Trial Outcomes & Findings for A Rollover Study For Subjects Discontinuing From UK-453,061 Studies For The Treatment Of HIV-1 (NCT NCT00824369)

NCT ID: NCT00824369

Last Updated: 2014-08-04

Results Overview

The numbers of participants with treatment emergent adverse events, serious adverse events or discontinuation due to adverse events was reported.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 52 participants
• Primary outcome timeframe: End of Study visit or the Early Termination visit
• Results posted on: 2014-08-04

Participant Flow

Participants from two parent studies (A5271015 and A5271022) were included if they discontinued treatment due to virologic failure or other reasons. Participants from 6 countries were enrolled into the A5271015 study and the A5271022 study enrolled participants from 8 countries.

Twelve and 40 participants who had received: LRV 500 mg QD, LRV 750 mg QD or efavirenz 600 mg QD (in A5271015);or LRV 750 mg QD, LRV 1000 mg QD or etravirine 200 mg BID (in A5271022) were enrolled and treated with open-label antiretrovirals excluding LRV. Data summaries were provided by the randomized treatment groups of the parent protocol.

Participant milestones

Measure	Participants From A5271015 - Lersivirine 500 mg Arm Participants who had received lersivirine 500 mg orally once daily in A5271015 parent study	Participants From A5271015 - Lersivirine 750 mg Arm Participants who had received lersivirine 750 mg orally once daily in A5271015 parent study	Participants From A5271015 - Efavirenz 600 mg Arm Participants who had received efavirenz 600 mg orally once daily in A5271015 parent study	Participants From A5271022 - Lersivirine 750 mg Arm Participants who had received lersivirine 750 mg orally once daily in A5271022 parent study	Participants From A5271022 - Lersivirine 1000 mg Arm Participants who had received lersivirine 1000 mg orally once daily in A5271022 parent study	Participants From A5271022 - Etravirine 200 mg Arm Participants who had received etravirine 200 mg twice daily in A5271022 parent study
Overall Study STARTED	5	4	3	11	12	17
Overall Study COMPLETED	4	4	2	9	11	16
Overall Study NOT COMPLETED	1	0	1	2	1	1

Reasons for withdrawal

Measure	Participants From A5271015 - Lersivirine 500 mg Arm Participants who had received lersivirine 500 mg orally once daily in A5271015 parent study	Participants From A5271015 - Lersivirine 750 mg Arm Participants who had received lersivirine 750 mg orally once daily in A5271015 parent study	Participants From A5271015 - Efavirenz 600 mg Arm Participants who had received efavirenz 600 mg orally once daily in A5271015 parent study	Participants From A5271022 - Lersivirine 750 mg Arm Participants who had received lersivirine 750 mg orally once daily in A5271022 parent study	Participants From A5271022 - Lersivirine 1000 mg Arm Participants who had received lersivirine 1000 mg orally once daily in A5271022 parent study	Participants From A5271022 - Etravirine 200 mg Arm Participants who had received etravirine 200 mg twice daily in A5271022 parent study
Overall Study Nolonger willing to participate in study	1	0	1	2	0	1
Overall Study Lost to Follow-up	0	0	0	0	1	0

Baseline Characteristics

A Rollover Study For Subjects Discontinuing From UK-453,061 Studies For The Treatment Of HIV-1

