Trial Outcomes & Findings for Study Of AG-013736 In Patients With 131I-Refractory Thyroid Cancer (NCT NCT00389441)

Last Updated: 2013-11-25

Results Overview

Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST). CR: disappearance of all target/non-target lesions and no appearance of new lesions. PR: at least (\>=)30 percent(%) decrease in sum of the longest dimensions (LDs) of the target lesions (taking as a reference the baseline sum), without progression of non-target lesions and no appearance of new lesions. Confirmed responses: those persist on repeat imaging study \>=4 weeks after initial documentation of response.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

52 participants

Primary outcome timeframe

Baseline until disease progression or initiation of antitumor therapy or death due to any cause, assessed every 8 weeks up to 28 days after last dose (follow-up)

Results posted on

2013-11-25

Participant Flow

Participant milestones

Participant milestones
Measure	Axitinib Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily continuously in 28-day cycles until tumor progression, unmanageable toxicity, or withdrawal of consent occurred. Dose was increased (to 7 mg or 10 mg twice daily) or decreased (to 3 mg or 2 mg twice daily) based on the tolerability.
Overall Study STARTED	52
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	52

Reasons for withdrawal

Reasons for withdrawal
Measure	Axitinib Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily continuously in 28-day cycles until tumor progression, unmanageable toxicity, or withdrawal of consent occurred. Dose was increased (to 7 mg or 10 mg twice daily) or decreased (to 3 mg or 2 mg twice daily) based on the tolerability.
Overall Study Adverse Event	7
Overall Study Death	4
Overall Study Lost to Follow-up	2
Overall Study Withdrawal by Subject	4
Overall Study Physician Decision	1
Overall Study Protocol Violation	1
Overall Study Global deterioration of health status	4
Overall Study Objective progression or relapse	26
Overall Study Ongoing in study A4061008 (NCT00828919)	2
Overall Study Clinical progression	1

Baseline Characteristics

Study Of AG-013736 In Patients With 131I-Refractory Thyroid Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Axitinib n=52 Participants Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily continuously in 28-day cycles until tumor progression, unmanageable toxicity, or withdrawal of consent occurred. Dose was increased (to 7 mg or 10 mg twice daily) or decreased (to 3 mg or 2 mg twice daily) based on the tolerability.
Age Continuous	57.6 years STANDARD_DEVIATION 12.1 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline until disease progression or initiation of antitumor therapy or death due to any cause, assessed every 8 weeks up to 28 days after last dose (follow-up)

Population: Intent-to-Treat (ITT) population included all participants who were enrolled in the study and received at least 1 dose of study treatment.

Outcome measures

Outcome measures
Measure	Axitinib n=52 Participants Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily continuously in 28-day cycles until tumor progression, unmanageable toxicity, or withdrawal of consent occurred. Dose was increased (to 7 mg or 10 mg twice daily) or decreased (to 3 mg or 2 mg twice daily) based on the tolerability.
Percentage of Participants With Objective Response (OR)	34.6 percentage of participants Interval 22.0 to 49.1

SECONDARY outcome

Timeframe: Baseline until disease progression or initiation of antitumor therapy or death due to any cause, assessed every 8 weeks up to 28 days after last dose (follow-up)

Population: ITT population included all participants who were enrolled in the study and received at least 1 dose of study treatment.

PFS: Time in weeks from the start of study treatment to first documentation of objective disease progression or to death due to any cause, whichever occurred first. PFS was calculated as (first event date minus the date of first dose of study treatment plus 1) divided by 7. Progression is defined using RECIST, as \>=20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD since start of study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.

