Trial Outcomes & Findings for A Study Evaluating The PF-03084014 In Combination With Docetaxel In Patients With Advanced Breast Cancer (NCT NCT01876251)

NCT ID: NCT01876251

Last Updated: 2019-03-15

Results Overview

Any DLT event in Cycle 1: Grade 4 neutropenia lasting more than (\>)7 days; febrile neutropenia (Grade more than or equal to \[\>=\] 3 and body temperature \>=38.5 degrees Celsius); Grade \>=3 neutropenic infection; Grade \>=3 thrombocytopenia with bleeding; Grade 4 thrombocytopenia without bleeding; Grade \>=3 toxicities (except those that had not been maximally treated); Grade 3 prolongation of time from electrocardiogram (ECG) Q wave to the end of the T wave corresponding to electrical systole (QT) corrected for heart rate (QTc) which persisted after correction of reversible causes; delay of 2 weeks in receiving next scheduled cycle due to persisting treatment-related toxicities; and failure to deliver at least 80% of planned dose during first cycle due to treatment-related toxicities.

• Recruitment status: TERMINATED
• Study phase: PHASE1
• Target enrollment: 30 participants
• Primary outcome timeframe: Cycle 1 Days 1-21
• Results posted on: 2019-03-15

Participant Flow

30 participants were enrolled of whom 1 was not treated and therefore 29 participants are stated below as starting the study.

Participant milestones

Measure	PF-03084014 100 mg BID + Docetaxel 75 mg/m^2 PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\^2) intravenously.	PF-03084014 100 mg BID + Docetaxel 100 mg/m^2 PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 100 mg/square meters (m\^2) intravenously.	PF-03084014 150 mg BID + Docetaxel 75 mg/m^2 PF-03084014 150 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\^2) intravenously.
Overall Study STARTED	15	3	11
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	15	3	11

Reasons for withdrawal

Measure	PF-03084014 100 mg BID + Docetaxel 75 mg/m^2 PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\^2) intravenously.	PF-03084014 100 mg BID + Docetaxel 100 mg/m^2 PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 100 mg/square meters (m\^2) intravenously.	PF-03084014 150 mg BID + Docetaxel 75 mg/m^2 PF-03084014 150 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\^2) intravenously.
Overall Study Clinical progression	1	0	0
Overall Study Death	2	0	1
Overall Study Participant started new treatment	1	0	1
Overall Study Participant refused further follow-up	0	0	1
Overall Study Study terminated	1	0	0
Overall Study Objective progression or relapse	10	3	8

Baseline Characteristics

A Study Evaluating The PF-03084014 In Combination With Docetaxel In Patients With Advanced Breast Cancer

Baseline characteristics by cohort

Measure	PF-03084014 100 mg BID + Docetaxel 75 mg/m^2 n=15 Participants PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\^2) intravenously.	PF-03084014 100 mg BID + Docetaxel 100 mg/m^2 n=3 Participants PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 100 mg/square meters (m\^2) intravenously.	PF-03084014 150 mg BID + Docetaxel 75 mg/m^2 n=11 Participants PF-03084014 150 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\^2) intravenously.	Total n=29 Participants Total of all reporting groups
Age, Continuous	53.3 years STANDARD_DEVIATION 13.9 • n=93 Participants	43.3 years STANDARD_DEVIATION 17.9 • n=4 Participants	46.2 years STANDARD_DEVIATION 12.6 • n=27 Participants	49.6 years STANDARD_DEVIATION 13.9 • n=483 Participants
Sex: Female, Male Female	15 Participants n=93 Participants	3 Participants n=4 Participants	11 Participants n=27 Participants	29 Participants n=483 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants

PRIMARY outcome

Timeframe: Cycle 1 Days 1-21

Population: All enrolled participants who were eligible, received study treatment, and who either experienced DLT during the first cycle, or completed the 1-cycle observation period.

Any DLT event in Cycle 1: Grade 4 neutropenia lasting more than (>)7 days; febrile neutropenia (Grade more than or equal to [>=] 3 and body temperature >=38.5 degrees Celsius); Grade >=3 neutropenic infection; Grade >=3 thrombocytopenia with bleeding; Grade 4 thrombocytopenia without bleeding; Grade >=3 toxicities (except those that had not been maximally treated); Grade 3 prolongation of time from electrocardiogram (ECG) Q wave to the end of the T wave corresponding to electrical systole (QT) corrected for heart rate (QTc) which persisted after correction of reversible causes; delay of 2 weeks in receiving next scheduled cycle due to persisting treatment-related toxicities; and failure to deliver at least 80% of planned dose during first cycle due to treatment-related toxicities.

Outcome measures

Measure	PF-03084014 100 mg BID + Docetaxel 75 mg/m^2 n=8 Participants PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\^2) intravenously.	PF-03084014 100 mg BID + Docetaxel 100 mg/m^2 n=3 Participants PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 100 mg/square meters (m\^2) intravenously.	PF-03084014 150 mg BID + Docetaxel 75 mg/m^2 n=11 Participants PF-03084014 150 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\^2) intravenously.
Number of Participants With Dose-limiting Toxicities (DLTs) in Cycle 1	1 participants	1 participants	4 participants

PRIMARY outcome

Timeframe: Baseline till 6 months post-dose

Population: The 6-month PFS was evaluated only for the participants in the expansion cohort (PF-03084014 100 mg BID + docetaxel 75 mg/m\^2). Due to early study termination, only 7 participants were treated in the expansion cohort.

The period from study entry until disease progression, death or date of last contact. Assessment of response was made using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Outcome measures

Measure	PF-03084014 100 mg BID + Docetaxel 75 mg/m^2 n=7 Participants PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\^2) intravenously.	PF-03084014 100 mg BID + Docetaxel 100 mg/m^2 PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 100 mg/square meters (m\^2) intravenously.	PF-03084014 150 mg BID + Docetaxel 75 mg/m^2 PF-03084014 150 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\^2) intravenously.
Progression-free Survival (PFS) at 6 Months - Expansion Cohort	4.1 months Interval 1.3 to 8.1	—	—

SECONDARY outcome

Timeframe: Baseline up to 28-35 days after treatment discontinuation (up to Day 280)

Population: All 29 participants who received study treatment were included in the AE summarization/analysis.

An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent AEs (TEAEs) are defined as newly occurring AEs or those worsening after first dose. AEs comprised both SAEs and non-SAEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Causality assessment was made by the investigator. Grading was per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) version 3.0: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life-threatening, Grade 5=death related to AE.