Baseline characteristics by cohort

Measure	Participants From A5271015 - Lersivirine 500 mg Arm n=5 Participants Participants who had received lersivirine 500 mg orally once daily in A5271015 parent study	Participants From A5271015 - Lersivirine 750 mg Arm n=4 Participants Participants who had received lersivirine 750 mg orally once daily in A5271015 parent study	Participants From A5271015 - Efavirenz 600 mg Arm n=3 Participants Participants who had received efavirenz 600 mg orally once daily in A5271015 parent study	Participants From A5271022 - Lersivirine 750 mg Arm n=11 Participants Participants who had received lersivirine 750 mg orally once daily in A5271022 parent study	Participants From A5271022 - Lersivirine 1000 mg Arm n=12 Participants Participants who had received lersivirine 1000 mg orally once daily in A5271022 parent study	Participants From A5271022 - Etravirine 200 mg Arm n=17 Participants Participants who had received etravirine 200 mg twice daily in A5271022 parent study	Total n=52 Participants Total of all reporting groups
Age, Customized Participants from A5271015	33.8 years STANDARD_DEVIATION 6.1 • n=5 Participants	31.5 years STANDARD_DEVIATION 1.7 • n=7 Participants	38.3 years STANDARD_DEVIATION 3.2 • n=5 Participants	NA years STANDARD_DEVIATION NA • n=4 Participants	NA years STANDARD_DEVIATION NA • n=21 Participants	NA years STANDARD_DEVIATION NA • n=10 Participants	34.2 years STANDARD_DEVIATION 4.8 • n=115 Participants
Age, Customized Participants from A5271022	NA years STANDARD_DEVIATION NA • n=5 Participants	NA years STANDARD_DEVIATION NA • n=7 Participants	NA years STANDARD_DEVIATION NA • n=5 Participants	42.7 years STANDARD_DEVIATION 9.1 • n=4 Participants	39.1 years STANDARD_DEVIATION 9.0 • n=21 Participants	41.6 years STANDARD_DEVIATION 9.4 • n=10 Participants	41.2 years STANDARD_DEVIATION 9.1 • n=115 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants	7 Participants n=21 Participants	11 Participants n=10 Participants	28 Participants n=115 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants	5 Participants n=21 Participants	6 Participants n=10 Participants	24 Participants n=115 Participants

PRIMARY outcome

Timeframe: End of Study visit or the Early Termination visit

Population: Safety population consisted of all participants who were enrolled in this study.

The numbers of participants with treatment emergent adverse events, serious adverse events or discontinuation due to adverse events was reported.

Outcome measures

Measure	Participants From A5271015 - Lersivirine 500 mg Arm n=5 Participants Participants who had received lersivirine 500 mg orally once daily in A5271015 parent study	Participants From A5271015 - Lersivirine 750 mg Arm n=4 Participants Participants who had received lersivirine 750 mg orally once daily in A5271015 parent study	Participants From A5271015 - Efavirenz 600 mg Arm n=3 Participants Participants who had received efavirenz 600 mg orally once daily in A5271015 parent study	Participants From A5271022 - Lersivirine 750 mg Arm n=11 Participants Participants who had received lersivirine 750 mg orally once daily in A5271022 parent study	Participants From A5271022 - Lersivirine 1000 mg Arm n=12 Participants Participants who had received lersivirine 1000 mg orally once daily in A5271022 parent study	Participants From A5271022 - Etravirine 200 mg Arm n=17 Participants Participants who had received etravirine 200 mg twice daily in A5271022 parent study
Number of Participants With Treatment-emergent Adverse Events, Serious Adverse Events and Participants Who Discontinued Due to Adverse Events Number of participants with adverse events	3 Number of participants	4 Number of participants	2 Number of participants	6 Number of participants	7 Number of participants	11 Number of participants
Number of Participants With Treatment-emergent Adverse Events, Serious Adverse Events and Participants Who Discontinued Due to Adverse Events Number of participants with serious adverse events	0 Number of participants	0 Number of participants	0 Number of participants	0 Number of participants	0 Number of participants	0 Number of participants
Number of Participants With Treatment-emergent Adverse Events, Serious Adverse Events and Participants Who Discontinued Due to Adverse Events Participants discontinued due to adverse events	0 Number of participants	0 Number of participants	0 Number of participants	0 Number of participants	0 Number of participants	0 Number of participants

SECONDARY outcome

Timeframe: Baseline, Month 6, Month 12 and Last visit

Population: Analysis population consisted of all participants who were enrolled. The lower limit of quantification of the HIV 1 RNA assays ranged from 20-70 copies/mL as they were performed by local labs. Participants where the HIV-RNA level was with a LLOQ \> 50 copies/mL were not included in the analysis at the visit of interest. Only available data was used.

Number of participants with HIV-1 RNA level <50 copies/mL plasma was noted at baseline, month 6, month 12 and last visit.

