Trial Outcomes & Findings for Study Of Dacomitinib (PF-00299804) In Advanced NSCLC Patients (Post Chemo Or Select First Line) To Evaluate Prophylactic Intervention On Derm And GI AEs And PRO (NCT NCT01465802)

NCT ID: NCT01465802

Last Updated: 2019-01-09

Results Overview

SDAEI of all causality and all grades were evaluated in participants in Cohort I. These SDAEIs included dermatitis acneiform, dry skin, exfoliative rash, nail discoloration, nail disorder, paronychia, pruritus, rash, skin exfoliation, skin fissures, skin infection, skin laceration and skin ulcer. 95% confidence interval (CI) calculated using exact method based on binomial distribution. After protocol amendment 1, Arm C was removed from Cohort I and enrollment to Arm C was terminated. Only 7 participants were enrolled in Cohort I Arm C as a result. Given the smaller sample size, analyse of Outcome Measure 1 was not conducted in Cohort I Arm C.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 236 participants
• Primary outcome timeframe: First 8 Weeks of Treatment
• Results posted on: 2019-01-09

Participant Flow

Participant milestones

Measure	Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo) Open-label dacomitinib 45 milligram (mg) tablets orally (PO) taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).	Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg) Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).	Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate) Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05 percent (%) applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).	Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone) Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks \[range of 32 to 35 days\]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).	Cohort III (Dacomitinib 45 mg) Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
Overall Study STARTED	66	66	7	67	25
Overall Study COMPLETED	33	42	7	38	13
Overall Study NOT COMPLETED	33	24	0	29	12

Reasons for withdrawal

Measure	Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo) Open-label dacomitinib 45 milligram (mg) tablets orally (PO) taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).	Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg) Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).	Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate) Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05 percent (%) applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).	Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone) Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks \[range of 32 to 35 days\]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).	Cohort III (Dacomitinib 45 mg) Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
Overall Study Study terminated by sponsor	1	0	0	1	7
Overall Study Withdrawal by Subject	7	7	0	8	1
Overall Study Lost to Follow-up	1	1	0	0	0
Overall Study Reason not specified	9	4	0	10	2
Overall Study Death	15	12	0	10	2

Baseline Characteristics

Study Of Dacomitinib (PF-00299804) In Advanced NSCLC Patients (Post Chemo Or Select First Line) To Evaluate Prophylactic Intervention On Derm And GI AEs And PRO

Baseline characteristics by cohort

Measure	Total n=231 Participants Total of all reporting groups	Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo) n=66 Participants Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).	Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg) n=66 Participants Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).	Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate) n=7 Participants Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).	Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone) n=67 Participants Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks \[range of 32 to 35 days\]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).	Cohort III (Dacomitinib 45 mg) n=25 Participants Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
Age, Continuous	64.9 Years STANDARD_DEVIATION 10.59 • n=8 Participants	65.0 Years STANDARD_DEVIATION 10.38 • n=5 Participants	64.4 Years STANDARD_DEVIATION 10.55 • n=7 Participants	61.3 Years STANDARD_DEVIATION 7.67 • n=5 Participants	66.0 Years STANDARD_DEVIATION 9.63 • n=4 Participants	64.2 Years STANDARD_DEVIATION 14.29 • n=21 Participants
Sex: Female, Male Female	109 Participants n=8 Participants	38 Participants n=5 Participants	27 Participants n=7 Participants	2 Participants n=5 Participants	24 Participants n=4 Participants	18 Participants n=21 Participants
Sex: Female, Male Male	122 Participants n=8 Participants	28 Participants n=5 Participants	39 Participants n=7 Participants	5 Participants n=5 Participants	43 Participants n=4 Participants	7 Participants n=21 Participants

PRIMARY outcome

Timeframe: First 8 Weeks of Treatment

Population: Evaluable Population - included all participants who received the study treatment assigned at enrollment, but did not discontinue dacomitinib treatment less than 6 weeks from first dosing due to either disease progression or death.

SDAEI of all causality and all grades were evaluated in participants in Cohort I. These SDAEIs included dermatitis acneiform, dry skin, exfoliative rash, nail discoloration, nail disorder, paronychia, pruritus, rash, skin exfoliation, skin fissures, skin infection, skin laceration and skin ulcer.

95% confidence interval (CI) calculated using exact method based on binomial distribution.

After protocol amendment 1, Arm C was removed from Cohort I and enrollment to Arm C was terminated. Only 7 participants were enrolled in Cohort I Arm C as a result. Given the smaller sample size, analyse of Outcome Measure 1 was not conducted in Cohort I Arm C.

Outcome measures

Measure	Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo) n=58 Participants Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).	Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg) n=56 Participants Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).	Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate) Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).	Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone) Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks \[range of 32 to 35 days\]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).	Cohort III (Dacomitinib 45 mg) Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
Percentage of Participants With Select Dermatologic Adverse Events of Interest (SDAEI) (All Causality, All Grade) in the First 8 Weeks of Treatment by Treatment Arm for Cohort I	79.3 Percentage of Participants Interval 66.6 to 88.8	75.0 Percentage of Participants Interval 61.6 to 85.6	—	—	—

PRIMARY outcome

Timeframe: First 8 Weeks of Treatment

Population: Evaluable Population

SDAEI of all causality and Grade ≥2 were evaluated in participants in Cohort I. These SDAEIs included dermatitis acneiform, dry skin, exfoliative rash, nail discoloration, nail disorder, paronychia, pruritus, rash, skin exfoliation, skin fissures, skin infection, skin laceration and skin ulcer. Adverse events (AEs) were graded for severity using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, Version 4.0).

95% CI calculated using exact method based on binomial distribution. After protocol amendment 1, Arm C was removed from Cohort I and enrollment to Arm C was terminated. Only 7 participants were enrolled in Cohort I Arm C as a result. Given the smaller sample size, analyse of Outcome Measure 2 was not conducted in Cohort I Arm C.