Outcome measures

Measure	PF-03084014 100 mg BID + Docetaxel 75 mg/m^2 n=15 Participants PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\^2) intravenously.	PF-03084014 100 mg BID + Docetaxel 100 mg/m^2 n=3 Participants PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 100 mg/square meters (m\^2) intravenously.	PF-03084014 150 mg BID + Docetaxel 75 mg/m^2 n=11 Participants PF-03084014 150 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\^2) intravenously.
Number of Participants With All Causality and Treatment-related Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs All causality TEAEs	15 participants	3 participants	11 participants
Number of Participants With All Causality and Treatment-related Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs Treatment-related (TR) TEAEs	15 participants	3 participants	11 participants
Number of Participants With All Causality and Treatment-related Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs All causality SAEs	4 participants	3 participants	6 participants
Number of Participants With All Causality and Treatment-related Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs TR SAEs	3 participants	3 participants	6 participants
Number of Participants With All Causality and Treatment-related Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs Grade 3 or 4 TEAEs, all causality	15 participants	3 participants	11 participants
Number of Participants With All Causality and Treatment-related Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs Grade 3 or 4 TEAEs, TR	15 participants	3 participants	11 participants
Number of Participants With All Causality and Treatment-related Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs Grade 5 TEAEs, all causality	1 participants	0 participants	1 participants
Number of Participants With All Causality and Treatment-related Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs Grade 5 TEAEs, TR	0 participants	0 participants	1 participants
Number of Participants With All Causality and Treatment-related Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs Permanent withdrawal due to all causality TEAE(s)	1 participants	1 participants	6 participants
Number of Participants With All Causality and Treatment-related Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs Permanent withdrawal due to TR TEAE(s)	1 participants	1 participants	4 participants

SECONDARY outcome

Timeframe: Baseline up to 28-35 days after treatment discontinuation (up to Day 280)

Population: All 29 participants who received study treatment were included in the safety analyses.

Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters included hematology, coagulation, liver function, renal function, electrolytes, clinical chemistry, and urinalysis (dipstick).

Outcome measures

Measure	PF-03084014 100 mg BID + Docetaxel 75 mg/m^2 n=15 Participants PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\^2) intravenously.	PF-03084014 100 mg BID + Docetaxel 100 mg/m^2 n=3 Participants PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 100 mg/square meters (m\^2) intravenously.	PF-03084014 150 mg BID + Docetaxel 75 mg/m^2 n=11 Participants PF-03084014 150 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\^2) intravenously.
Number of Participants With Laboratory Abnormalities	15 participants	3 participants	11 participants

SECONDARY outcome

Timeframe: Baseline, every 6 weeks from Cycle 2 onwards up to 26 months

Population: All 29 participants who received study treatment were included in this analysis.

OR was based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 millimeters [mm]). No new lesions. PR was defined as more than or equal to (>=) 30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.

Outcome measures

Measure	PF-03084014 100 mg BID + Docetaxel 75 mg/m^2 n=15 Participants PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\^2) intravenously.	PF-03084014 100 mg BID + Docetaxel 100 mg/m^2 n=3 Participants PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 100 mg/square meters (m\^2) intravenously.	PF-03084014 150 mg BID + Docetaxel 75 mg/m^2 n=11 Participants PF-03084014 150 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\^2) intravenously.
Percentage of Participants With Objective Response (OR)	13.3 percentage of participants Interval 1.7 to 40.5	0 percentage of participants Interval 0.0 to 70.8	18.2 percentage of participants Interval 2.3 to 51.8

SECONDARY outcome

Timeframe: Cycle (C) 1 Days (D) 1, 2, 8, and 21; Day 1 of subsequent cycles and at EOT (max reached: Cycle 12)

Population: All 22 participants treated in the dose escalation stage were included in the analysis. n=number of evaluable participants at the specified time point.

Serum PF-03084014 pharmacokinetic (PK) parameters were calculated following twice daily (BID) doses of PF-03084014 given alone (Cycle 1 Day 21) and in combination with docetaxel (Cycle 1 Day 2 and Cycle 2 Day 1).

Outcome measures

Measure	PF-03084014 100 mg BID + Docetaxel 75 mg/m^2 n=8 Participants PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\^2) intravenously.	PF-03084014 100 mg BID + Docetaxel 100 mg/m^2 n=3 Participants PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 100 mg/square meters (m\^2) intravenously.	PF-03084014 150 mg BID + Docetaxel 75 mg/m^2 n=11 Participants PF-03084014 150 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\^2) intravenously.
Area Under the Concentration-time Curve (AUC) From Time 0 to Time of Last Measured Concentration (AUClast) of PF-03084014 in Dose-finding Cohort C1D2	1779 nanogram (ng)*hour (hr)/milliliter (mL) Geometric Coefficient of Variation 63	1380 nanogram (ng)*hour (hr)/milliliter (mL) Geometric Coefficient of Variation 57	1839 nanogram (ng)*hour (hr)/milliliter (mL) Geometric Coefficient of Variation 32
Area Under the Concentration-time Curve (AUC) From Time 0 to Time of Last Measured Concentration (AUClast) of PF-03084014 in Dose-finding Cohort C1D21	4119 nanogram (ng)*hour (hr)/milliliter (mL) Geometric Coefficient of Variation 39	3234 nanogram (ng)*hour (hr)/milliliter (mL) Geometric Coefficient of Variation 21	5575 nanogram (ng)*hour (hr)/milliliter (mL) Geometric Coefficient of Variation 59
Area Under the Concentration-time Curve (AUC) From Time 0 to Time of Last Measured Concentration (AUClast) of PF-03084014 in Dose-finding Cohort C2D1	1983 nanogram (ng)*hour (hr)/milliliter (mL) Geometric Coefficient of Variation 53	NA nanogram (ng)*hour (hr)/milliliter (mL) Geometric Coefficient of Variation NA There were only 2 participants with reportable AUClast at this time point and summary statistics are not calculated for \<3 participants. Individual values were 1350 and 1400 ng\*hr/mL.	2652 nanogram (ng)*hour (hr)/milliliter (mL) Geometric Coefficient of Variation 28

SECONDARY outcome

Timeframe: C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12)

Population: All 22 participants treated in the dose escalation stage were included in the analysis. n=number of evaluable participants at the specified time point.