Outcome measures

Measure	Participants From A5271015 - Lersivirine 500 mg Arm n=5 Participants Participants who had received lersivirine 500 mg orally once daily in A5271015 parent study	Participants From A5271015 - Lersivirine 750 mg Arm n=4 Participants Participants who had received lersivirine 750 mg orally once daily in A5271015 parent study	Participants From A5271015 - Efavirenz 600 mg Arm n=3 Participants Participants who had received efavirenz 600 mg orally once daily in A5271015 parent study	Participants From A5271022 - Lersivirine 750 mg Arm n=11 Participants Participants who had received lersivirine 750 mg orally once daily in A5271022 parent study	Participants From A5271022 - Lersivirine 1000 mg Arm n=12 Participants Participants who had received lersivirine 1000 mg orally once daily in A5271022 parent study	Participants From A5271022 - Etravirine 200 mg Arm n=17 Participants Participants who had received etravirine 200 mg twice daily in A5271022 parent study
Number of Participants With Human Immunodeficiency Virus - 1 (HIV 1) Ribonucleic Acid (RNA) Level <50 Copies/mL at Baseline, Month 6, Month 12 and Last Visit Last Visit (N = 4, 3, 3, 11, 12, 17)	3 Number of participants	3 Number of participants	1 Number of participants	7 Number of participants	7 Number of participants	14 Number of participants
Number of Participants With Human Immunodeficiency Virus - 1 (HIV 1) Ribonucleic Acid (RNA) Level <50 Copies/mL at Baseline, Month 6, Month 12 and Last Visit Baseline (N = 5, 4, 3, 11, 12, 17)	2 Number of participants	3 Number of participants	0 Number of participants	9 Number of participants	7 Number of participants	15 Number of participants
Number of Participants With Human Immunodeficiency Virus - 1 (HIV 1) Ribonucleic Acid (RNA) Level <50 Copies/mL at Baseline, Month 6, Month 12 and Last Visit Month 6 (N = 3, 2, 3, 8, 11, 15)	2 Number of participants	2 Number of participants	2 Number of participants	5 Number of participants	5 Number of participants	12 Number of participants
Number of Participants With Human Immunodeficiency Virus - 1 (HIV 1) Ribonucleic Acid (RNA) Level <50 Copies/mL at Baseline, Month 6, Month 12 and Last Visit Month 12 (N = 3, 3, 1, 2, 5, 7)	2 Number of participants	3 Number of participants	0 Number of participants	2 Number of participants	4 Number of participants	5 Number of participants

SECONDARY outcome

Timeframe: Baseline, Month 6, Month 12 and Last visit

Population: Analysis population consisted of all participants who were enrolled in this study. Only available data were used.

Number of participants with HIV-1 RNA level <50 copies/mL plasma or below the lower limit of quantification (LLOQ) of the Assay were noted at Baseline, Month 6, Month 12 and Last visit. The lower limit of quantification (LLOQ) of the HIV 1 RNA assays ranged from 20 to 70 copies/mL as the assay was performed by local labs.