Outcome measures

Measure	Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo) n=58 Participants Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).	Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg) n=56 Participants Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).	Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate) Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).	Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone) Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks \[range of 32 to 35 days\]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).	Cohort III (Dacomitinib 45 mg) Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
Percentage of Participants With SDAEI (All Causality, Grade Greater Than or Equal to [≥] 2) in the First 8 Weeks of Treatment by Treatment Arm for Cohort I	46.6 Percentage of Participants Interval 33.3 to 60.1	23.2 Percentage of Participants Interval 13.0 to 36.4	—	—	—

PRIMARY outcome

Timeframe: First 8 Weeks of Treatment

Population: PRO Skindex Analysis Population: participants that met primary endpoint analysis \& Skindex specific criteria: a) Skindex completion criteria (as above) for initial visit \& end of Cycle 2 or EoT visit; b) Skindex completion criteria for at least 5 of 6 visits between initial visit \& end of Cycle 2 visit. n = number of participants completing scale.

Patient Reported Outcomes (PROs) of Health Related Quality of Life (HRQoL) & disease/treatment-related symptoms were assessed using Dermatologic Survey (Skindex-16) that assesses "bother". It includes 3 multi-item scales: symptoms, emotions & functioning. Individual scaled scores & total scores were determined. Skindex questions were transformed to a linear scale of 0 (never bothered) to 100 (always bothered). Subscale scores are an average of non-missing questions in a given scale if greater than (>) 75% of total subscale questions are non-missing. The Total Score is an average of all non-missing questions in the Skindex if >75% of total questions are non-missing. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant.

Skindex completion criteria were defined as completion of 3 out of 4 items for questions 1 to 4, 6 out of 7 items for questions 5 to 11, 4 out of 5 items for questions 12 to 16 for the visit.

Outcome measures

Measure	Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo) n=42 Participants Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).	Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg) n=42 Participants Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).	Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate) n=4 Participants Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).	Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone) Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks \[range of 32 to 35 days\]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).	Cohort III (Dacomitinib 45 mg) Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) by Treatment Arm for Cohort I Symptoms: Cycle 2 Day 22 (n=35, 39, 4)	15.4 Score on a scale Standard Deviation 22.34	12.9 Score on a scale Standard Deviation 22.72	14.6 Score on a scale Standard Deviation 15.40	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) by Treatment Arm for Cohort I Symptoms: Cycle 1 Day 8 (n=41, 42, 4)	2.3 Score on a scale Standard Deviation 10.12	-1.1 Score on a scale Standard Deviation 10.91	9.4 Score on a scale Standard Deviation 14.18	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) by Treatment Arm for Cohort I Symptoms: Cycle 1 Day 15 (n=41, 42, 3)	21.4 Score on a scale Standard Deviation 30.98	5.0 Score on a scale Standard Deviation 19.82	30.6 Score on a scale Standard Deviation 42.56	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) by Treatment Arm for Cohort I Symptoms: Cycle 1 Day 22 (n=42, 40, 4)	18.0 Score on a scale Standard Deviation 25.76	6.8 Score on a scale Standard Deviation 20.45	32.3 Score on a scale Standard Deviation 25.54	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) by Treatment Arm for Cohort I Symptoms: Cycle 2 Day 1 (n=41, 42, 4)	14.7 Score on a scale Standard Deviation 23.74	6.3 Score on a scale Standard Deviation 15.38	14.6 Score on a scale Standard Deviation 18.48	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) by Treatment Arm for Cohort I Symptoms: Cycle 2 Day 8 (n=42, 39, 4)	17.8 Score on a scale Standard Deviation 26.78	9.8 Score on a scale Standard Deviation 20.00	13.5 Score on a scale Standard Deviation 19.36	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) by Treatment Arm for Cohort I Symptoms: Cycle 2 Day 15 (n=37, 40, 4)	16.6 Score on a scale Standard Deviation 21.10	9.2 Score on a scale Standard Deviation 19.54	19.8 Score on a scale Standard Deviation 28.74	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) by Treatment Arm for Cohort I Symptoms: EoT (n=7, 3, 0)	13.1 Score on a scale Standard Deviation 32.85	16.7 Score on a scale Standard Deviation 19.09	NA Score on a scale Standard Deviation NA NA = not applicable. The number of participants completing the scale at this timepoint was 0.	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) by Treatment Arm for Cohort I Emotion: Cycle 1 Day 8 (n=41, 42, 4)	3.7 Score on a scale Standard Deviation 21.08	-2.5 Score on a scale Standard Deviation 12.11	7.3 Score on a scale Standard Deviation 14.68	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) by Treatment Arm for Cohort I Emotion: Cycle 1 Day 15 (n=41, 42, 3)	20.7 Score on a scale Standard Deviation 28.51	2.9 Score on a scale Standard Deviation 17.14	29.8 Score on a scale Standard Deviation 45.03	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) by Treatment Arm for Cohort I Emotion: Cycle 1 Day 22 (n=42, 40, 4)	17.7 Score on a scale Standard Deviation 27.67	3.7 Score on a scale Standard Deviation 16.07	37.7 Score on a scale Standard Deviation 32.44	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) by Treatment Arm for Cohort I Emotion: Cycle 2 Day 1 (n=41, 42, 4)	15.6 Score on a scale Standard Deviation 25.15	6.5 Score on a scale Standard Deviation 15.25	23.4 Score on a scale Standard Deviation 30.15	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) by Treatment Arm for Cohort I Emotion: Cycle 2 Day 8 (n=42, 39, 4)	15.1 Score on a scale Standard Deviation 25.55	6.3 Score on a scale Standard Deviation 17.28	21.6 Score on a scale Standard Deviation 35.76	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) by Treatment Arm for Cohort I Emotion: Cycle 2 Day 15 (n=37, 40, 4)	13.0 Score on a scale Standard Deviation 22.70	8.4 Score on a scale Standard Deviation 20.20	21.0 Score on a scale Standard Deviation 40.49	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) by Treatment Arm for Cohort I Emotion: Cycle 2 Day 22 (n=35, 39, 4)	14.8 Score on a scale Standard Deviation 25.91	12.0 Score on a scale Standard Deviation 23.73	10.9 Score on a scale Standard Deviation 17.39	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) by Treatment Arm for Cohort I Emotion: EoT (n=7, 3, 0)	9.9 Score on a scale Standard Deviation 21.27	22.2 Score on a scale Standard Deviation 21.34	NA Score on a scale Standard Deviation NA The number of participants completing the scale at this timepoint was 0.	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) by Treatment Arm for Cohort I Functioning: Cycle 1 Day 8 (n=41, 42, 4)	3.1 Score on a scale Standard Deviation 17.60	-1.2 Score on a scale Standard Deviation 5.50	-0.8 Score on a scale Standard Deviation 1.67	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) by Treatment Arm for Cohort I Functioning: Cycle 1 Day 15 (n=41, 42, 3)	11.1 Score on a scale Standard Deviation 21.41	0.6 Score on a scale Standard Deviation 7.47	24.4 Score on a scale Standard Deviation 42.34	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) by Treatment Arm for Cohort I Functioning: Cycle 1 Day 22 (n=42, 40, 4)	11.7 Score on a scale Standard Deviation 21.68	1.9 Score on a scale Standard Deviation 8.86	33.3 Score on a scale Standard Deviation 31.39	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) by Treatment Arm for Cohort I Functioning: Cycle 2 Day 1 (n=41, 42, 4)	8.5 Score on a scale Standard Deviation 21.53	2.1 Score on a scale Standard Deviation 7.72	20.0 Score on a scale Standard Deviation 21.26	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) by Treatment Arm for Cohort I Functioning: Cycle 2 Day 8 (n=42, 39, 4)	7.0 Score on a scale Standard Deviation 18.51	2.4 Score on a scale Standard Deviation 9.52	12.5 Score on a scale Standard Deviation 20.79	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) by Treatment Arm for Cohort I Functioning: Cycle 2 Day 15 (n=37, 40, 4)	8.3 Score on a scale Standard Deviation 22.20	2.7 Score on a scale Standard Deviation 10.58	13.3 Score on a scale Standard Deviation 22.44	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) by Treatment Arm for Cohort I Functioning: Cycle 2 Day 22 (n=35, 39, 4)	7.8 Score on a scale Standard Deviation 22.32	5.4 Score on a scale Standard Deviation 13.78	14.2 Score on a scale Standard Deviation 20.44	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) by Treatment Arm for Cohort I Functioning: EoT (n=7, 3, 0)	8.6 Score on a scale Standard Deviation 11.84	14.4 Score on a scale Standard Deviation 25.02	NA Score on a scale Standard Deviation NA The number of participants completing the scale at this timepoint was 0.	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) by Treatment Arm for Cohort I Total: Cycle 1 Day 8 (n=41, 42, 4)	3.2 Score on a scale Standard Deviation 15.91	-1.7 Score on a scale Standard Deviation 8.07	5.3 Score on a scale Standard Deviation 9.36	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) by Treatment Arm for Cohort I Total: Cycle 1 Day 15 (n=41, 42, 3)	17.9 Score on a scale Standard Deviation 25.09	2.7 Score on a scale Standard Deviation 13.08	28.4 Score on a scale Standard Deviation 43.52	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) by Treatment Arm for Cohort I Total: Cycle 1 Day 22 (n=42, 40, 4)	15.9 Score on a scale Standard Deviation 23.39	4.0 Score on a scale Standard Deviation 13.33	35.0 Score on a scale Standard Deviation 29.97	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) by Treatment Arm for Cohort I Total: Cycle 2 Day 1 (n=41, 42, 4)	13.1 Score on a scale Standard Deviation 20.74	5.1 Score on a scale Standard Deviation 11.65	20.2 Score on a scale Standard Deviation 21.75	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) by Treatment Arm for Cohort I Total: Cycle 2 Day 8 (n=42, 39, 4)	13.2 Score on a scale Standard Deviation 21.17	6.0 Score on a scale Standard Deviation 13.49	16.8 Score on a scale Standard Deviation 24.54	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) by Treatment Arm for Cohort I Total: Cycle 2 Day 15 (n=37, 40, 4)	12.4 Score on a scale Standard Deviation 20.39	6.8 Score on a scale Standard Deviation 14.84	18.4 Score on a scale Standard Deviation 31.50	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) by Treatment Arm for Cohort I Total: Cycle 2 Day 22 (n=35, 39, 4)	12.7 Score on a scale Standard Deviation 21.24	10.1 Score on a scale Standard Deviation 18.36	12.9 Score on a scale Standard Deviation 17.22	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) by Treatment Arm for Cohort I Total: EoT (n=7, 3, 0)	10.3 Score on a scale Standard Deviation 18.79	18.4 Score on a scale Standard Deviation 18.64	NA Score on a scale Standard Deviation NA The number of participants completing the scale at this timepoint was 0.	—	—