Plasma docetaxel PK parameters were calculated following a 1-hr infusion of docetaxel given alone (Cycle 1 Day 1) and in combination with BID dosing of PF-03084014 (Cycle 2 Day 1)

Outcome measures

Measure	PF-03084014 100 mg BID + Docetaxel 75 mg/m^2 n=8 Participants PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\^2) intravenously.	PF-03084014 100 mg BID + Docetaxel 100 mg/m^2 n=3 Participants PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 100 mg/square meters (m\^2) intravenously.	PF-03084014 150 mg BID + Docetaxel 75 mg/m^2 n=11 Participants PF-03084014 150 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\^2) intravenously.
AUClast and AUC From Time 0 Extrapolated to Infinite Time (AUCinf) of Docetaxel in Dose-finding Cohort AUClast, C1D1	3535 nanogram (ng)*hour (hr)/milliliter (mL) Geometric Coefficient of Variation 113	4082 nanogram (ng)*hour (hr)/milliliter (mL) Geometric Coefficient of Variation 36	2121 nanogram (ng)*hour (hr)/milliliter (mL) Geometric Coefficient of Variation 49
AUClast and AUC From Time 0 Extrapolated to Infinite Time (AUCinf) of Docetaxel in Dose-finding Cohort AUClast, C2D1	2377 nanogram (ng)*hour (hr)/milliliter (mL) Geometric Coefficient of Variation 29	NA nanogram (ng)*hour (hr)/milliliter (mL) Geometric Coefficient of Variation NA There were only 2 participants with reportable AUClast at this time point and summary statistics are not calculated for \<3 participants. Individual values were 2270 and 1730 ng\*hr/mL.	2136 nanogram (ng)*hour (hr)/milliliter (mL) Geometric Coefficient of Variation 47
AUClast and AUC From Time 0 Extrapolated to Infinite Time (AUCinf) of Docetaxel in Dose-finding Cohort AUCinf, C1D1	NA nanogram (ng)*hour (hr)/milliliter (mL) Geometric Coefficient of Variation NA There were only 2 participants with reportable AUCinf at this time point and summary statistics are not calculated for \<3 participants. Individual values were 30800 and 3020 ng\*hr/mL.	NA nanogram (ng)*hour (hr)/milliliter (mL) Geometric Coefficient of Variation NA There were only 2 participants with reportable AUCinf at this time point and summary statistics are not calculated for \<3 participants. Individual values were 2970 and 4490 ng\*hr/mL.	2509 nanogram (ng)*hour (hr)/milliliter (mL) Geometric Coefficient of Variation 63
AUClast and AUC From Time 0 Extrapolated to Infinite Time (AUCinf) of Docetaxel in Dose-finding Cohort AUCinf, C2D1	2530 nanogram (ng)*hour (hr)/milliliter (mL) Geometric Coefficient of Variation 30	NA nanogram (ng)*hour (hr)/milliliter (mL) Geometric Coefficient of Variation NA There was only 1 participant with reportable AUCinf at this time point and summary statistics are not calculated for \<3 participants. Individual value was 2410 ng\*hr/mL.	2929 nanogram (ng)*hour (hr)/milliliter (mL) Geometric Coefficient of Variation 3

SECONDARY outcome

Timeframe: C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12)

Population: All 22 participants treated in the dose escalation stage were included in the analysis. n=number of evaluable participants at the specified time point.

Serum PF-03084014 PK parameters were calculated following BID doses of PF-03084014 given alone (Cycle 1 Day 21) and in combination with docetaxel (Cycle 1 Day 2 and Cycle 2 Day 1)

Outcome measures

Measure	PF-03084014 100 mg BID + Docetaxel 75 mg/m^2 n=8 Participants PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\^2) intravenously.	PF-03084014 100 mg BID + Docetaxel 100 mg/m^2 n=3 Participants PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 100 mg/square meters (m\^2) intravenously.	PF-03084014 150 mg BID + Docetaxel 75 mg/m^2 n=11 Participants PF-03084014 150 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\^2) intravenously.
Maximum Serum or Plasma Concentration (Cmax) and Predose Concentration (Ctrough) of PF-03084014 in Dose-finding Cohort Cmax, C1D2	884.8 ng/mL Geometric Coefficient of Variation 56	744.2 ng/mL Geometric Coefficient of Variation 51	896.6 ng/mL Geometric Coefficient of Variation 40
Maximum Serum or Plasma Concentration (Cmax) and Predose Concentration (Ctrough) of PF-03084014 in Dose-finding Cohort Cmax, C1D21	1053 ng/mL Geometric Coefficient of Variation 51	677.5 ng/mL Geometric Coefficient of Variation 37	1501 ng/mL Geometric Coefficient of Variation 44
Maximum Serum or Plasma Concentration (Cmax) and Predose Concentration (Ctrough) of PF-03084014 in Dose-finding Cohort Ctrough, C1D21	214.7 ng/mL Geometric Coefficient of Variation 39	170.8 ng/mL Geometric Coefficient of Variation 36	306.1 ng/mL Geometric Coefficient of Variation 72
Maximum Serum or Plasma Concentration (Cmax) and Predose Concentration (Ctrough) of PF-03084014 in Dose-finding Cohort Cmax, C2D1	885.7 ng/mL Geometric Coefficient of Variation 95	NA ng/mL Geometric Coefficient of Variation NA There were only 2 participants with reportable Cmax at this time point and summary statistics are not calculated for \<3 participants. Individual values were 488 and 559 ng/mL.	1100 ng/mL Geometric Coefficient of Variation 21
Maximum Serum or Plasma Concentration (Cmax) and Predose Concentration (Ctrough) of PF-03084014 in Dose-finding Cohort Ctrough, C2D1	186.1 ng/mL Geometric Coefficient of Variation 42	NA ng/mL Geometric Coefficient of Variation NA There were only 2 participants with reportable Ctrough at this time point and summary statistics are not calculated for \<3 participants. Individual values were 116 and 129 ng/mL.	226.4 ng/mL Geometric Coefficient of Variation 65

SECONDARY outcome

Timeframe: C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12)

Population: All 22 participants treated in the dose escalation stage were included in the analysis. n=number of evaluable participants at the specified time point.

Plasma docetaxel PK parameters were calculated following a 1-hr infusion of docetaxel given alone (Cycle 1 Day 1) and in combination with BID dosing of PF-03084014 (Cycle 2 Day 1)

Outcome measures

Measure	PF-03084014 100 mg BID + Docetaxel 75 mg/m^2 n=8 Participants PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\^2) intravenously.	PF-03084014 100 mg BID + Docetaxel 100 mg/m^2 n=3 Participants PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 100 mg/square meters (m\^2) intravenously.	PF-03084014 150 mg BID + Docetaxel 75 mg/m^2 n=11 Participants PF-03084014 150 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\^2) intravenously.
Cmax of Docetaxel in Dose-finding Cohort Cmax, C1D1	3711 ng/mL Geometric Coefficient of Variation 183	3447 ng/mL Geometric Coefficient of Variation 57	2103 ng/mL Geometric Coefficient of Variation 68
Cmax of Docetaxel in Dose-finding Cohort Cmax, C2D1	2606 ng/mL Geometric Coefficient of Variation 29	NA ng/mL Geometric Coefficient of Variation NA There were only 2 participants with reportable Cmax at this time point and summary statistics are not calculated for \<3 participants. Individual values were 2260 and 2200 ng/mL.	1965 ng/mL Geometric Coefficient of Variation 35

SECONDARY outcome

Timeframe: C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12)

Population: All 22 participants treated in the dose escalation stage were included in the analysis. n=number of evaluable participants at the specified time point.