Outcome measures

Measure	Participants From A5271015 - Lersivirine 500 mg Arm n=5 Participants Participants who had received lersivirine 500 mg orally once daily in A5271015 parent study	Participants From A5271015 - Lersivirine 750 mg Arm n=4 Participants Participants who had received lersivirine 750 mg orally once daily in A5271015 parent study	Participants From A5271015 - Efavirenz 600 mg Arm n=3 Participants Participants who had received efavirenz 600 mg orally once daily in A5271015 parent study	Participants From A5271022 - Lersivirine 750 mg Arm n=11 Participants Participants who had received lersivirine 750 mg orally once daily in A5271022 parent study	Participants From A5271022 - Lersivirine 1000 mg Arm n=12 Participants Participants who had received lersivirine 1000 mg orally once daily in A5271022 parent study	Participants From A5271022 - Etravirine 200 mg Arm n=17 Participants Participants who had received etravirine 200 mg twice daily in A5271022 parent study
Number of Participants With HIV 1 RNA Level <50 Copies/mL or Below the Lower Limit of Quantification (LLOQ) of the Assay at Baseline, Month 6, Month 12 and Last Visit Baseline (N = 5, 4, 3, 11, 12, 17)	2 Number of participants	3 Number of participants	0 Number of participants	9 Number of participants	7 Number of participants	15 Number of participants
Number of Participants With HIV 1 RNA Level <50 Copies/mL or Below the Lower Limit of Quantification (LLOQ) of the Assay at Baseline, Month 6, Month 12 and Last Visit Month 6 (N = 4, 4, 3, 8, 11, 15)	3 Number of participants	4 Number of participants	2 Number of participants	5 Number of participants	5 Number of participants	12 Number of participants
Number of Participants With HIV 1 RNA Level <50 Copies/mL or Below the Lower Limit of Quantification (LLOQ) of the Assay at Baseline, Month 6, Month 12 and Last Visit Month 12 (N = 4, 4, 1, 2, 5, 7)	3 Number of participants	4 Number of participants	0 Number of participants	2 Number of participants	4 Number of participants	5 Number of participants
Number of Participants With HIV 1 RNA Level <50 Copies/mL or Below the Lower Limit of Quantification (LLOQ) of the Assay at Baseline, Month 6, Month 12 and Last Visit Last Visit (N = 5, 4, 3, 11, 12, 17)	4 Number of participants	4 Number of participants	1 Number of participants	7 Number of participants	7 Number of participants	14 Number of participants

SECONDARY outcome

Timeframe: Baseline, Month 6 and Month 12

Population: Analysis population consisted of all participants who were enrolled in this study. Only available data were used.

Participant's immunological status assessed by CD4+ lymphocyte count.

Outcome measures

Measure	Participants From A5271015 - Lersivirine 500 mg Arm n=5 Participants Participants who had received lersivirine 500 mg orally once daily in A5271015 parent study	Participants From A5271015 - Lersivirine 750 mg Arm n=4 Participants Participants who had received lersivirine 750 mg orally once daily in A5271015 parent study	Participants From A5271015 - Efavirenz 600 mg Arm n=3 Participants Participants who had received efavirenz 600 mg orally once daily in A5271015 parent study	Participants From A5271022 - Lersivirine 750 mg Arm n=11 Participants Participants who had received lersivirine 750 mg orally once daily in A5271022 parent study	Participants From A5271022 - Lersivirine 1000 mg Arm n=12 Participants Participants who had received lersivirine 1000 mg orally once daily in A5271022 parent study	Participants From A5271022 - Etravirine 200 mg Arm n=17 Participants Participants who had received etravirine 200 mg twice daily in A5271022 parent study
Absolute Cluster of Differentiation 4+ (CD4+) Cell Count (Cells/uL) at Baseline, Month 6 and Month 12 Month 6 (N = 4, 4, 2, 8, 11, 15)	456 cells/uL Standard Deviation 175	514 cells/uL Standard Deviation 195	606 cells/uL Standard Deviation 120	615 cells/uL Standard Deviation 248	413 cells/uL Standard Deviation 266	451 cells/uL Standard Deviation 221
Absolute Cluster of Differentiation 4+ (CD4+) Cell Count (Cells/uL) at Baseline, Month 6 and Month 12 Month 12 (N = 4, 4, 2, 3, 6, 7)	618 cells/uL Standard Deviation 285	607 cells/uL Standard Deviation 326	556 cells/uL Standard Deviation 65	378 cells/uL Standard Deviation 57	361 cells/uL Standard Deviation 309	452 cells/uL Standard Deviation 247
Absolute Cluster of Differentiation 4+ (CD4+) Cell Count (Cells/uL) at Baseline, Month 6 and Month 12 Baseline (N = 4, 4, 3, 11, 12, 17)	285 cells/uL Standard Deviation 97	574 cells/uL Standard Deviation 274	564 cells/uL Standard Deviation 121	473 cells/uL Standard Deviation 191	411 cells/uL Standard Deviation 259	455 cells/uL Standard Deviation 212

SECONDARY outcome

Timeframe: Baseline, Month 6 and Month 12

Population: Analysis population consisted of all participants who were enrolled in this study. Only available data were used.