PRIMARY outcome

Timeframe: First 8 Weeks of Treatment

Population: Evaluable Population

Diarrhea AEs of all causality, all grade and Grade ≥2 were evaluated in participants in Cohort II. AEs were graded for severity using the NCI-CTCAE, Version 4.0.

95% CI calculated using exact method based on binomial distribution.

Outcome measures

Measure	Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo) n=59 Participants Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).	Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg) Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).	Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate) Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).	Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone) Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks \[range of 32 to 35 days\]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).	Cohort III (Dacomitinib 45 mg) Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
Percentage of Participants With Diarrhea AEs (All Causality, All Grade and Grade ≥2) in the First 8 Weeks of Treatment for Cohort II All Causality, All Grade	83.1 Percentage of Participants Interval 71.0 to 91.6	—	—	—	—
Percentage of Participants With Diarrhea AEs (All Causality, All Grade and Grade ≥2) in the First 8 Weeks of Treatment for Cohort II All Causality, Grade ≥2	39.0 Percentage of Participants Interval 26.5 to 52.6	—	—	—	—

PRIMARY outcome

Timeframe: Cycles 1, 2, 3, 4, 5, and 6, EoT and Follow-up

Population: PRO Modified OMDQ Analysis Population; participants meeting primary endpoint analysis \& modified OMDQ specific criteria: a) Modified OMDQ completion criteria for initial visit \& end of Cycle 2 or EoT visit; b) Completion criteria for at least 5 of 6 visits between initial \& end of Cycle 2 visit. n = number of participants completing scale.