Serum PF-03084014 PK parameters were calculated following BID doses of PF-03084014 given alone (Cycle 1 Day 21) and in combination with docetaxel (Cycle 1 Day 2 and Cycle 2 Day 1)

Outcome measures

Measure	PF-03084014 100 mg BID + Docetaxel 75 mg/m^2 n=8 Participants PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\^2) intravenously.	PF-03084014 100 mg BID + Docetaxel 100 mg/m^2 n=3 Participants PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 100 mg/square meters (m\^2) intravenously.	PF-03084014 150 mg BID + Docetaxel 75 mg/m^2 n=11 Participants PF-03084014 150 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\^2) intravenously.
Time to Cmax (Tmax) of PF-03084014 in Dose-finding Cohort Tmax, C1D2	1.00 hr Interval 0.5 to 1.03	1.02 hr Interval 1.0 to 4.0	1.00 hr Interval 0.5 to 1.03
Time to Cmax (Tmax) of PF-03084014 in Dose-finding Cohort Tmax, C1D21	0.533 hr Interval 0.417 to 1.0	1.00 hr Interval 0.5 to 4.03	0.767 hr Interval 0.5 to 2.0
Time to Cmax (Tmax) of PF-03084014 in Dose-finding Cohort Tmax, C2D1	0.883 hr Interval 0.0 to 1.0	1.03 hr Interval 1.0 to 1.05	0.992 hr Interval 0.5 to 1.02

SECONDARY outcome

Timeframe: C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12)

Population: All 22 participants treated in the dose escalation stage were included in the analysis. n=number of evaluable participants at the specified time point.

Plasma docetaxel PK parameters were calculated following a 1-hr infusion of docetaxel given alone (Cycle 1 Day 1) and in combination with BID dosing of PF-03084014 (Cycle 2 Day 1)

Outcome measures

Measure	PF-03084014 100 mg BID + Docetaxel 75 mg/m^2 n=8 Participants PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\^2) intravenously.	PF-03084014 100 mg BID + Docetaxel 100 mg/m^2 n=3 Participants PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 100 mg/square meters (m\^2) intravenously.	PF-03084014 150 mg BID + Docetaxel 75 mg/m^2 n=11 Participants PF-03084014 150 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\^2) intravenously.
Tmax of Docetaxel in Dose-finding Cohort Tmax, C1D1	1.00 hr Interval 0.5 to 1.05	0.917 hr Interval 0.5 to 1.0	0.983 hr Interval 0.5 to 1.05
Tmax of Docetaxel in Dose-finding Cohort Tmax, C2D1	1.00 hr Interval 0.517 to 1.03	0.767 hr Interval 0.533 to 1.0	1.00 hr Interval 0.5 to 1.5

SECONDARY outcome

Timeframe: C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12)

Population: All 22 participants treated in the dose escalation stage were included in the analysis. n=number of evaluable participants at the specified time point.

Plasma docetaxel PK parameters were calculated following a 1-hr infusion of docetaxel given alone (Cycle 1 Day 1) and in combination with BID dosing of PF-03084014 (Cycle 2 Day 1)

Outcome measures

Measure	PF-03084014 100 mg BID + Docetaxel 75 mg/m^2 n=8 Participants PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\^2) intravenously.	PF-03084014 100 mg BID + Docetaxel 100 mg/m^2 n=3 Participants PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 100 mg/square meters (m\^2) intravenously.	PF-03084014 150 mg BID + Docetaxel 75 mg/m^2 n=11 Participants PF-03084014 150 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\^2) intravenously.
Systemic Clearance (CL) of Docetaxel in Dose-finding Cohort CL, C1D1	NA liter (L)/hr Geometric Coefficient of Variation NA There were only 2 participants with reportable CL at this time point and summary statistics are not calculated for \<3 participants. Individual values were 5.59 and 41.8 L/hr.	NA liter (L)/hr Geometric Coefficient of Variation NA There were only 2 participants with reportable CL at this time point and summary statistics are not calculated for \<3 participants. Individual values were 55.3 and 40.5 L/hr.	55.51 liter (L)/hr Geometric Coefficient of Variation 70
Systemic Clearance (CL) of Docetaxel in Dose-finding Cohort CL, C2D1	51.97 liter (L)/hr Geometric Coefficient of Variation 23	NA liter (L)/hr Geometric Coefficient of Variation NA There was only 1 participant with reportable CL at this time point and summary statistics are not calculated for \<3 participants. Individual value was 68.1 L/hr.	45.40 liter (L)/hr Geometric Coefficient of Variation 5

SECONDARY outcome

Timeframe: C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12)

Population: All 22 participants treated in the dose escalation stage were included in the analysis. n=number of evaluable participants at the specified time point.

Plasma docetaxel PK parameters were calculated following a 1-hr infusion of docetaxel given alone (Cycle 1 Day 1) and in combination with BID dosing of PF-03084014 (Cycle 2 Day 1)

Outcome measures

Measure	PF-03084014 100 mg BID + Docetaxel 75 mg/m^2 n=8 Participants PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\^2) intravenously.	PF-03084014 100 mg BID + Docetaxel 100 mg/m^2 n=3 Participants PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 100 mg/square meters (m\^2) intravenously.	PF-03084014 150 mg BID + Docetaxel 75 mg/m^2 n=11 Participants PF-03084014 150 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\^2) intravenously.
Terminal Half-life (t1/2) of Docetaxel in Dose-finding Cohort t1/2, C1D1	18.35 hr Standard Deviation NA There were only 2 participants with reportable t1/2 at this time point so standard deviation is not calculated for. Individual values were 20.8 and 15.9 hrs.	6.555 hr Standard Deviation NA There were only 2 participants with reportable t1/2 at this time point so standard deviation is not calculated for. Individual values were 10.1 and 3.01 hrs.	7.624 hr Standard Deviation 5.368
Terminal Half-life (t1/2) of Docetaxel in Dose-finding Cohort t1/2, C2D1	5.500 hr Standard Deviation 7.259	NA hr Standard Deviation NA There was only 1 participant with reportable t1/2 at this time point and summary statistics are not calculated for \<3 participants. Individual value was 3.84 hr.	14.27 hr Standard Deviation 3.420

SECONDARY outcome

Timeframe: C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12)

Population: All 22 participants treated in the dose escalation stage were included in the analysis. n=number of evaluable participants at the specified time point.

