Trial Outcomes & Findings for A Long Term Safety Study Of Lersivirine For The Treatment Of HIV-1 Infection In Subjects Who Have Completed Treatment With Lersivirine In Studies A5271015 And A5271022 (NCT NCT01254656)

Last Updated: 2014-06-09

Results Overview

Number of participants with HIV-1 RNA level \<50 copies/mL plasma was summarized at 48 weeks i.e. 144 weeks from Day 1 of the parent protocol. Roche Amplicor HIV-1 Monitor assay was used to measure the HIV-1 RNA level.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

108 participants

Primary outcome timeframe

144 Weeks from Day 1 of the parent protocol

Results posted on

2014-06-09

Participant Flow

Participants who had completed 96 weeks of treatment with lersivirine in the A5271015 parent study were enrolled in this extension study. One participant from a second parent study (A5271022) was initially enrolled in Study A5271037, but later discontinued from A5271037.

Participants were required to have plasma HIV-1 ribonucleic acid (RNA) \<50 copies/mL at Week 84 of the parent protocol. Of 108 participants screened in the parent protocol A5271015, 47, 43, and 18 participants from the lersivirine 500 mg, lersivirine 750 mg, and efavirenz 600 mg groups, respectively, were enrolled in Study A5271037.

Participant milestones

Participant milestones
Measure	Lersivirine (LRV) 500 mg Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD	LRV 750 mg Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD	Efavirenz (EFV) 600 mg Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
Overall Study STARTED	47	43	18
Overall Study Treated	47	43	18
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	47	43	18

Reasons for withdrawal

Reasons for withdrawal
Measure	Lersivirine (LRV) 500 mg Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD	LRV 750 mg Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD	Efavirenz (EFV) 600 mg Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
Overall Study Discontinued due to termination of study	40	39	13
Overall Study Lack of Efficacy	3	0	0
Overall Study Lost to Follow-up	1	0	2
Overall Study Withdrawal by Subject	2	2	1
Overall Study Pregnancy	0	0	2
Overall Study Adverse Event	1	1	0
Overall Study Death	0	1	0

Baseline Characteristics

A Long Term Safety Study Of Lersivirine For The Treatment Of HIV-1 Infection In Subjects Who Have Completed Treatment With Lersivirine In Studies A5271015 And A5271022

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lersivirine (LRV) 500 mg n=47 Participants Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD	LRV 750 mg n=43 Participants Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD	Efavirenz (EFV) 600 mg n=18 Participants Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD	Total n=108 Participants Total of all reporting groups
Age, Continuous	36.6 Years STANDARD_DEVIATION 8.4 • n=5 Participants	35.8 Years STANDARD_DEVIATION 8.7 • n=7 Participants	38.5 Years STANDARD_DEVIATION 7.8 • n=5 Participants	36.6 Years STANDARD_DEVIATION 8.4 • n=4 Participants
Age, Customized < 18 Years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Customized 18 - 44 Years	41 Participants n=5 Participants	37 Participants n=7 Participants	14 Participants n=5 Participants	92 Participants n=4 Participants
Age, Customized 45 - 64 Years	6 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	16 Participants n=4 Participants
Age, Customized >= 65 Years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	11 Participants n=7 Participants	8 Participants n=5 Participants	29 Participants n=4 Participants
Sex: Female, Male Male	37 Participants n=5 Participants	32 Participants n=7 Participants	10 Participants n=5 Participants	79 Participants n=4 Participants

PRIMARY outcome

Timeframe: 144 Weeks from Day 1 of the parent protocol

Population: All participants enrolled in this protocol constituted the analysis population associated with each of the parent protocols and all available data were used for efficacy analyses.

Outcome measures

Outcome measures
Measure	LRV 750 mg n=43 Participants Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD	Efavirenz (EFV) 600 mg n=18 Participants Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD	Lersivirine (LRV) 500 mg n=47 Participants Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
Number of Participants With Plasma Human Immunodeficiency Virus - 1 (HIV-1) Ribonucleic Acid (RNA) Level <50 Copies/mL at 144 Weeks From Day 1 of the Parent Protocol	40 Participants	16 Participants	40 Participants

SECONDARY outcome

Timeframe: Up to Week 208

Population: Analyses included all enrolled participants. Last visit used the last available visit of each participant. Discontinued from study, lost to follow-up, or missing HIV-1 RNA level data at last visit were considered to have HIV-1 RNA levels \>=50 copies/mL. Participants discontinued due to program termination were not considered as discontinuations.