Diarrhea severity was assessed using the modified-OMDQ. This questionnaire is comprised of 6 questions in total; however, only two items relate to diarrhea symptoms (item 5 and item 6). Symptoms scores were developed for both the full questionnaire and for the diarrhea-only questions for each completed survey. Mucositis questions were transformed to a score range of 0 to 10. Increasing OMDQ values are associated with greater symptom burden.

Modified OMDQ completion criteria were defined as completion of all 4 questions (questions 2, 4, 5 and 6).

M/T = mouth and throat.

Outcome measures

Measure	Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo) n=37 Participants Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).	Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg) Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).	Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate) Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).	Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone) Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks \[range of 32 to 35 days\]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).	Cohort III (Dacomitinib 45 mg) Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
Mean Change From Baseline (Cycle 1 Day 1) Modified Oral Mucositis Daily Questionnaire (OMDQ) Scores (Mouth and Throat Soreness Categories and Scale, and Diarrhea Categories and Scale) for Cohort II M/T Soreness Categories: Cycle 1 Day 8 (n=37)	0.8 Score on a scale Standard Deviation 2.05	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Modified Oral Mucositis Daily Questionnaire (OMDQ) Scores (Mouth and Throat Soreness Categories and Scale, and Diarrhea Categories and Scale) for Cohort II M/T Soreness Categories: Cycle 1 Day 15 (n=37)	2.5 Score on a scale Standard Deviation 3.12	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Modified Oral Mucositis Daily Questionnaire (OMDQ) Scores (Mouth and Throat Soreness Categories and Scale, and Diarrhea Categories and Scale) for Cohort II M/T Soreness Categories: Cycle 1 Day 22 (n=37)	2.6 Score on a scale Standard Deviation 2.97	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Modified Oral Mucositis Daily Questionnaire (OMDQ) Scores (Mouth and Throat Soreness Categories and Scale, and Diarrhea Categories and Scale) for Cohort II M/T Soreness Categories: Cycle 2 Day 1 (n=37)	2.5 Score on a scale Standard Deviation 2.43	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Modified Oral Mucositis Daily Questionnaire (OMDQ) Scores (Mouth and Throat Soreness Categories and Scale, and Diarrhea Categories and Scale) for Cohort II M/T Soreness Categories: Cycle 2 Day 8 (n=35)	1.9 Score on a scale Standard Deviation 2.30	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Modified Oral Mucositis Daily Questionnaire (OMDQ) Scores (Mouth and Throat Soreness Categories and Scale, and Diarrhea Categories and Scale) for Cohort II M/T Soreness Categories: Cycle 2 Day 15 (n=36)	1.7 Score on a scale Standard Deviation 1.97	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Modified Oral Mucositis Daily Questionnaire (OMDQ) Scores (Mouth and Throat Soreness Categories and Scale, and Diarrhea Categories and Scale) for Cohort II M/T Soreness Categories: Cycle 2 Day 22 (n=27)	1.6 Score on a scale Standard Deviation 1.85	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Modified Oral Mucositis Daily Questionnaire (OMDQ) Scores (Mouth and Throat Soreness Categories and Scale, and Diarrhea Categories and Scale) for Cohort II M/T Soreness Categories: Cycle 3 Day 1 (n=19)	2.1 Score on a scale Standard Deviation 2.09	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Modified Oral Mucositis Daily Questionnaire (OMDQ) Scores (Mouth and Throat Soreness Categories and Scale, and Diarrhea Categories and Scale) for Cohort II M/T Soreness Categories: Cycle 4 Day 1 (n=13)	1.7 Score on a scale Standard Deviation 2.14	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Modified Oral Mucositis Daily Questionnaire (OMDQ) Scores (Mouth and Throat Soreness Categories and Scale, and Diarrhea Categories and Scale) for Cohort II M/T Soreness Categories: Cycle 5 Day 1 (n=10)	1.0 Score on a scale Standard Deviation 1.29	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Modified Oral Mucositis Daily Questionnaire (OMDQ) Scores (Mouth and Throat Soreness Categories and Scale, and Diarrhea Categories and Scale) for Cohort II M/T Soreness Categories: Cycle 6 Day 1 (n=8)	0.3 Score on a scale Standard Deviation 0.88	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Modified Oral Mucositis Daily Questionnaire (OMDQ) Scores (Mouth and Throat Soreness Categories and Scale, and Diarrhea Categories and Scale) for Cohort II M/T Soreness Categories: EoT (n=30)	1.4 Score on a scale Standard Deviation 2.34	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Modified Oral Mucositis Daily Questionnaire (OMDQ) Scores (Mouth and Throat Soreness Categories and Scale, and Diarrhea Categories and Scale) for Cohort II M/T Soreness Categories: Follow-up (n=22)	0.3 Score on a scale Standard Deviation 2.48	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Modified Oral Mucositis Daily Questionnaire (OMDQ) Scores (Mouth and Throat Soreness Categories and Scale, and Diarrhea Categories and Scale) for Cohort II M/T Soreness Scale: Cycle 1 Day 8 (n=37)	1.0 Score on a scale Standard Deviation 2.00	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Modified Oral Mucositis Daily Questionnaire (OMDQ) Scores (Mouth and Throat Soreness Categories and Scale, and Diarrhea Categories and Scale) for Cohort II M/T Soreness Scale: Cycle 1 Day 15 (n=37)	2.5 Score on a scale Standard Deviation 3.00	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Modified Oral Mucositis Daily Questionnaire (OMDQ) Scores (Mouth and Throat Soreness Categories and Scale, and Diarrhea Categories and Scale) for Cohort II M/T Soreness Scale: Cycle 1 Day 22 (n=37)	2.2 Score on a scale Standard Deviation 2.51	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Modified Oral Mucositis Daily Questionnaire (OMDQ) Scores (Mouth and Throat Soreness Categories and Scale, and Diarrhea Categories and Scale) for Cohort II M/T Soreness Scale: Cycle 2 Day 1 (n=37)	2.2 Score on a scale Standard Deviation 2.28	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Modified Oral Mucositis Daily Questionnaire (OMDQ) Scores (Mouth and Throat Soreness Categories and Scale, and Diarrhea Categories and Scale) for Cohort II M/T Soreness Scale: Cycle 2 Day 8 (n=35)	1.7 Score on a scale Standard Deviation 1.97	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Modified Oral Mucositis Daily Questionnaire (OMDQ) Scores (Mouth and Throat Soreness Categories and Scale, and Diarrhea Categories and Scale) for Cohort II M/T Soreness Scale: Cycle 2 Day 15 (n=36)	1.6 Score on a scale Standard Deviation 1.83	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Modified Oral Mucositis Daily Questionnaire (OMDQ) Scores (Mouth and Throat Soreness Categories and Scale, and Diarrhea Categories and Scale) for Cohort II M/T Soreness Scale: Cycle 2 Day 22 (n=27)	1.9 Score on a scale Standard Deviation 2.45	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Modified Oral Mucositis Daily Questionnaire (OMDQ) Scores (Mouth and Throat Soreness Categories and Scale, and Diarrhea Categories and Scale) for Cohort II M/T Soreness Scale: Cycle 3 Day 1 (n=19)	2.2 Score on a scale Standard Deviation 2.81	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Modified Oral Mucositis Daily Questionnaire (OMDQ) Scores (Mouth and Throat Soreness Categories and Scale, and Diarrhea Categories and Scale) for Cohort II M/T Soreness Scale: Cycle 4 Day 1 (n=13)	1.6 Score on a scale Standard Deviation 2.81	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Modified Oral Mucositis Daily Questionnaire (OMDQ) Scores (Mouth and Throat Soreness Categories and Scale, and Diarrhea Categories and Scale) for Cohort II M/T Soreness Scale: Cycle 5 Day 1 (n=10)	1.0 Score on a scale Standard Deviation 1.76	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Modified Oral Mucositis Daily Questionnaire (OMDQ) Scores (Mouth and Throat Soreness Categories and Scale, and Diarrhea Categories and Scale) for Cohort II