Participant's immunological status assessed by CD4+ lymphocyte count.

Outcome measures

Measure	Participants From A5271015 - Lersivirine 500 mg Arm n=5 Participants Participants who had received lersivirine 500 mg orally once daily in A5271015 parent study	Participants From A5271015 - Lersivirine 750 mg Arm n=4 Participants Participants who had received lersivirine 750 mg orally once daily in A5271015 parent study	Participants From A5271015 - Efavirenz 600 mg Arm n=3 Participants Participants who had received efavirenz 600 mg orally once daily in A5271015 parent study	Participants From A5271022 - Lersivirine 750 mg Arm n=11 Participants Participants who had received lersivirine 750 mg orally once daily in A5271022 parent study	Participants From A5271022 - Lersivirine 1000 mg Arm n=12 Participants Participants who had received lersivirine 1000 mg orally once daily in A5271022 parent study	Participants From A5271022 - Etravirine 200 mg Arm n=17 Participants Participants who had received etravirine 200 mg twice daily in A5271022 parent study
CD4+ Cell Count (Percentage) at Baseline, Month 6 and Month 12 Baseline (N = 4, 4, 3, 11, 12, 17)	21 Percentage of total lymphocytes Standard Deviation 10	29 Percentage of total lymphocytes Standard Deviation 9	26 Percentage of total lymphocytes Standard Deviation 2	26 Percentage of total lymphocytes Standard Deviation 10	21 Percentage of total lymphocytes Standard Deviation 12	23 Percentage of total lymphocytes Standard Deviation 8
CD4+ Cell Count (Percentage) at Baseline, Month 6 and Month 12 Month 12 (N = 4, 4, 3, 3, 6, 6)	38 Percentage of total lymphocytes Standard Deviation 14	30 Percentage of total lymphocytes Standard Deviation 10	27 Percentage of total lymphocytes Standard Deviation 7	26 Percentage of total lymphocytes Standard Deviation 11	19 Percentage of total lymphocytes Standard Deviation 10	18 Percentage of total lymphocytes Standard Deviation 7
CD4+ Cell Count (Percentage) at Baseline, Month 6 and Month 12 Month 6 (N = 4, 4, 3, 8, 11, 14)	36 Percentage of total lymphocytes Standard Deviation 14	31 Percentage of total lymphocytes Standard Deviation 12	26 Percentage of total lymphocytes Standard Deviation 1	28 Percentage of total lymphocytes Standard Deviation 12	22 Percentage of total lymphocytes Standard Deviation 11	23 Percentage of total lymphocytes Standard Deviation 6

Adverse Events

Participants From A5271015 - Lersivirine 500 mg Arm

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Participants From A5271015 - Lersivirine 750 mg Arm

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Participants From A5271015 - Efavirenz 600 mg Arm

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Participants From A5271022 - Lersivirine 750 mg Arm

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Participants From A5271022 - Lersivirine 1000 mg Arm

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Participants From A5271022 - Etravirine 200 mg Arm