Number of participants with HIV-1 RNA level \<50 copies/mL plasma was summarized at last visit. Abbott RealTime HIV-1 assay was used to measure the HIV-1 RNA level.

Outcome measures

Outcome measures
Measure	LRV 750 mg n=43 Participants Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD	Efavirenz (EFV) 600 mg n=18 Participants Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD	Lersivirine (LRV) 500 mg n=47 Participants Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
Number of Participants With Plasma HIV-1 RNA Level <50 Copies/mL up to Week 208	38 Participants	13 Participants	39 Participants

SECONDARY outcome

Timeframe: 144 Weeks from Day 1 of the parent protocol

Population: All participants enrolled in this protocol constituted the analysis population associated with each of the parent protocols and all available data were used for efficacy analyses. Last observation carried forward (LOCF) was used to impute missing values.

Participant's immunological status assessed by CD4+ lymphocyte count (absolute and percentage) at 48 weeks (ie, 144 weeks from Day 1 of the parent protocol)

Outcome measures

Outcome measures
Measure	LRV 750 mg n=43 Participants Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD	Efavirenz (EFV) 600 mg n=18 Participants Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD	Lersivirine (LRV) 500 mg n=47 Participants Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
Change From Baseline in CD4+ Lymphocyte Counts (Absolute) at 144 Weeks From Day 1 of the Parent Protocol	302 cells/uL Standard Deviation 163	303 cells/uL Standard Deviation 163	293 cells/uL Standard Deviation 206

SECONDARY outcome

Timeframe: 144 Weeks from Day 1 of the parent protocol

Participant's immunological status assessed by CD4+ lymphocyte count (absolute and percentage) at 48 weeks (ie, 144 weeks from Day 1 of the parent protocol)

Outcome measures

Outcome measures
Measure	LRV 750 mg n=43 Participants Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD	Efavirenz (EFV) 600 mg n=18 Participants Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD	Lersivirine (LRV) 500 mg n=47 Participants Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
Change From Baseline in CD4+ Lymphocyte Counts (Percentage) at 144 Weeks From Day 1 of the Parent Protocol	13 Percentage Standard Deviation 5	13 Percentage Standard Deviation 6	13 Percentage Standard Deviation 6

SECONDARY outcome

Timeframe: 192 Weeks from Day 1 of the parent protocol

Population: Analyses included all enrolled participants. Week 192 data are presented, as Week 208 had few participants. For participants who discontinued prematurely, LOCF was used to impute values for post discontinuation visits. Participants who discontinued due to termination of the program were not included in the analysis for the post termination visits.

Participant's immunological status assessed by CD4+ lymphocyte count (absolute and percentage) at 192 weeks from Day 1 of the parent protocol.

Outcome measures

Outcome measures
Measure	LRV 750 mg n=34 Participants Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD	Efavirenz (EFV) 600 mg n=18 Participants Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD	Lersivirine (LRV) 500 mg n=38 Participants Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
Change From Baseline in CD4+ Lymphocyte Counts (Absolute) at 192 Weeks From Day 1 of the Parent Protocol	304 cells/uL Standard Deviation 159	300 cells/uL Standard Deviation 220	308 cells/uL Standard Deviation 191

SECONDARY outcome

Timeframe: 192 Weeks from Day 1 of the parent protocol

Population: Analyses included all enrolled participants. Week 192 data are presented as Week 208 had few participants. For participants who discontinued prematurely, LOCF was used to impute values for post discontinuation visits. Participants who discontinued due to termination of the program were not included in the analysis for the post termination visits.

Participant's immunological status assessed by CD4+ lymphocyte count (absolute and percentage) at 192 weeks from Day 1 of the parent protocol.

Outcome measures

Outcome measures
Measure	LRV 750 mg n=34 Participants Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD	Efavirenz (EFV) 600 mg n=18 Participants Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD	Lersivirine (LRV) 500 mg n=38 Participants Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
Change From Baseline in CD4+ Lymphocyte Counts (Percentage) at 192 Weeks From Day 1 of the Parent Protocol	15 Percentage Standard Deviation 6	12 Percentage Standard Deviation 6	13 Percentage Standard Deviation 6

SECONDARY outcome

Timeframe: Week 96 through study termination

Population: The virology analysis set included only evaluable participants i.e. those having samples with valid genotypic or phenotypic susceptibility testing results and HIV-1 RNA \>500 copies/mL. However, samples with observed emergence of resistance-associated mutations and HIV-1 RNA level ≤500 copies/mL or missing HIV-1 RNA level, were also noted.