M/T Soreness Scale: Cycle 6 Day 1 (n=8)	0.1 Score on a scale Standard Deviation 0.35	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Modified Oral Mucositis Daily Questionnaire (OMDQ) Scores (Mouth and Throat Soreness Categories and Scale, and Diarrhea Categories and Scale) for Cohort II M/T Soreness Scale: EoT (n=30)	1.3 Score on a scale Standard Deviation 1.78	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Modified Oral Mucositis Daily Questionnaire (OMDQ) Scores (Mouth and Throat Soreness Categories and Scale, and Diarrhea Categories and Scale) for Cohort II M/T Soreness Scale: Follow-up (n=22)	0.5 Score on a scale Standard Deviation 1.68	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Modified Oral Mucositis Daily Questionnaire (OMDQ) Scores (Mouth and Throat Soreness Categories and Scale, and Diarrhea Categories and Scale) for Cohort II Diarrhea Categories: Cycle 1 Day 8 (n=37)	2.1 Score on a scale Standard Deviation 2.67	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Modified Oral Mucositis Daily Questionnaire (OMDQ) Scores (Mouth and Throat Soreness Categories and Scale, and Diarrhea Categories and Scale) for Cohort II Diarrhea Categories: Cycle 1 Day 15 (n=37)	3.2 Score on a scale Standard Deviation 2.94	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Modified Oral Mucositis Daily Questionnaire (OMDQ) Scores (Mouth and Throat Soreness Categories and Scale, and Diarrhea Categories and Scale) for Cohort II Diarrhea Categories: Cycle 1 Day 22 (n=36)	3.9 Score on a scale Standard Deviation 3.19	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Modified Oral Mucositis Daily Questionnaire (OMDQ) Scores (Mouth and Throat Soreness Categories and Scale, and Diarrhea Categories and Scale) for Cohort II Diarrhea Categories: Cycle 2 Day 1 (n=37)	3.0 Score on a scale Standard Deviation 2.83	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Modified Oral Mucositis Daily Questionnaire (OMDQ) Scores (Mouth and Throat Soreness Categories and Scale, and Diarrhea Categories and Scale) for Cohort II Diarrhea Categories: Cycle 2 Day 8 (n=34)	2.2 Score on a scale Standard Deviation 3.00	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Modified Oral Mucositis Daily Questionnaire (OMDQ) Scores (Mouth and Throat Soreness Categories and Scale, and Diarrhea Categories and Scale) for Cohort II Diarrhea Categories: Cycle 2 Day 15 (n=36)	2.1 Score on a scale Standard Deviation 3.13	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Modified Oral Mucositis Daily Questionnaire (OMDQ) Scores (Mouth and Throat Soreness Categories and Scale, and Diarrhea Categories and Scale) for Cohort II Diarrhea Categories: Cycle 2 Day 22 (n=27)	2.7 Score on a scale Standard Deviation 3.10	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Modified Oral Mucositis Daily Questionnaire (OMDQ) Scores (Mouth and Throat Soreness Categories and Scale, and Diarrhea Categories and Scale) for Cohort II Diarrhea Categories: Cycle 3 Day 1 (n=19)	2.8 Score on a scale Standard Deviation 2.75	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Modified Oral Mucositis Daily Questionnaire (OMDQ) Scores (Mouth and Throat Soreness Categories and Scale, and Diarrhea Categories and Scale) for Cohort II Diarrhea Categories: Cycle 4 Day 1 (n=13)	2.3 Score on a scale Standard Deviation 3.14	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Modified Oral Mucositis Daily Questionnaire (OMDQ) Scores (Mouth and Throat Soreness Categories and Scale, and Diarrhea Categories and Scale) for Cohort II Diarrhea Categories: Cycle 5 Day 1 (n=10)	3.8 Score on a scale Standard Deviation 3.39	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Modified Oral Mucositis Daily Questionnaire (OMDQ) Scores (Mouth and Throat Soreness Categories and Scale, and Diarrhea Categories and Scale) for Cohort II Diarrhea Categories: Cycle 6 Day 1 (n=8)	1.9 Score on a scale Standard Deviation 2.22	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Modified Oral Mucositis Daily Questionnaire (OMDQ) Scores (Mouth and Throat Soreness Categories and Scale, and Diarrhea Categories and Scale) for Cohort II Diarrhea Categories: EoT (n=30)	1.9 Score on a scale Standard Deviation 3.39	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Modified Oral Mucositis Daily Questionnaire (OMDQ) Scores (Mouth and Throat Soreness Categories and Scale, and Diarrhea Categories and Scale) for Cohort II Diarrhea Categories: Follow-up (n=22)	-0.1 Score on a scale Standard Deviation 0.94	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Modified Oral Mucositis Daily Questionnaire (OMDQ) Scores (Mouth and Throat Soreness Categories and Scale, and Diarrhea Categories and Scale) for Cohort II Diarrhea Scale: Cycle 1 Day 8 (n=37)	1.2 Score on a scale Standard Deviation 1.89	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Modified Oral Mucositis Daily Questionnaire (OMDQ) Scores (Mouth and Throat Soreness Categories and Scale, and Diarrhea Categories and Scale) for Cohort II Diarrhea Scale: Cycle 1 Day 15 (n=37)	2.4 Score on a scale Standard Deviation 2.55	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Modified Oral Mucositis Daily Questionnaire (OMDQ) Scores (Mouth and Throat Soreness Categories and Scale, and Diarrhea Categories and Scale) for Cohort II Diarrhea Scale: Cycle 1 Day 22 (n=36)	3.0 Score on a scale Standard Deviation 2.96	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Modified Oral Mucositis Daily Questionnaire (OMDQ) Scores (Mouth and Throat Soreness Categories and Scale, and Diarrhea Categories and Scale) for Cohort II Diarrhea Scale: Cycle 2 Day 1 (n=37)	2.5 Score on a scale Standard Deviation 2.61	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Modified Oral Mucositis Daily Questionnaire (OMDQ) Scores (Mouth and Throat Soreness Categories and Scale, and Diarrhea Categories and Scale) for Cohort II Diarrhea Scale: Cycle 2 Day 8 (n=34)	2.0 Score on a scale Standard Deviation 2.75	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Modified Oral Mucositis Daily Questionnaire (OMDQ) Scores (Mouth and Throat Soreness Categories and Scale, and Diarrhea Categories and Scale) for Cohort II Diarrhea Scale: Cycle 2 Day 15 (n=35)	1.7 Score on a scale Standard Deviation 2.71	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Modified Oral Mucositis Daily Questionnaire (OMDQ) Scores (Mouth and Throat Soreness Categories and Scale, and Diarrhea Categories and Scale) for Cohort II Diarrhea Scale: Cycle 2 Day 22 (n=27)	2.0 Score on a scale Standard Deviation 2.16	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Modified Oral Mucositis Daily Questionnaire (OMDQ) Scores (Mouth and Throat Soreness Categories and Scale, and Diarrhea Categories and Scale) for Cohort II Diarrhea Scale: Cycle 3 Day 1 (n=19)	2.4 Score on a scale Standard Deviation 2.34	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Modified Oral Mucositis Daily Questionnaire (OMDQ) Scores (Mouth and Throat Soreness Categories and Scale, and Diarrhea Categories and Scale) for Cohort II Diarrhea Scale: Cycle 4 Day 1 (n=13)	1.8 Score on a scale Standard Deviation 2.13	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Modified Oral Mucositis Daily Questionnaire (OMDQ) Scores (Mouth and Throat Soreness Categories and Scale, and Diarrhea Categories and Scale) for Cohort II Diarrhea Scale: Cycle 5 Day 1 (n=10)	2.7 Score on a scale Standard Deviation 2.31	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Modified Oral Mucositis Daily Questionnaire (OMDQ) Scores (Mouth and Throat Soreness Categories and Scale, and Diarrhea Categories and Scale) for Cohort II Diarrhea Scale: Cycle 6 Day 1 (n=8)	1.5 Score on a scale Standard Deviation 1.93	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Modified Oral Mucositis Daily Questionnaire (OMDQ) Scores (Mouth and Throat Soreness Categories and Scale, and Diarrhea Categories and Scale) for Cohort II Diarrhea Scale: EoT (n=30)	1.6 Score on a scale Standard Deviation 2.87	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Modified Oral Mucositis Daily Questionnaire (OMDQ) Scores (Mouth and Throat Soreness Categories and Scale, and Diarrhea Categories and Scale) for Cohort II Diarrhea Scale: Follow-up (n=22)	-0.1 Score on a scale Standard Deviation 0.71	—	—	—	—