Outcome measures

Outcome measures
Measure	Axitinib n=52 Participants Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily continuously in 28-day cycles until tumor progression, unmanageable toxicity, or withdrawal of consent occurred. Dose was increased (to 7 mg or 10 mg twice daily) or decreased (to 3 mg or 2 mg twice daily) based on the tolerability.
Progression Free Survival (PFS)	70.14 weeks Interval 64.14 to 93.71

SECONDARY outcome

Timeframe: Baseline until disease progression or initiation of antitumor therapy or death due to any cause, assessed every 8 weeks up to 28 days after last dose (follow-up)

Population: Subgroup of participants from the ITT population, with a confirmed objective tumor response (CR or PR).

Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.

Outcome measures

Outcome measures
Measure	Axitinib n=18 Participants Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily continuously in 28-day cycles until tumor progression, unmanageable toxicity, or withdrawal of consent occurred. Dose was increased (to 7 mg or 10 mg twice daily) or decreased (to 3 mg or 2 mg twice daily) based on the tolerability.
Duration of Response (DR)	74.71 weeks Interval 59.14 to 112.29

SECONDARY outcome

Timeframe: Baseline to death due to any cause or at least 2 year after the first dose for the last participant

Population: ITT population included all participants who were enrolled in the study and received at least 1 dose of study treatment.

Time in weeks from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).

Outcome measures

Outcome measures
Measure	Axitinib n=52 Participants Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily continuously in 28-day cycles until tumor progression, unmanageable toxicity, or withdrawal of consent occurred. Dose was increased (to 7 mg or 10 mg twice daily) or decreased (to 3 mg or 2 mg twice daily) based on the tolerability.
Overall Survival (OS)	118.43 weeks Interval 63.57 to 174.57

SECONDARY outcome

Timeframe: Baseline, Cycle 1 Day 15 (C1D15), C2D1, C2D15, thereafter D1 of each cycle up to 28 days after last dose (follow-up)

Population: ITT population included all participants who were enrolled in the study and received at least 1 dose of study treatment. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants evaluable at each time point.

Symptom severity score is comprised of average of 13 MDASI core items (pain, fatigue, nausea, disturbed sleep, distressed, shortness of breath, remembering things, lack of appetite, drowsy, dry mouth, sadness, vomiting, numbness or tingling). Participants were asked to rate severity of each symptom at their worst in last 24 hours; each item rated from 0 to 10, with 0 = symptom not present and 10 = as bad as you can imagine. Total average score range: 0 to 10. Lower scores indicated better outcome.