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Participants From A5271015 - Lersivirine 500 mg Arm n=5 participants at risk Participants who had received lersivirine 500 mg orally once daily in A5271015 parent study	Participants From A5271015 - Lersivirine 750 mg Arm n=4 participants at risk Participants who had received lersivirine 750 mg orally once daily in A5271015 parent study	Participants From A5271015 - Efavirenz 600 mg Arm n=3 participants at risk Participants who had received efavirenz 600 mg orally once daily in A5271015 parent study	Participants From A5271022 - Lersivirine 750 mg Arm n=11 participants at risk Participants who had received lersivirine 750 mg orally once daily in A5271022 parent study	Participants From A5271022 - Lersivirine 1000 mg Arm n=12 participants at risk Participants who had received lersivirine 1000 mg orally once daily in A5271022 parent study	Participants From A5271022 - Etravirine 200 mg Arm n=17 participants at risk Participants who had received etravirine 200 mg twice daily in A5271022 parent study
Gastrointestinal disorders Abdominal pain lower	20.0% 1/5 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	75.0% 3/4 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	66.7% 2/3 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/11 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/12 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/17 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.
Gastrointestinal disorders Anal haemorrhage	0.00% 0/5 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	25.0% 1/4 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/3 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/11 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/12 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/17 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.
Gastrointestinal disorders Aphthous stomatitis	0.00% 0/5 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/4 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	33.3% 1/3 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/11 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/12 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/17 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.
Gastrointestinal disorders Diarrhoea	20.0% 1/5 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	50.0% 2/4 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	33.3% 1/3 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/11 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/12 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/17 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.
Gastrointestinal disorders Haemorrhoids	0.00% 0/5 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	25.0% 1/4 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/3 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/11 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/12 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/17 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.
General disorders Fatigue	0.00% 0/5 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	25.0% 1/4 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/3 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/11 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/12 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/17 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.
Hepatobiliary disorders Jaundice	0.00% 0/5 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/4 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	33.3% 1/3 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/11 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/12 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/17 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.
Infections and infestations Nasopharyngitis	0.00% 0/5 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	25.0% 1/4 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/3 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/11 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/12 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/17 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.
Infections and infestations Oral herpes	0.00% 0/5 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	25.0% 1/4 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/3 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/11 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/12 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/17 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.
Infections and infestations Varicella	0.00% 0/5 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	25.0% 1/4 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/3 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/11 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/12 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/17 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.
Injury, poisoning and procedural complications Ligament sprain	20.0% 1/5 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/4 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/3 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/11 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/12 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/17 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.
Investigations Blood creatinine increased	0.00% 0/5 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/4 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	33.3% 1/3 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/11 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/12 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/17 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/5 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	25.0% 1/4 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/3 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/11 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/12 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	5.9% 1/17 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.
Nervous system disorders Carpal tunnel syndrome	0.00% 0/5 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	25.0% 1/4 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/3 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/11 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/12 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/17 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.
Psychiatric disorders Anxiety	20.0% 1/5 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/4 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/3 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/11 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/12 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/17 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.
Psychiatric disorders Stress	20.0% 1/5 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/4 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/3 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/11 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/12 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/17 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.
Reproductive system and breast disorders Epididymitis	20.0% 1/5 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/4 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/3 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/11 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/12 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/17 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.
Reproductive system and breast disorders Vaginal discharge	20.0% 1/5 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/4 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/3 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/11 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/12 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/17 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.
Respiratory, thoracic and mediastinal disorders Cough	20.0% 1/5 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/4 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/3 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/11 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/12 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/17 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/5 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/4 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	33.3% 1/3 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/11 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/12 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/17 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/5 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/4 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	33.3% 1/3 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/11 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/12 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	5.9% 1/17 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.
Blood and lymphatic system disorders Anaemia	0.00% 0/5 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/4 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/3 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/11 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/12 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	5.9% 1/17 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/5 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/4 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/3 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/11 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	8.3% 1/12 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/17 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.
Eye disorders Conjunctivitis	0.00% 0/5 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/4 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/3 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/11 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/12 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	5.9% 1/17 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/5 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/4 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/3 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/11 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/12 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	5.9% 1/17 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.
Gastrointestinal disorders Cheilitis	0.00% 0/5 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/4 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/3 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/11 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	8.3% 1/12 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/17 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.
Gastrointestinal disorders Constipation	0.00% 0/5 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/4 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/3 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	9.1% 1/11 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/12 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/17 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.
Gastrointestinal disorders Frequent bowel movements	0.00% 0/5 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/4 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/3 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/11 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	8.3% 1/12 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/17 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/5 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/4 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/3 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/11 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	8.3% 1/12 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/17 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.
Gastrointestinal disorders Nausea	0.00% 0/5 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/4 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/3 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	9.1% 1/11 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/12 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/17 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.
General disorders Chest pain	0.00% 0/5 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/4 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/3 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/11 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	8.3% 1/12 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/17 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.