Virology analysis included virus susceptibility (phenotype and genotype)to a standard panel of approved antiretrovirals as determined by the Monogram Biosciences PhenoSense GT assay. Below analysis table included the following parameters: 1. "protocol-defined treatment failure" was defined as an increase in HIV-1 RNA to detectable levels (≥50 copies/mL) on 2 consecutive measurements, the second measurement taken no more than 14 days after the first measurement); 2. "Treatment failure": treatment failure (both virologic and non-virologic) was defined as a subject who met the protocol-defined treatment failure criterion or discontinued from the study; 3. "NRTI or NNRTI resistance mutations": nucleoside reverse transcriptase inhibitor or lersivirine-associated resistance-associated mutations (RAM) based on the International AIDS Society-USA (IAS-USA) RAM guidelines; 4. 'with result' meant an analyzed sample returned genotypic result or phenotypic result or both.

Outcome measures

Outcome measures
Measure	LRV 750 mg n=43 Participants Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD	Efavirenz (EFV) 600 mg n=18 Participants Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD	Lersivirine (LRV) 500 mg n=47 Participants Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
Virology Analysis Participant Accountability From Week 96 Through Study Termination Treatment failure (TF)	5 Participants	5 Participants	8 Participants
Virology Analysis Participant Accountability From Week 96 Through Study Termination Protocol defined treatment failure	3 Participants	0 Participants	4 Participants
Virology Analysis Participant Accountability From Week 96 Through Study Termination TF analysed - HIV-1 RNA >500 c/mL	0 Participants	0 Participants	1 Participants
Virology Analysis Participant Accountability From Week 96 Through Study Termination TF analysed - HIV-1 RNA >500 c/mL with result	0 Participants	0 Participants	1 Participants
Virology Analysis Participant Accountability From Week 96 Through Study Termination TF analysed - HIV-1 RNA <= 500 c/mL	2 Participants	2 Participants	5 Participants
Virology Analysis Participant Accountability From Week 96 Through Study Termination TF analysed - HIV-1 RNA <= 500 c/mL with result	1 Participants	0 Participants	2 Participants
Virology Analysis Participant Accountability From Week 96 Through Study Termination NRTI or NNRTI resistance mutations	0 Participants	0 Participants	0 Participants

Adverse Events

Lersivirine (LRV) 500 mg

Serious events: 6 serious events

Other events: 30 other events

Deaths: 0 deaths

LRV 750 mg

Serious events: 5 serious events

Other events: 35 other events

Deaths: 0 deaths

Efavirenz (EFV) 600 mg

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

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

Serious adverse events
Measure	Lersivirine (LRV) 500 mg n=47 participants at risk Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD	LRV 750 mg n=43 participants at risk Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD	Efavirenz (EFV) 600 mg n=18 participants at risk Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/47 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	2.3% 1/43 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/18 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.
Gastrointestinal disorders Large intestine perforation	0.00% 0/47 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	2.3% 1/43 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/18 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.
Hepatobiliary disorders Biliary colic	2.1% 1/47 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/43 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/18 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.
Hepatobiliary disorders Cholelithiasis	2.1% 1/47 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/43 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/18 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.
Hepatobiliary disorders Hepatitis	2.1% 1/47 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/43 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/18 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.
Infections and infestations Chronic sinusitis	2.1% 1/47 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/43 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/18 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.
Infections and infestations Gastroenteritis	2.1% 1/47 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/43 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/18 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.
Infections and infestations Hepatitis C	2.1% 1/47 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/43 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/18 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.
Infections and infestations Syphilis	2.1% 1/47 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/43 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/18 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.
Injury, poisoning and procedural complications Chest injury	0.00% 0/47 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	2.3% 1/43 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/18 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/47 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	2.3% 1/43 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/18 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.
Injury, poisoning and procedural complications Wound	0.00% 0/47 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	2.3% 1/43 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/18 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.
Investigations Blood creatine phosphokinase increased	0.00% 0/47 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	2.3% 1/43 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/18 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.
Investigations Blood lactate dehydrogenase increased	0.00% 0/47 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	2.3% 1/43 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/18 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma	0.00% 0/47 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	2.3% 1/43 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/18 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal carcinoma	0.00% 0/47 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	2.3% 1/43 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/18 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian adenoma	0.00% 0/47 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	2.3% 1/43 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/18 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Vaginal cancer	0.00% 0/47 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	2.3% 1/43 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/18 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.
Psychiatric disorders Paranoia	2.1% 1/47 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/43 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/18 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.