Outcome measures

Outcome measures
Measure	Axitinib n=49 Participants Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily continuously in 28-day cycles until tumor progression, unmanageable toxicity, or withdrawal of consent occurred. Dose was increased (to 7 mg or 10 mg twice daily) or decreased (to 3 mg or 2 mg twice daily) based on the tolerability.
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score Baseline (n= 49)	1.66 units on a scale Standard Deviation 1.301
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score Change at C1D15 (n= 40)	0.18 units on a scale Standard Deviation 1.158
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score Change at C2D1 (n= 42)	0.43 units on a scale Standard Deviation 1.274
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score Change at C2D15 (n= 37)	0.52 units on a scale Standard Deviation 1.407
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score Change at C3D1 (n= 43)	0.53 units on a scale Standard Deviation 1.602
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score Change at C4D1 (n= 39)	0.58 units on a scale Standard Deviation 1.199
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score Change at C5D1 (n= 36)	0.69 units on a scale Standard Deviation 1.550
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score Change at C6D1 (n= 36)	0.53 units on a scale Standard Deviation 1.484
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score Change at C7D1 (n= 29)	0.40 units on a scale Standard Deviation 1.344
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score Change at C8D1 (n= 28)	0.44 units on a scale Standard Deviation 1.395
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score Change at C9D1 (n= 27)	0.56 units on a scale Standard Deviation 1.516
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score Change at C10D1 (n= 25)	0.59 units on a scale Standard Deviation 1.494
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score Change at C11D1 (n= 25)	0.63 units on a scale Standard Deviation 1.669
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score Change at C12D1 (n= 24)	0.59 units on a scale Standard Deviation 1.584
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score Change at C13D1 (n= 24)	0.60 units on a scale Standard Deviation 1.281
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score Change at C14D1 (n= 24)	0.59 units on a scale Standard Deviation 1.476
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score Change at C15D1 (n= 24)	0.76 units on a scale Standard Deviation 1.654
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score Change at C16D1 (n= 23)	0.81 units on a scale Standard Deviation 1.911
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score Change at C17D1 (n= 20)	0.73 units on a scale Standard Deviation 1.816
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score Change at C18D1 (n= 20)	0.60 units on a scale Standard Deviation 1.729
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score Change at C19D1 (n= 18)	0.40 units on a scale Standard Deviation 1.201
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score Change at C20D1 (n= 16)	0.50 units on a scale Standard Deviation 0.864
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score Change at C21D1 (n= 16)	0.84 units on a scale Standard Deviation 1.094
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score Change at C22D1 (n= 15)	0.61 units on a scale Standard Deviation 0.970
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score Change at C23D1 (n= 14)	0.87 units on a scale Standard Deviation 1.086
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score Change at C24D1 (n= 11)	1.05 units on a scale Standard Deviation 0.990
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score Change at C25D1 (n= 11)	0.87 units on a scale Standard Deviation 1.016
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score Change at C26D1 (n= 9)	1.15 units on a scale Standard Deviation 0.960
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score Change at C27D1 (n= 9)	1.19 units on a scale Standard Deviation 1.244
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score Change at C28D1 (n= 10)	0.95 units on a scale Standard Deviation 1.291
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score Change at C29D1 (n= 10)	0.98 units on a scale Standard Deviation 1.080
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score Change at C30D1 (n= 10)	1.03 units on a scale Standard Deviation 0.970
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score Change at C31D1 (n= 9)	1.14 units on a scale Standard Deviation 1.100
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score Change at C32D1 (n= 9)	1.44 units on a scale Standard Deviation 1.058
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score Change at C33D1 (n= 9)	1.32 units on a scale Standard Deviation 1.233
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score Change at C34D1 (n= 8)	1.54 units on a scale Standard Deviation 1.366
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score Change at C35D1 (n= 6)	1.29 units on a scale Standard Deviation 1.233
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score Change at C36D1 (n= 6)	1.27 units on a scale Standard Deviation 1.610
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score Change at C37D1 (n= 5)	1.48 units on a scale Standard Deviation 1.347
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score Change at C38D1 (n= 5)	1.27 units on a scale Standard Deviation 1.117
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score Change at C39D1 (n= 5)	1.49 units on a scale Standard Deviation 1.288
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score Change at C40D1 (n= 5)	1.47 units on a scale Standard Deviation 1.176
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score Change at C41D1 (n= 5)	1.48 units on a scale Standard Deviation 1.267
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score Change at C42D1 (n= 5)	1.59 units on a scale Standard Deviation 1.312
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score Change at C43D1 (n= 5)	1.59 units on a scale Standard Deviation 1.259
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score Change at C44D1 (n= 5)	1.42 units on a scale Standard Deviation 1.258
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score Change at C45D1 (n= 4)	1.49 units on a scale Standard Deviation 1.349
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score Change at C46D1 (n= 4)	1.73 units on a scale Standard Deviation 1.425
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score Change at C47D1 (n= 4)	1.70 units on a scale Standard Deviation 1.543
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score Change at C48D1 (n= 3)	1.90 units on a scale Standard Deviation 1.377
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score Change at C49D1 (n= 3)	2.26 units on a scale Standard Deviation 1.554
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score Change at C50D1 (n= 3)	2.38 units on a scale Standard Deviation 1.425
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score Change at C51D1 (n= 3)	2.46 units on a scale Standard Deviation 1.533
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score Change at C52D1 (n= 1)	3.38 units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score Change at C53D1 (n= 1)	3.54 units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score Change at C54D1 (n= 1)	3.00 units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score Change at C55D1 (n= 1)	3.38 units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score Change at C56D1 (n= 1)	3.15 units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score Change at C57D1 (n= 1)	3.62 units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score Change at C58D1 (n= 1)	3.23 units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score Change at C59D1 (n= 1)	3.08 units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score Change at C60D1 (n= 1)	3.85 units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score Change at C61D1 (n= 1)	3.31 units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score Change at C62D1 (n= 1)	3.46 units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score Change at follow-up (n= 12)	0.37 units on a scale Standard Deviation 0.939