Plasma docetaxel PK parameters were calculated following a 1-hr infusion of docetaxel given alone (Cycle 1 Day 1) and in combination with BID dosing of PF-03084014 (Cycle 2 Day 1)

Outcome measures

Measure	PF-03084014 100 mg BID + Docetaxel 75 mg/m^2 n=8 Participants PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\^2) intravenously.	PF-03084014 100 mg BID + Docetaxel 100 mg/m^2 n=3 Participants PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 100 mg/square meters (m\^2) intravenously.	PF-03084014 150 mg BID + Docetaxel 75 mg/m^2 n=11 Participants PF-03084014 150 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\^2) intravenously.
Volume of Distribution (Vss) of Docetaxel in Dose-finding Cohort Vss, C1D1	NA L Geometric Coefficient of Variation NA There were only 2 participants with reportable Vss at this time point and summary statistics are not calculated for \<3 participants. Individual values were 5.54 and 288 L.	NA L Geometric Coefficient of Variation NA There were only 2 participants with reportable Vss at this time point and summary statistics are not calculated for \<3 participants. Individual values were 301 and 27.8 L.	97.34 L Geometric Coefficient of Variation 73
Volume of Distribution (Vss) of Docetaxel in Dose-finding Cohort Vss, C2D1	57.37 L Geometric Coefficient of Variation 127	NA L Geometric Coefficient of Variation NA There was only 1 participant with reportable Vss at this time point and summary statistics are not calculated for \<3 participants. Individual value was 85.4 L.	231.5 L Geometric Coefficient of Variation 25

SECONDARY outcome

Timeframe: C1D1, C1D21, and Day 1 of subsequent cycles and at EOT (max reached: C12)

Population: All 7 participants who received treatment in the expansion cohort were included in the analysis. n=number of evaluable participants at the specified time point.

Outcome measures

Measure	PF-03084014 100 mg BID + Docetaxel 75 mg/m^2 n=7 Participants PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\^2) intravenously.	PF-03084014 100 mg BID + Docetaxel 100 mg/m^2 PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 100 mg/square meters (m\^2) intravenously.	PF-03084014 150 mg BID + Docetaxel 75 mg/m^2 PF-03084014 150 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\^2) intravenously.
AUClast of PF-03084014 in the Expansion Cohort AUClast, C1D1	1098 ng*hr/mL Geometric Coefficient of Variation 47	—	—
AUClast of PF-03084014 in the Expansion Cohort AUClast, C1D21	1955 ng*hr/mL Geometric Coefficient of Variation 16	—	—

SECONDARY outcome

Timeframe: C1D1, C1D21, and Day 1 of subsequent cycles and at EOT (max reached: C12)

Population: All 7 participants who received treatment in the expansion cohort were included in the analysis. n=number of evaluable participants at the specified time point.

Outcome measures

Measure	PF-03084014 100 mg BID + Docetaxel 75 mg/m^2 n=7 Participants PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\^2) intravenously.	PF-03084014 100 mg BID + Docetaxel 100 mg/m^2 PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 100 mg/square meters (m\^2) intravenously.	PF-03084014 150 mg BID + Docetaxel 75 mg/m^2 PF-03084014 150 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\^2) intravenously.
Cmax of PF-03084014 in the Expansion Cohort Cmax, C1D1	496.7 ng/mL Geometric Coefficient of Variation 70	—	—
Cmax of PF-03084014 in the Expansion Cohort Cmax, C1D21	982.1 ng/mL Geometric Coefficient of Variation 20	—	—

SECONDARY outcome

Timeframe: C1D1, C1D21, and Day 1 of subsequent cycles and at EOT (max reached: C12)

Population: All 7 participants who received treatment in the expansion cohort were included in the analysis. n=number of evaluable participants at the specified time point.

Outcome measures

Measure	PF-03084014 100 mg BID + Docetaxel 75 mg/m^2 n=7 Participants PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\^2) intravenously.	PF-03084014 100 mg BID + Docetaxel 100 mg/m^2 PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 100 mg/square meters (m\^2) intravenously.	PF-03084014 150 mg BID + Docetaxel 75 mg/m^2 PF-03084014 150 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\^2) intravenously.
Tmax of PF-03084014 in the Expansion Cohort Tmax, C1D1	0.983 hr Interval 0.5 to 1.0	—	—
Tmax of PF-03084014 in the Expansion Cohort Tmax, C1D21	1.00 hr Interval 0.483 to 1.0	—	—

SECONDARY outcome

Timeframe: C1D1, C1D21, and Day 1 of subsequent cycles and at EOT (max reached: C12)

Population: All 7 participants who received treatment in the expansion cohort were included in the analysis. At Cycle 1 Day 21, only 5 participants had available data for Ctrough.

Outcome measures

Measure	PF-03084014 100 mg BID + Docetaxel 75 mg/m^2 n=5 Participants PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\^2) intravenously.	PF-03084014 100 mg BID + Docetaxel 100 mg/m^2 PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 100 mg/square meters (m\^2) intravenously.	PF-03084014 150 mg BID + Docetaxel 75 mg/m^2 PF-03084014 150 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\^2) intravenously.
Ctrough of PF-03084014 in the Expansion Cohort	89.22 ng/mL Geometric Coefficient of Variation 51 • Interval 0.5 to 1.0	—	—

SECONDARY outcome

Timeframe: Baseline up to 28-35 days after treatment discontinuation (up to Day 280)

Population: Only 4 participants had CR or PR, 2 each in the PF-03084014 100 mg BID + docetaxel 75 mg/m\^2 and PF-03084014 150 mg BID + docetaxel 75 mg/m\^2 groups.

Duration of response (DR) defined as time from start of first documented objective tumor response [Complete Response (CR) or Partial Response (PR)] to first documented objective tumor progression or death due to any cause, whichever occurs first. DR = (the end date for DR minus first subsequent confirmed CR or PR plus 1) divided by 7.02. CR: disappearance of all target lesions. PR: at least 30% decrease in the sum of diameters of target lesions.