PRIMARY outcome

Timeframe: First 8 Weeks of Treatment

Population: Evaluable Population

SDAEI of all causality and all grades were evaluated in participants in Cohort II. These SDAEIs included dermatitis acneiform, dry skin, exfoliative rash, nail discoloration, nail disorder, paronychia, pruritus, rash, skin exfoliation, skin fissures, skin infection, skin laceration and skin ulcer.

95% CI calculated using exact method based on binomial distribution.

Outcome measures

Measure	Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo) n=59 Participants Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).	Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg) Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).	Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate) Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).	Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone) Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks \[range of 32 to 35 days\]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).	Cohort III (Dacomitinib 45 mg) Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
Percentage of Participants With SDAEI (All Causality, All Grade) in the First 8 Weeks of Treatment for Cohort II	79.7 Percentage of Participants Interval 67.2 to 89.0	—	—	—	—

PRIMARY outcome

Timeframe: First 8 Weeks of Treatment

Population: Evaluable Population

SDAEI of all causality and Grade ≥2 were evaluated in participants in Cohort II. These SDAEIs included dermatitis acneiform, dry skin, exfoliative rash, nail discoloration, nail disorder, paronychia, pruritus, rash, skin exfoliation, skin fissures, skin infection, skin laceration and skin ulcer. AEs were graded for severity using the NCI-CTCAE, Version 4.0.

95% CI calculated using exact method based on binomial distribution.