SECONDARY outcome

Timeframe: Baseline, Cycle 1 Day 15 (C1D15), C2D1, C2D15, thereafter D1 of each cycle up to 28 days after last dose (follow-up)

Symptom interference score is comprised of average of 6 function items from MDASI core (general activity, mood, work, relations with others, walking, and enjoyment of life). Participants were asked to rate how much symptoms have interfered in last 24 hours; each item rated from 0 to 10, with 0 = did not interfere and 10 = interfered completely. Total average score range: 0 to 10. Lower scores indicated better outcome.

Outcome measures

Outcome measures
Measure	Axitinib n=48 Participants Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily continuously in 28-day cycles until tumor progression, unmanageable toxicity, or withdrawal of consent occurred. Dose was increased (to 7 mg or 10 mg twice daily) or decreased (to 3 mg or 2 mg twice daily) based on the tolerability.
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score Baseline (n= 48)	2.24 units on a scale Standard Deviation 2.193
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score Change at C1D15 (n= 40)	-0.05 units on a scale Standard Deviation 2.161
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score Change at C2D1 (n= 41)	0.28 units on a scale Standard Deviation 2.763
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score Change at C2D15 (n= 36)	0.67 units on a scale Standard Deviation 2.403
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score Change at C3D1 (n= 42)	0.46 units on a scale Standard Deviation 2.669
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score Change at C4D1 (n= 37)	0.47 units on a scale Standard Deviation 2.311
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score Change at C5D1 (n= 36)	0.50 units on a scale Standard Deviation 2.377
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score Change at C6D1 (n= 36)	0.65 units on a scale Standard Deviation 2.605
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score Change at C7D1 (n= 29)	0.19 units on a scale Standard Deviation 2.386
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score Change at C8D1 (n= 28)	0.22 units on a scale Standard Deviation 2.242
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score Change at C9D1 (n= 27)	0.46 units on a scale Standard Deviation 2.450
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score Change at C10D1 (n= 25)	0.35 units on a scale Standard Deviation 2.386
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score Change at C11D1 (n= 25)	0.51 units on a scale Standard Deviation 2.784
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score Change at C12D1 (n= 23)	0.32 units on a scale Standard Deviation 2.593
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score Change at C13D1 (n= 24)	0.42 units on a scale Standard Deviation 2.346
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score Change at C14D1 (n= 24)	0.42 units on a scale Standard Deviation 2.624
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score Change at C15D1 (n= 24)	0.69 units on a scale Standard Deviation 2.902
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score Change at C16D1 (n= 23)	0.73 units on a scale Standard Deviation 3.179
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score Change at C17D1 (n= 20)	0.26 units on a scale Standard Deviation 2.920
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score Change at C18D1 (n= 20)	0.35 units on a scale Standard Deviation 2.638
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score Change at C19D1 (n= 18)	-0.18 units on a scale Standard Deviation 2.497
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score Change at C20D1 (n= 15)	0.30 units on a scale Standard Deviation 2.124
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score Change at C21D1 (n= 15)	0.50 units on a scale Standard Deviation 1.954
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score Change at C22D1 (n= 14)	0.32 units on a scale Standard Deviation 1.979
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score Change at C23D1 (n= 14)	0.95 units on a scale Standard Deviation 1.615
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score Change at C24D1 (n= 11)	0.77 units on a scale Standard Deviation 1.844
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score Change at C25D1 (n= 11)	0.65 units on a scale Standard Deviation 1.699
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score Change at C26D1 (n= 9)	1.04 units on a scale Standard Deviation 1.681
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score Change at C27D1 (n= 9)	0.81 units on a scale Standard Deviation 2.463
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score Change at C28D1 (n= 28)	0.67 units on a scale Standard Deviation 1.956
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score Change at C29D1 (n= 29)	0.88 units on a scale Standard Deviation 1.926
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score Change at C30D1 (n= 30)	1.03 units on a scale Standard Deviation 1.846
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score Change at C31D1 (n= 9)	1.19 units on a scale Standard Deviation 1.910
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score Change at C32D1 (n= 9)	1.52 units on a scale Standard Deviation 1.870
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score Change at C33D1 (n= 9)	1.07 units on a scale Standard Deviation 1.972
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score Change at C34D1 (n= 8)	1.81 units on a scale Standard Deviation 1.846