Outcome measures

Measure	PF-03084014 100 mg BID + Docetaxel 75 mg/m^2 n=2 Participants PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\^2) intravenously.	PF-03084014 100 mg BID + Docetaxel 100 mg/m^2 n=2 Participants PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 100 mg/square meters (m\^2) intravenously.	PF-03084014 150 mg BID + Docetaxel 75 mg/m^2 PF-03084014 150 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\^2) intravenously.
Duration of Response (DR)	NA months Summary statistics not provided as there were 2 participants with PR/CR. Individual DRs were 2.79 and 5.55 months.	NA months Summary statistics not provided as there were 2 participants with PR/CR. Individual DRs were 3.19 and 4.20 months.	—

SECONDARY outcome

Timeframe: Screening, C1D1, C1D21, Day 1 of subsequent cycles, and EOT (maximum reached: C12)

Population: All 29 participants who received study treatment were analyzed for safety.

Criteria for categorical summarization of the time corresponding to the beginning of depolarization to repolarization of the ventricles (QT) corrected for heart rate (QTc) using Bazett's correction (QTcB) or Fridericia's correction (QTcF) included: maximum QTcB or QTcF less than or equal to (<=) 450 milliseconds (msec), 450 to <=480 msec, 480 to <=500 msec, more than (>) 500 msec; maximum QTcB or QTcF changes (increases/decreases) from baseline (BL) less than (<) 30 msec, 30 to <60 msec, more than or equal to (>=) 60 msec.

Outcome measures

Measure	PF-03084014 100 mg BID + Docetaxel 75 mg/m^2 n=15 Participants PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\^2) intravenously.	PF-03084014 100 mg BID + Docetaxel 100 mg/m^2 n=3 Participants PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 100 mg/square meters (m\^2) intravenously.	PF-03084014 150 mg BID + Docetaxel 75 mg/m^2 n=11 Participants PF-03084014 150 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\^2) intravenously.
Number of Participants With QTc Values Meeting Categorical Summarization Criteria QTcB <=450 msec	7 participants	1 participants	2 participants
Number of Participants With QTc Values Meeting Categorical Summarization Criteria QTcB 450 to <=480 msec	6 participants	1 participants	8 participants
Number of Participants With QTc Values Meeting Categorical Summarization Criteria QTcB 480 to <=500 msec	2 participants	1 participants	1 participants
Number of Participants With QTc Values Meeting Categorical Summarization Criteria QTcB >500 msec	0 participants	0 participants	0 participants
Number of Participants With QTc Values Meeting Categorical Summarization Criteria QTcF <=450 msec	13 participants	2 participants	6 participants
Number of Participants With QTc Values Meeting Categorical Summarization Criteria QTcF 450 to <=480 msec	1 participants	0 participants	5 participants
Number of Participants With QTc Values Meeting Categorical Summarization Criteria QTcF 480 to <=500 msec	1 participants	1 participants	0 participants
Number of Participants With QTc Values Meeting Categorical Summarization Criteria QTcF >500 msec	0 participants	0 participants	0 participants
Number of Participants With QTc Values Meeting Categorical Summarization Criteria QTcB increase from BL <30 msec	11 participants	3 participants	6 participants
Number of Participants With QTc Values Meeting Categorical Summarization Criteria QTcB increase from BL 30-<60 msec	4 participants	0 participants	5 participants
Number of Participants With QTc Values Meeting Categorical Summarization Criteria QTcB increase from BL >=60 msec	0 participants	0 participants	0 participants
Number of Participants With QTc Values Meeting Categorical Summarization Criteria QTcF increase from BL <30 msec	14 participants	3 participants	9 participants
Number of Participants With QTc Values Meeting Categorical Summarization Criteria QTcF increase from BL 30-<60 msec	1 participants	0 participants	2 participants
Number of Participants With QTc Values Meeting Categorical Summarization Criteria QTcF increase from BL >=60 msec	0 participants	0 participants	0 participants
Number of Participants With QTc Values Meeting Categorical Summarization Criteria QTcB decrease from BL <30 msec	15 participants	3 participants	11 participants
Number of Participants With QTc Values Meeting Categorical Summarization Criteria QTcB decrease from BL 30-<60 msec	0 participants	0 participants	0 participants
Number of Participants With QTc Values Meeting Categorical Summarization Criteria QTcB decrease from BL >=60msec	0 participants	0 participants	0 participants
Number of Participants With QTc Values Meeting Categorical Summarization Criteria QTcF decrease from BL <30 msec	13 participants	3 participants	8 participants
Number of Participants With QTc Values Meeting Categorical Summarization Criteria QTcF decrease from BL 30-<60 msec	2 participants	0 participants	3 participants
Number of Participants With QTc Values Meeting Categorical Summarization Criteria QTcF decrease from BL >=60 msec	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: C1D1, C1D2, C1D8, C1D21 and EOT (maximum reached: C12)

Population: All treated participants who had at least 1 screening and post treatment biomarker assessment. n=number of evaluable participants for the specified biomarker at the specified time point.

As PF-03084014 acts on the Notch pathway as an inhibitor, it is of interest to investigate its effects, if any, on the Notch family of receptors, mainly Notch 1-4.