Outcome measures

Measure	Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo) n=59 Participants Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).	Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg) Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).	Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate) Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).	Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone) Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks \[range of 32 to 35 days\]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).	Cohort III (Dacomitinib 45 mg) Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
Percentage of Participants With SDAEI (All Causality, Grade ≥2) in the First 8 Weeks of Treatment for Cohort II	35.6 Percentage of Participants Interval 23.6 to 49.1	—	—	—	—

PRIMARY outcome

Timeframe: Cycles 1, 2, 3, 4, 5, and 6, EoT and Follow-up

Population: PRO Skindex Analysis Population

PROs of HRQoL and disease/treatment-related symptoms were assessed using Dermatologic Survey (Skindex-16) that assesses "bother". It includes 3 multi-item scales: symptoms, emotions & functioning. Individual scaled scores & total scores were determined. Skindex questions were transformed to a linear scale of 0 (never bothered) to 100 (always bothered). Subscale scores are an average of non-missing questions in a given scale if > 75% of total subscale questions are non-missing. The Total Score is an average of all non-missing questions in the Skindex if >75% of total questions are non-missing. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant.

Skindex completion criteria were defined as completion of 3 out of 4 items for questions 1 to 4, 6 out of 7 items for questions 5 to 11, 4 out of 5 items for questions 12 to 16 for the visit.

Outcome measures

Measure	Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo) n=40 Participants Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).	Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg) Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).	Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate) Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).	Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone) Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks \[range of 32 to 35 days\]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).	Cohort III (Dacomitinib 45 mg) Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) for Cohort II Symptoms: Cycle 2 Day 22 (n=30)	13.6 Score on a scale Standard Deviation 16.30	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) for Cohort II Functioning: Cycle 2 Day 22 (n=30)	7.2 Score on a scale Standard Deviation 10.06	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) for Cohort II Functioning: Follow-up (n=23)	5.4 Score on a scale Standard Deviation 18.55	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) for Cohort II Total: Cycle 1 Day 22 (n=40)	11.0 Score on a scale Standard Deviation 19.59	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) for Cohort II Total: Cycle 2 Day 1 (n=40)	9.6 Score on a scale Standard Deviation 17.38	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) for Cohort II Total: Cycle 5 Day 1 (n=11)	7.1 Score on a scale Standard Deviation 18.60	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) for Cohort II Symptoms: EoT (n=33)	10.4 Score on a scale Standard Deviation 21.33	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) for Cohort II Symptoms: Cycle 1 Day 8 (n=40)	0.1 Score on a scale Standard Deviation 8.31	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) for Cohort II Symptoms: Cycle 1 Day 15 (n=40)	11.4 Score on a scale Standard Deviation 21.25	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) for Cohort II Symptoms: Cycle 1 Day 22 (n=40)	11.4 Score on a scale Standard Deviation 18.17	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) for Cohort II Symptoms: Cycle 2 Day 1 (n=40)	11.4 Score on a scale Standard Deviation 19.84	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) for Cohort II Symptoms: Cycle 2 Day 8 (n=38)	13.5 Score on a scale Standard Deviation 20.88	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) for Cohort II Symptoms: Cycle 2 Day 15 (n=38)	14.7 Score on a scale Standard Deviation 17.83	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) for Cohort II Symptoms: Cycle 3 Day 1 (n=21)	12.7 Score on a scale Standard Deviation 19.56	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) for Cohort II Symptoms: Cycle 4 Day 1 (n=15)	11.9 Score on a scale Standard Deviation 18.69	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) for Cohort II Symptoms: Cycle 5 Day 1 (n=11)	8.0 Score on a scale Standard Deviation 22.24	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) for Cohort II Symptoms: Cycle 6 Day 1 (n=8)	12.0 Score on a scale Standard Deviation 32.15	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) for Cohort II Symptoms: Follow-up (n=23)	7.1 Score on a scale Standard Deviation 23.15	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) for Cohort II Emotion: Cycle 1 Day 8 (n=40)	1.0 Score on a scale Standard Deviation 11.79	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) for Cohort II Emotion: Cycle 1 Day 15 (n=40)	8.7 Score on a scale Standard Deviation 23.57	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) for Cohort II Emotion: Cycle 1 Day 22 (n=40)	12.3 Score on a scale Standard Deviation 24.63	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) for Cohort II Emotion: Cycle 2 Day 1 (n=40)	10.2 Score on a scale Standard Deviation 21.36	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) for Cohort II Emotion: Cycle 2 Day 8 (n=38)	10.3 Score on a scale Standard Deviation 21.77	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) for Cohort II Emotion: Cycle 2 Day 15 (n=37)	13.5 Score on a scale Standard Deviation 17.10	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) for Cohort II Emotion: Cycle 2 Day 22 (n= 30)	12.6 Score on a scale Standard Deviation 19.86	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) for Cohort II Emotion: Cycle 3 Day 1 (n=21)	11.0 Score on a scale Standard Deviation 17.97	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) for Cohort II Emotion: Cycle 4 Day 1 (n=14)	11.5 Score on a scale Standard Deviation 14.65	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) for Cohort II Emotion: Cycle 5 Day 1 (n=11)	7.8 Score on a scale Standard Deviation 21.43	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) for Cohort II Emotion: Cycle 6 Day 1 (n=8)	6.8 Score on a scale Standard Deviation 22.67	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) for Cohort II Emotion: EoT (n=33)	8.5 Score on a scale Standard Deviation 23.38	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) for Cohort II Emotion: Follow-up (n=23)	7.1 Score on a scale Standard Deviation 22.74	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) for Cohort II Functioning: Cycle 1 Day 8 (n=40)	0.5 Score on a scale Standard Deviation 3.58	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) for Cohort II Functioning: Cycle 1 Day 15 (n=40)	4.3 Score on a scale Standard Deviation 13.34	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) for Cohort II Functioning: Cycle 1 Day 22 (n=40)	8.8 Score on a scale Standard Deviation 17.55	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) for Cohort II Functioning: Cycle 2 Day 1 (n=40)	7.3 Score on a scale Standard Deviation 15.25	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) for Cohort II Functioning: Cycle 2 Day 8 (n=38)	6.2 Score on a scale Standard Deviation 15.33	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) for Cohort II Functioning: Cycle 2 Day 15 (n=38)	7.0 Score on a scale Standard Deviation 11.75	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) for Cohort II Functioning: Cycle 3 Day 1 (n=21)	5.9 Score on a scale Standard Deviation 8.09	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) for Cohort II Functioning: Cycle 4 Day 1 (n=15)	6.9 Score on a scale Standard Deviation 10.12	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) for Cohort II Functioning: Cycle 5 Day 1 (n=11)	5.5 Score on a scale Standard Deviation 12.93	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) for Cohort II Functioning: Cycle 6 Day 1 (n=8)	7.1 Score on a scale Standard Deviation 15.58	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) for Cohort II Functioning: EoT (n=33)	7.7 Score on a scale Standard Deviation 17.35	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) for Cohort II Total: Cycle 1 Day 8 (n=40)	0.6 Score on a scale Standard Deviation 6.83	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) for Cohort II Total: Cycle 1 Day 15 (n=40)	8.0 Score on a scale Standard Deviation 18.73	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) for Cohort II Total: Cycle 2 Day 8 (n=38)	9.9 Score on a scale Standard Deviation 17.79	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) for Cohort II Total: Cycle 2 Day 15 (n=38)	11.8 Score on a scale Standard Deviation 14.13	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) for Cohort II Total: Cycle 2 Day 22 (n=30)	11.2 Score on a scale Standard Deviation 14.14	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) for Cohort II Total: Cycle 3 Day 1 (n=21)	9.8 Score on a scale Standard Deviation 14.11	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) for Cohort II Total: Cycle 4 Day 1 (n=15)	10.2 Score on a scale Standard Deviation 12.49	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) for Cohort II Total: Cycle 6 Day 1 (n=8)	8.2 Score on a scale Standard Deviation 22.43	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) for Cohort II Total: EoT (n=33)	8.7 Score on a scale Standard Deviation 19.74	—	—	—	—
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) for Cohort II Total: Follow-up (n=23)	6.6 Score on a scale Standard Deviation 20.52	—	—	—	—