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score Change at C35D1 (n= 6)	1.17 units on a scale Standard Deviation 1.517
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score Change at C36D1 (n= 6)	0.97 units on a scale Standard Deviation 1.572
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score Change at C37D1 (n= 5)	1.40 units on a scale Standard Deviation 1.782
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score Change at C38D1 (n= 5)	1.23 units on a scale Standard Deviation 1.521
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score Change at C39D1 (n= 5)	1.50 units on a scale Standard Deviation 1.453
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score Change at C40D1 (n= 5)	1.83 units on a scale Standard Deviation 1.889
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score Change at C41D1 (n= 5)	1.53 units on a scale Standard Deviation 1.746
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score Change at C42D1 (n= 5)	1.67 units on a scale Standard Deviation 1.637
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score Change at C43D1 (n= 5)	1.31 units on a scale Standard Deviation 1.267
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score Change at C44D1 (n= 5)	1.34 units on a scale Standard Deviation 1.345
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score Change at C45D1 (n= 4)	1.50 units on a scale Standard Deviation 1.694
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score Change at C46D1 (n= 4)	2.17 units on a scale Standard Deviation 2.113
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score Change at C47D1 (n= 4)	1.63 units on a scale Standard Deviation 1.950
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score Change at C48D1 (n= 3)	2.00 units on a scale Standard Deviation 1.041
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score Change at C49D1 (n= 3)	2.56 units on a scale Standard Deviation 1.798
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score Change at C50D1 (n= 3)	0.22 units on a scale Standard Deviation 1.206
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score Change at C51D1 (n= 3)	2.44 units on a scale Standard Deviation 1.251
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score Change at C52D1 (n= 1)	3.33 units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score Change at C53D1 (n= 1)	3.33 units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score Change at C54D1 (n= 1)	3.33 units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score Change at C55D1 (n= 1)	3.50 units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score Change at C56D1 (n= 1)	3.50 units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score Change at C57D1 (n= 1)	4.50 units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score Change at C58D1 (n= 1)	3.67 units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score Change at C59D1 (n= 1)	3.33 units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score Change at C60D1 (n= 1)	4.83 units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score Change at C61D1 (n= 1)	3.33 units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score Change at C62D1 (n= 1)	4.00 units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score Change at follow-up (n= 12)	0.32 units on a scale Standard Deviation 2.396

Adverse Events

Axitinib

Serious events: 22 serious events

Other events: 52 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Axitinib n=52 participants at risk Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily continuously in 28-day cycles until tumor progression, unmanageable toxicity, or withdrawal of consent occurred. Dose was increased (to 7 mg or 10 mg twice daily) or decreased (to 3 mg or 2 mg twice daily) based on the tolerability.
Cardiac disorders Cardiac failure congestive	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Hypertensive heart disease	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Myocardial infarction	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Myocardial ischaemia	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Haematemesis	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Oral pain	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Pancreatitis	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Chest pain	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Disease progression	3.8% 2/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Fatigue	5.8% 3/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Immune system disorders Hypersensitivity	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Appendicitis	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Upper respiratory tract infection	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Fracture	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Weight decreased	3.8% 2/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Flank pain	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Cerebral ischaemia	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Monoplegia	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Neuropathy peripheral	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.8% 3/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Hydrothorax	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Laryngeal obstruction	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Skin ulcer	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Arteriosclerosis	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Jugular vein thrombosis	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Other adverse events