Other adverse events
Measure	Lersivirine (LRV) 500 mg n=47 participants at risk Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD	LRV 750 mg n=43 participants at risk Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD	Efavirenz (EFV) 600 mg n=18 participants at risk Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
Infections and infestations Oropharyngeal gonococcal infection	0.00% 0/47 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	2.3% 1/43 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/18 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.
Infections and infestations Paronychia	0.00% 0/47 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	2.3% 1/43 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/18 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.
Renal and urinary disorders Renal cyst	2.1% 1/47 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/43 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/18 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.
Blood and lymphatic system disorders Eosinophilia	2.1% 1/47 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/43 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/18 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.
Blood and lymphatic system disorders Lymphadenitis	0.00% 0/47 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/43 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	5.6% 1/18 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.
Blood and lymphatic system disorders Lymphadenopathy	2.1% 1/47 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/43 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/18 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.
Cardiac disorders Bradycardia	2.1% 1/47 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/43 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/18 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.
Cardiac disorders Myocardial ischaemia	2.1% 1/47 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/43 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/18 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.
Ear and labyrinth disorders Cerumen impaction	2.1% 1/47 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	2.3% 1/43 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/18 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.
Ear and labyrinth disorders Tinnitus	0.00% 0/47 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	2.3% 1/43 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/18 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.
Eye disorders Chalazion	0.00% 0/47 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	2.3% 1/43 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/18 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.
Eye disorders Conjunctivitis	0.00% 0/47 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	2.3% 1/43 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/18 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.
Eye disorders Conjunctivitis allergic	0.00% 0/47 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	2.3% 1/43 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/18 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.
Eye disorders Ocular toxicity	2.1% 1/47 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/43 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/18 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.
Gastrointestinal disorders Abdominal pain	0.00% 0/47 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	4.7% 2/43 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/18 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/47 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	2.3% 1/43 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/18 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.
Gastrointestinal disorders Abdominal tenderness	0.00% 0/47 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	2.3% 1/43 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/18 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.
Gastrointestinal disorders Anal fissure	0.00% 0/47 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	2.3% 1/43 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/18 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.
Gastrointestinal disorders Anogenital dysplasia	2.1% 1/47 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/43 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/18 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.
Gastrointestinal disorders Aphthous stomatitis	0.00% 0/47 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	2.3% 1/43 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/18 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.
Gastrointestinal disorders Colitis	0.00% 0/47 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	2.3% 1/43 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/18 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.
Gastrointestinal disorders Constipation	0.00% 0/47 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	2.3% 1/43 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/18 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.
Gastrointestinal disorders Diarrhoea	0.00% 0/47 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	7.0% 3/43 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/18 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.
Gastrointestinal disorders Diverticulum	2.1% 1/47 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/43 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/18 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.
Gastrointestinal disorders Dyspepsia	2.1% 1/47 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	7.0% 3/43 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/18 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.
Gastrointestinal disorders Dysphagia	0.00% 0/47 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	2.3% 1/43 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/18 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.
Gastrointestinal disorders Gastritis	0.00% 0/47 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	4.7% 2/43 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	5.6% 1/18 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.
Gastrointestinal disorders Nausea	0.00% 0/47 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	4.7% 2/43 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/18 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.
Gastrointestinal disorders Palatal disorder	2.1% 1/47 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/43 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/18 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.
Gastrointestinal disorders Proctalgia	0.00% 0/47 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	2.3% 1/43 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/18 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.
Gastrointestinal disorders Proctitis ulcerative	2.1% 1/47 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/43 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/18 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.
Gastrointestinal disorders Rectal haemorrhage	2.1% 1/47 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/43 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/18 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.
Gastrointestinal disorders Toothache	0.00% 0/47 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	2.3% 1/43 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/18 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.
Gastrointestinal disorders Vomiting	2.1% 1/47 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/43 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	5.6% 1/18 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.
General disorders Asthenia	0.00% 0/47 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	2.3% 1/43 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/18 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.
General disorders Chest pain	2.1% 1/47 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	7.0% 3/43 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/18 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.
General disorders Discomfort	0.00% 0/47 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	2.3% 1/43 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/18 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.
General disorders Fatigue	0.00% 0/47 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	2.3% 1/43 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/18 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.
General disorders Influenza like illness	0.00% 0/47 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	2.3% 1/43 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/18 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.
General disorders Mucosal inflammation	0.00% 0/47 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	2.3% 1/43 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.	0.00% 0/18 • Up to Week 208 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.