Outcome measures

Measure	PF-03084014 100 mg BID + Docetaxel 75 mg/m^2 n=7 Participants PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\^2) intravenously.	PF-03084014 100 mg BID + Docetaxel 100 mg/m^2 n=2 Participants PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 100 mg/square meters (m\^2) intravenously.	PF-03084014 150 mg BID + Docetaxel 75 mg/m^2 n=10 Participants PF-03084014 150 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\^2) intravenously.
Percentage Change From Baseline in Notch 1 to 4 Ribonucleic Acid (RNA) in Blood Notch 1 RNA, C1D1	4.240 percentage change Standard Deviation 0.5164	3.990 percentage change Standard Deviation 0.4581	4.431 percentage change Standard Deviation 1.1781
Percentage Change From Baseline in Notch 1 to 4 Ribonucleic Acid (RNA) in Blood Notch 1 RNA, C1D2	-5.797 percentage change Standard Deviation 11.0169	-7.358 percentage change Standard Deviation 14.6569	-10.647 percentage change Standard Deviation 19.1488
Percentage Change From Baseline in Notch 1 to 4 Ribonucleic Acid (RNA) in Blood Notch 1 RNA, C1D8	32.557 percentage change Standard Deviation 22.0342	60.199 percentage change Standard Deviation NA Only 1 participant was evaluable at this time point.	35.305 percentage change Standard Deviation 19.4523
Percentage Change From Baseline in Notch 1 to 4 Ribonucleic Acid (RNA) in Blood Notch 1 RNA, C1D21	6.118 percentage change Standard Deviation 17.0382	17.047 percentage change Standard Deviation 15.6705	11.214 percentage change Standard Deviation 7.9496
Percentage Change From Baseline in Notch 1 to 4 Ribonucleic Acid (RNA) in Blood Notch 1 RNA, EOT	5.653 percentage change Standard Deviation 12.0722	18.066 percentage change Standard Deviation 9.4153	4.177 percentage change Standard Deviation 14.6678
Percentage Change From Baseline in Notch 1 to 4 Ribonucleic Acid (RNA) in Blood Notch 2 RNA, C1D1	4.139 percentage change Standard Deviation 0.4344	3.856 percentage change Standard Deviation 0.8869	4.351 percentage change Standard Deviation 0.7672
Percentage Change From Baseline in Notch 1 to 4 Ribonucleic Acid (RNA) in Blood Notch 2 RNA, C1D2	-12.830 percentage change Standard Deviation 8.1864	-9.617 percentage change Standard Deviation 16.7632	-15.441 percentage change Standard Deviation 20.3566
Percentage Change From Baseline in Notch 1 to 4 Ribonucleic Acid (RNA) in Blood Notch 2 RNA, C1D8	15.426 percentage change Standard Deviation 22.0876	43.069 percentage change Standard Deviation NA Only 1 participant was evaluable at this time point.	17.234 percentage change Standard Deviation 18.0896
Percentage Change From Baseline in Notch 1 to 4 Ribonucleic Acid (RNA) in Blood Notch 2 RNA, C1D21	2.161 percentage change Standard Deviation 9.7434	9.756 percentage change Standard Deviation 22.6330	4.985 percentage change Standard Deviation 7.6829
Percentage Change From Baseline in Notch 1 to 4 Ribonucleic Acid (RNA) in Blood Notch 2 RNA, EOT	-1.250 percentage change Standard Deviation 11.6223	9.478 percentage change Standard Deviation 28.0500	-1.558 percentage change Standard Deviation 10.9137
Percentage Change From Baseline in Notch 1 to 4 Ribonucleic Acid (RNA) in Blood Notch 3 RNA, C1D1	14.250 percentage change Standard Deviation NA Only 1 participant was evaluable at this time point.	14.673 percentage change Standard Deviation NA Only 1 participant was evaluable at this time point.	14.765 percentage change Standard Deviation 1.3469
Percentage Change From Baseline in Notch 1 to 4 Ribonucleic Acid (RNA) in Blood Notch 3 RNA, C1D2	—	0.311 percentage change Standard Deviation NA Only 1 participant was evaluable at this time point.	-1.186 percentage change Standard Deviation 2.9388
Percentage Change From Baseline in Notch 1 to 4 Ribonucleic Acid (RNA) in Blood Notch 3 RNA, C1D8	-2.532 percentage change Standard Deviation NA Only 1 participant was evaluable at this time point.	4.608 percentage change Standard Deviation NA Only 1 participant was evaluable at this time point.	-0.154 percentage change Standard Deviation 11.1968
Percentage Change From Baseline in Notch 1 to 4 Ribonucleic Acid (RNA) in Blood Notch 3 RNA, C1D21	—	1.362 percentage change Standard Deviation NA Only 1 participant was evaluable at this time point.	-11.274 percentage change Standard Deviation 19.4623
Percentage Change From Baseline in Notch 1 to 4 Ribonucleic Acid (RNA) in Blood Notch 4 RNA, C1D1	13.903 percentage change Standard Deviation 0.5575	13.228 percentage change Standard Deviation NA Only 1 participant was evaluable at this time point.	14.309 percentage change Standard Deviation 1.3340
Percentage Change From Baseline in Notch 1 to 4 Ribonucleic Acid (RNA) in Blood Notch 4 RNA, C1D2	—	12.215 percentage change Standard Deviation NA Only 1 participant was evaluable at this time point.	2.484 percentage change Standard Deviation 5.9621
Percentage Change From Baseline in Notch 1 to 4 Ribonucleic Acid (RNA) in Blood Notch 4 RNA, C1D8	-13.264 percentage change Standard Deviation 3.5374	—	-9.427 percentage change Standard Deviation 9.8077
Percentage Change From Baseline in Notch 1 to 4 Ribonucleic Acid (RNA) in Blood Notch 4 RNA, C1D21	0.927 percentage change Standard Deviation NA Only 1 participant was evaluable at this time point.	5.616 percentage change Standard Deviation NA Only 1 participant was evaluable at this time point.	-0.500 percentage change Standard Deviation 6.4382
Percentage Change From Baseline in Notch 1 to 4 Ribonucleic Acid (RNA) in Blood Notch 4 RNA, EOT	-3.634 percentage change Standard Deviation 9.0629	11.821 percentage change Standard Deviation NA Only 1 participant was evaluable at this time point.	-9.975 percentage change Standard Deviation 9.8833

Adverse Events

PF-03084014 100 mg BID + Docetaxel 75 mg/m^2

Serious events: 4 serious events

Other events: 15 other events

Deaths: 0 deaths

PF-03084014 100 mg BID + Docetaxel 100 mg/m^2

Serious events: 3 serious events

Other events: 3 other events

Deaths: 0 deaths

PF-03084014 150 mg BID + Docetaxel 75 mg/m^2

Serious events: 6 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Measure	PF-03084014 100 mg BID + Docetaxel 75 mg/m^2 n=15 participants at risk PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\^2) intravenously.	PF-03084014 100 mg BID + Docetaxel 100 mg/m^2 n=3 participants at risk PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 100 mg/square meters (m\^2) intravenously.	PF-03084014 150 mg BID + Docetaxel 75 mg/m^2 n=11 participants at risk PF-03084014 150 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\^2) intravenously.
Blood and lymphatic system disorders Febrile neutropenia	20.0% 3/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	27.3% 3/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Leukopenia	0.00% 0/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Neutropenia	0.00% 0/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Colitis	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Diarrhoea	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Vomiting	0.00% 0/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
General disorders Disease progression	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Localised infection	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Mastitis	0.00% 0/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Pneumonia	0.00% 0/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	18.2% 2/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Sepsis	0.00% 0/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Septic shock	0.00% 0/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Dehydration	0.00% 0/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.