Other adverse events
Measure	Axitinib n=52 participants at risk Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily continuously in 28-day cycles until tumor progression, unmanageable toxicity, or withdrawal of consent occurred. Dose was increased (to 7 mg or 10 mg twice daily) or decreased (to 3 mg or 2 mg twice daily) based on the tolerability.
Blood and lymphatic system disorders Anaemia	5.8% 3/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Leukocytosis	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Leukopenia	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Lymphadenopathy	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Lymphopenia	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Neutropenia	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Paratracheal lymphadenopathy	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Thrombocytopenia	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Atrial thrombosis	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Sinus bradycardia	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Sinus tachycardia	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Tachycardia	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Congenital, familial and genetic disorders Phimosis	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Ear and labyrinth disorders Ear pain	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Ear and labyrinth disorders Hypoacusis	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Ear and labyrinth disorders Tinnitus	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Ear and labyrinth disorders Vertigo	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Endocrine disorders Hyperparathyroidism	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Endocrine disorders Hyperparathyroidism secondary	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Endocrine disorders Hypothyroidism	5.8% 3/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Cataract	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Conjunctival haemorrhage	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Conjunctivitis	3.8% 2/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Diplopia	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Eye swelling	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Lacrimation increased	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Orbital oedema	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Periorbital oedema	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Vision blurred	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Vitreous floaters	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal discomfort	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal distension	3.8% 2/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain	9.6% 5/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain upper	15.4% 8/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Barrett's oesophagus	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Chapped lips	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Colitis	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Colonic polyp	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Constipation	13.5% 7/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Diarrhoea	59.6% 31/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Dry mouth	7.7% 4/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Dyspepsia	3.8% 2/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Dysphagia	3.8% 2/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Gastrooesophageal reflux disease	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Gingival bleeding	3.8% 2/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Glossodynia	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Haematochezia	5.8% 3/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Haemorrhoids	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Mouth ulceration	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Nausea	26.9% 14/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Odynophagia	3.8% 2/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Oral pain	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Proctitis	3.8% 2/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Rectal haemorrhage	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Stomatitis	11.5% 6/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Tongue ulceration	3.8% 2/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Toothache	3.8% 2/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Vomiting	13.5% 7/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Asthenia	7.7% 4/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Chest discomfort	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Chest pain	5.8% 3/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Facial pain	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Fatigue	44.2% 23/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Feeling cold	3.8% 2/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Gait disturbance	3.8% 2/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Mucosal inflammation	19.2% 10/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Oedema peripheral	7.7% 4/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Pain	5.8% 3/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Pyrexia	7.7% 4/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Cholecystitis	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Cholelithiasis	3.8% 2/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Anal abscess	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Bronchitis	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Candidiasis	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Dermatitis infected	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Fungal infection	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Gastroenteritis	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Herpes simplex ophthalmic	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Herpes zoster	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Influenza	9.6% 5/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Laryngitis	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Lung infection	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Nasopharyngitis	7.7% 4/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Otitis externa	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Otitis media	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Parotitis	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Pharyngitis	3.8% 2/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Pneumonia	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Sinusitis	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Subcutaneous abscess	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Tonsillitis	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Tooth abscess	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Upper respiratory tract infection	7.7% 4/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Urinary tract infection	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Viral infection	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Contusion	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Excoriation	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Fall	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Hand fracture	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Joint dislocation	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Overdose	3.8% 2/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Post procedural haemorrhage	5.8% 3/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Procedural pain	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Alanine aminotransferase	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Alanine aminotransferase increased	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Aspartate aminotransferase	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Aspartate aminotransferase increased	3.8% 2/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood alkaline phosphatase increased	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood bilirubin increased	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood cholesterol increased	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood creatinine increased	5.8% 3/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood lactate dehydrogenase increased	3.8% 