General disorders Cyst	0.00% 0/5 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/4 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/3 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/11 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/12 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	5.9% 1/17 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.
Hepatobiliary disorders Hepatomegaly	0.00% 0/5 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/4 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/3 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/11 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/12 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	5.9% 1/17 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.
Immune system disorders Seasonal allergy	0.00% 0/5 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/4 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/3 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/11 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	8.3% 1/12 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/17 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.
Infections and infestations Acarodermatitis	0.00% 0/5 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/4 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/3 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	9.1% 1/11 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/12 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/17 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.
Infections and infestations Cellulitis	0.00% 0/5 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/4 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/3 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/11 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/12 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	5.9% 1/17 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.
Infections and infestations Herpes zoster	0.00% 0/5 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/4 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/3 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/11 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	8.3% 1/12 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/17 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.
Infections and infestations Onychomycosis	0.00% 0/5 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/4 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/3 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/11 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/12 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	5.9% 1/17 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.
Infections and infestations Oropharyngeal candidiasis	0.00% 0/5 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/4 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/3 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/11 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	8.3% 1/12 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/17 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.
Infections and infestations Salpingo-oophoritis	0.00% 0/5 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/4 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/3 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	9.1% 1/11 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/12 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/17 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.
Infections and infestations Upper respiratory tract infection	0.00% 0/5 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/4 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/3 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	9.1% 1/11 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/12 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	5.9% 1/17 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.
Investigations Blood glucose increased	0.00% 0/5 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/4 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/3 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	9.1% 1/11 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/12 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	5.9% 1/17 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.
Investigations Blood pressure increased	0.00% 0/5 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/4 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/3 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/11 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/12 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	5.9% 1/17 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.
Investigations Blood thyroid stimulating hormone increased	0.00% 0/5 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/4 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/3 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	9.1% 1/11 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/12 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/17 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.
Investigations Blood triglycerides increased	0.00% 0/5 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/4 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/3 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/11 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/12 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	5.9% 1/17 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.
Investigations Gamma-glutamyltransferase increased	0.00% 0/5 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/4 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/3 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/11 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/12 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	5.9% 1/17 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.
Investigations Low density lipoprotein increased	0.00% 0/5 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/4 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/3 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/11 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/12 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	5.9% 1/17 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.
Investigations Weight decreased	0.00% 0/5 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/4 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/3 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/11 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/12 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	5.9% 1/17 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/5 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/4 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/3 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/11 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	16.7% 2/12 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/17 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.
Metabolism and nutrition disorders Dyslipidaemia	0.00% 0/5 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/4 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/3 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	9.1% 1/11 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/12 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	11.8% 2/17 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/5 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/4 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/3 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/11 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	8.3% 1/12 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/17 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/5 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/4 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/3 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/11 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/12 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	5.9% 1/17 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/5 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/4 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/3 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/11 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	8.3% 1/12 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/17 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/5 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/4 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/3 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/11 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	8.3% 1/12 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/17 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.
Nervous system disorders Dizziness	0.00% 0/5 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/4 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/3 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/11 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/12 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	5.9% 1/17 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.
Nervous system disorders Nerve compression	0.00% 0/5 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/4 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/3 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/11 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	8.3% 1/12 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/17 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.
Nervous system disorders Somnolence	0.00% 0/5 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/4 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/3 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/11 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	8.3% 1/12 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	5.9% 1/17 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.
Psychiatric disorders Depression	0.00% 0/5 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/4 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/3 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/11 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	8.3% 1/12 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/17 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.
Renal and urinary disorders Renal impairment	0.00% 0/5 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/4 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/3 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/11 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/12 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	5.9% 1/17 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.
Reproductive system and breast disorders Breast mass	0.00% 0/5 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/4 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/3 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/11 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/12 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	5.9% 1/17 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.
Skin and subcutaneous tissue disorders Lichen planus	0.00% 0/5 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/4 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/3 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/11 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/12 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	5.9% 1/17 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/5 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/4 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/3 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/11 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	8.3% 1/12 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/17 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.
Vascular disorders Hypertension	0.00% 0/5 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/4 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/3 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	9.1% 1/11 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	8.3% 1/12 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.	0.00% 0/17 • End of Study visit or the Early Termination visit There were no serious adverse events experienced by the subjects in this study.

Additional Information

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Results disclosure agreements

• Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
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Restriction type: OTHER