Other adverse events

Measure	PF-03084014 100 mg BID + Docetaxel 75 mg/m^2 n=15 participants at risk PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\^2) intravenously.	PF-03084014 100 mg BID + Docetaxel 100 mg/m^2 n=3 participants at risk PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 100 mg/square meters (m\^2) intravenously.	PF-03084014 150 mg BID + Docetaxel 75 mg/m^2 n=11 participants at risk PF-03084014 150 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\^2) intravenously.
Blood and lymphatic system disorders Anaemia	66.7% 10/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	45.5% 5/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Febrile neutropenia	20.0% 3/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Leukopenia	66.7% 10/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	66.7% 2/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	45.5% 5/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Neutropenia	80.0% 12/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	100.0% 3/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	72.7% 8/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Thrombocytopenia	26.7% 4/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	66.7% 2/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	18.2% 2/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Cardiac disorders Sinus bradycardia	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Cardiac disorders Tachycardia	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Ear and labyrinth disorders Deafness	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Ear and labyrinth disorders Ear disorder	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Ear and labyrinth disorders Vertigo	0.00% 0/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Eye disorders Diplopia	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Eye disorders Eye irritation	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Eye disorders Periorbital oedema	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Eye disorders Visual impairment	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal discomfort	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain upper	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	18.2% 2/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Constipation	40.0% 6/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	45.5% 5/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Diarrhoea	66.7% 10/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	66.7% 2/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	72.7% 8/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Dry mouth	0.00% 0/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	18.2% 2/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Dyspepsia	13.3% 2/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Dysphagia	0.00% 0/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Flatulence	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Gastrooesophageal reflux disease	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Hemorrhoids	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Intestinal obstruction	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Nausea	73.3% 11/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	100.0% 3/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	72.7% 8/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Oedema mouth	0.00% 0/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Oral pain	0.00% 0/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	18.2% 2/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Proctalgia	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Stomatitis	13.3% 2/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	36.4% 4/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Vomiting	33.3% 5/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	81.8% 9/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
General disorders Asthenia	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
General disorders Chest pain	13.3% 2/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
General disorders Face oedema	0.00% 0/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
General disorders Fatigue	80.0% 12/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	66.7% 2/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	100.0% 11/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
General disorders Influenza like illness	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	18.2% 2/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
General disorders Local swelling	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
General disorders Mucosal inflammation	60.0% 9/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	66.7% 2/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	27.3% 3/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
General disorders Oedema peripheral	20.0% 3/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
General disorders Pain	0.00% 0/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
General disorders Performance status decreased	0.00% 0/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
General disorders Pyrexia	26.7% 4/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	100.0% 3/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	36.4% 4/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
General disorders Vessel puncture site bruise	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Immune system disorders Hypersensitivity	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Candida infection	13.3% 2/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Clostridium difficile colitis	0.00% 0/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Conjunctivitis	0.00% 0/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Escherichia urinary tract infection	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Folliculitis	0.00% 0/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Herpes simplex	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Influenza	0.00% 0/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Lung infection	13.3% 2/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Oral candidiasis	0.00% 0/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	18.2% 2/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Oral herpes	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Pharyngitis	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	27.3% 3/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Pneumonia	0.00% 0/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	18.2% 2/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Pulpitis dental	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Sepsis	0.00% 0/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Skin infection	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Urinary tract infection	13.3% 2/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Urinary tract infection enterococcal	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Vaginal infection	13.3% 2/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Vulvovaginal candidiasis	0.00% 0/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Fall	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Incision site erythema	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Thermal burn	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Investigations Activated partial thromboplastin time prolonged	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Investigations Alanine aminotransferase increased	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Investigations Aspartate aminotransferase increased	13.3% 2/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Investigations Blood alkaline phosphatase increased	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Investigations Blood creatinine increased	0.00% 0/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Investigations Blood glucose increased	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Investigations Blood magnesium decreased	0.00% 0/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Investigations Blood potassium decreased	0.00% 0/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Investigations Body temperature increased	0.00% 0/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Investigations Eosinophil count decreased	0.00% 0/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Investigations International normalized ratio increased	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Investigations Lymphocyte count decreased	0.00% 0/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Investigations Monocyte count decreased	0.00% 0/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Investigations Neutrophil count decreased	13.3% 2/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Investigations Platelet count decreased	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Investigations Prothrombin time prolonged	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Investigations Transaminases increased	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Investigations Weight decreased	0.00% 0/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Investigations Weight increased	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Investigations White blood cell count decreased	13.3% 2/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Cachexia	0.00% 0/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Decreased appetite	13.3% 2/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	27.3% 3/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Dehydration	0.00% 0/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Fluid retention	0.00% 0/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypercalcaemia	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hyperglycaemia	33.3% 5/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypoalbuminaemia	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypocalcaemia	26.7% 4/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypokalaemia	20.0% 3/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	66.7% 2/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	18.2% 2/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypomagnesaemia	13.3% 2/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hyponatraemia	20.0% 3/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypophosphataemia	46.7% 7/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	66.7% 2/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	27.3% 3/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Vitamin K deficiency	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Arthralgia	13.3% 2/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	27.3% 3/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Bone pain	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Muscle spasms	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Muscle twitching	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Myalgia	13.3% 2/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Pain in extremity	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	18.2% 2/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Spinal pain	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	13.3% 2/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Dizziness	13.3% 2/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Dysgeusia	13.3% 2/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Headache	26.7% 4/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	66.7% 2/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	54.5% 6/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Neuropathy peripheral	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Peripheral sensory neuropathy	20.0% 3/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Seizure	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Visual field defect	0.00% 0/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Anxiety	0.00% 0/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Insomnia	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	18.2% 2/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Acute kidney injury	0.00% 0/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Proteinuria	26.7% 4/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	18.2% 2/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Reproductive system and breast disorders Breast inflammation	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Reproductive system and breast disorders Breast pain	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Reproductive system and breast disorders Vaginal inflammation	0.00% 0/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Reproductive system and breast disorders Vulvovaginal rash	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Cough	20.0% 3/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	36.4% 4/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	26.7% 4/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Epistaxis	13.3% 2/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	18.2% 2/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Laryngeal pain	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Nasal dryness	0.00% 0/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Paranasal sinus discomfort	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Productive cough	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Acne	0.00% 0/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	18.2% 2/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Alopecia	53.3% 8/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	66.7% 2/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	54.5% 6/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Dermatitis acneiform	13.3% 2/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Dry skin	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Erythema	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Hyperkeratosis	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Nail discolouration	0.00% 0/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Nail disorder	26.7% 4/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Onycholysis	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Onychomadesis	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Papule	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Pruritus	20.0% 3/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Rash	20.0% 3/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	100.0% 3/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	54.5% 6/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Rash erythematosus	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Rash maculo-papular	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Skin discolouration	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Urticaria	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Vascular disorders Deep vein thrombosis	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Vascular disorders Hot flush	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Vascular disorders Hypotension	0.00% 0/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.
Vascular disorders Lymphoedema	6.7% 1/15 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 • Baseline up to 28-35 days after treatment discontinuation (up to Day 280) All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc

Phone: 18007181021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

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