2/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood phosphorus increased	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood pressure decreased	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood pressure diastolic increased	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood pressure increased	7.7% 4/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood thyroid stimulating hormone decreased	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood thyroid stimulating hormone increased	5.8% 3/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Crystal urine present	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Gamma-glutamyltransferase increased	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Haematocrit increased	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Haemoglobin increased	9.6% 5/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Platelet count decreased	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Protein urine present	3.8% 2/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Thyroglobulin increased	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Thyroxine increased	3.8% 2/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Weight decreased	34.6% 18/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Decreased appetite	36.5% 19/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Dehydration	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Gout	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypercholesterolaemia	3.8% 2/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hyperglycaemia	3.8% 2/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hyperkalaemia	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypoalbuminaemia	3.8% 2/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypocalcaemia	7.7% 4/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypokalaemia	3.8% 2/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hyponatraemia	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Malnutrition	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Vitamin D deficiency	3.8% 2/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Arthralgia	13.5% 7/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Back pain	17.3% 9/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Bone pain	3.8% 2/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Mastication disorder	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Muscle spasms	5.8% 3/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	3.8% 2/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	5.8% 3/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Myalgia	5.8% 3/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Neck pain	3.8% 2/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Osteoporosis	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Pain in extremity	30.8% 16/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Pain in jaw	3.8% 2/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Spondylolisthesis	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipofibroma	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pyogenic granuloma	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Ataxia	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Burning sensation	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Disturbance in attention	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Dizziness	7.7% 4/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Dysgeusia	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Headache	19.2% 10/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Hypoaesthesia	3.8% 2/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Lethargy	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Motor dysfunction	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Neuralgia	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Neuropathy peripheral	7.7% 4/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Paraesthesia	13.5% 7/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Somnolence	3.8% 2/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Syncope	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Thrombotic cerebral infarction	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Tremor	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Anxiety	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Depression	9.6% 5/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Insomnia	9.6% 5/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Mood altered	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Sleep disorder	3.8% 2/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Dysuria	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Haematuria	3.8% 2/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Pollakiuria	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Proteinuria	11.5% 6/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Urinary retention	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Urinary tract pain	3.8% 2/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Reproductive system and breast disorders Amenorrhoea	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Reproductive system and breast disorders Dyspareunia	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Reproductive system and breast disorders Erectile dysfunction	3.8% 2/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Reproductive system and breast disorders Menstrual disorder	3.8% 2/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Reproductive system and breast disorders Pelvic pain	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Reproductive system and breast disorders Vulvovaginal dryness	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Cough	21.2% 11/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Dry throat	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Dysphonia	13.5% 7/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	23.1% 12/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Epistaxis	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Haemoptysis	11.5% 6/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Oropharyngeal discomfort	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	11.5% 6/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Pleural effusion	3.8% 2/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	3.8% 2/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Tachypnoea	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Throat irritation	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Alopecia	13.5% 7/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Dermal cyst	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Dermatitis	3.8% 2/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Dry skin	9.6% 5/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Eczema	5.8% 3/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Erythema	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Hair colour changes	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Hyperkeratosis	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Nail disorder	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Nail pigmentation	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	11.5% 6/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Petechiae	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Pruritus	7.7% 4/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Rash	15.4% 8/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Skin disorder	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Skin exfoliation	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Skin fissures	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Skin haemorrhage	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Skin lesion	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Skin reaction	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Skin swelling	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Skin ulcer	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Surgical and medical procedures Mole excision	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Hypertension	53.8% 28/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Hypertensive crisis	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Peripheral artery thrombosis	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Thrombosis	1.9% 1/52 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

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

Restriction type: OTHER