 1 participant and as nonserious in other participant,or 1 participant may experience both serious and nonserious event during study.
Respiratory, thoracic and mediastinal disorders Cough	0.25% 1/405 Safety data collected for all participants who received at least 1 dose of study drug(safety population).Same event may appear as AE and SAE.However,distinct events are presented.An event may categorized as serious in 1 participant and as nonserious in other participant,or 1 participant may experience both serious and nonserious event during study.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.99% 4/405 Safety data collected for all participants who received at least 1 dose of study drug(safety population).Same event may appear as AE and SAE.However,distinct events are presented.An event may categorized as serious in 1 participant and as nonserious in other participant,or 1 participant may experience both serious and nonserious event during study.
Skin and subcutaneous tissue disorders Rosacea	0.25% 1/405 Safety data collected for all participants who received at least 1 dose of study drug(safety population).Same event may appear as AE and SAE.However,distinct events are presented.An event may categorized as serious in 1 participant and as nonserious in other participant,or 1 participant may experience both serious and nonserious event during study.
Vascular disorders Flushing	0.25% 1/405 Safety data collected for all participants who received at least 1 dose of study drug(safety population).Same event may appear as AE and SAE.However,distinct events are presented.An event may categorized as serious in 1 participant and as nonserious in other participant,or 1 participant may experience both serious and nonserious event during 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