PRIMARY outcome

Timeframe: Cycle 1 Day 10: Pre-dose and 2, 4, 6, 24, 48, 72, 96, and 120 hours post-dose (the 120 hour sample was obtained on Day 15 pre-dose).

Population: Dose-Compliant participants only. Participants were considered dose-compliant when they received all planned doses at the same dose level right before sample collection.

AUC0-24 is the area under the plasma concentration-time curve (AUC) from time 0 to 24 hours post-dose. AUC0-120 is the AUC from time 0 to 120 hours post-dose. AUC was calculated by the linear trapezoidal method using a non-compartmental pharmacokinetic (PK) analysis.

ng*hr/mL = nanogram hours per milliliter

Outcome measures

Measure	Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo) n=23 Participants Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).	Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg) Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).	Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate) Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).	Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone) Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks \[range of 32 to 35 days\]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).	Cohort III (Dacomitinib 45 mg) Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
Mean Area Under the Plasma Concentration Time Curve From 0 to 24 Hours (AUC0-24) and From 0 to 120 Hours (AUC0-120) for Dacomitinib and Its Metabolite PF-05199265 on Cycle 1 Days 10 to 15 for Cohort III Dacomitinib AUC0-24	1712.88 ng*hr/mL Geometric Coefficient of Variation 35	—	—	—	—
Mean Area Under the Plasma Concentration Time Curve From 0 to 24 Hours (AUC0-24) and From 0 to 120 Hours (AUC0-120) for Dacomitinib and Its Metabolite PF-05199265 on Cycle 1 Days 10 to 15 for Cohort III Dacomitinib AUC0-120	5743.60 ng*hr/mL Geometric Coefficient of Variation 32	—	—	—	—
Mean Area Under the Plasma Concentration Time Curve From 0 to 24 Hours (AUC0-24) and From 0 to 120 Hours (AUC0-120) for Dacomitinib and Its Metabolite PF-05199265 on Cycle 1 Days 10 to 15 for Cohort III PF-05199265 AUC0-24	184.62 ng*hr/mL Geometric Coefficient of Variation 139	—	—	—	—
Mean Area Under the Plasma Concentration Time Curve From 0 to 24 Hours (AUC0-24) and From 0 to 120 Hours (AUC0-120) for Dacomitinib and Its Metabolite PF-05199265 on Cycle 1 Days 10 to 15 for Cohort III PF-05199265 AUC0-120	742.32 ng*hr/mL Geometric Coefficient of Variation 129	—	—	—	—

PRIMARY outcome

Timeframe: Cycle 1 Day 10: Pre-dose and 2, 4, 6, 24, 48, 72, 96, and 120 hours post-dose (the 120 hour sample was obtained on Day 15 pre-dose).

Population: Dose-Compliant participants only. Participants were considered dose-compliant when they received all planned doses at the same dose level right before sample collection.

Cmax was obtained from direct inspection of the data. ng/mL = nanograms per milliliter

Outcome measures

Measure	Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo) n=23 Participants Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).	Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg) Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).	Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate) Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).	Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone) Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks \[range of 32 to 35 days\]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).	Cohort III (Dacomitinib 45 mg) Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
Mean Maximum Observed Plasma Concentrations (Cmax) for Dacomitinib and Its Metabolite PF-05199265 on Cycle 1 Days 10 to 15 for Cohort III Dacomitinib Cmax	79.68 ng/mL Geometric Coefficient of Variation 36	—	—	—	—
Mean Maximum Observed Plasma Concentrations (Cmax) for Dacomitinib and Its Metabolite PF-05199265 on Cycle 1 Days 10 to 15 for Cohort III PF-05199265 Cmax	8.5176 ng/mL Geometric Coefficient of Variation 137	—	—	—	—

PRIMARY outcome

Timeframe: Cycle 1 Day 10: Pre-dose and 2, 4, 6, 24, 48, 72, 96, and 120 hours post-dose (the 120 hour sample was obtained on Day 15 pre-dose).

Population: Dose-Compliant participants only. Participants were considered dose-compliant when they received all planned doses at the same dose level right before sample collection.

Tmax was obtained from direct inspection of the data as the time of first occurence of Cmax.

Outcome measures

Measure	Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo) n=23 Participants Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).	Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg) Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).	Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate) Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).	Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone) Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks \[range of 32 to 35 days\]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).	Cohort III (Dacomitinib 45 mg) Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
Median Time of Occurrence of Cmax (Tmax) for Dacomitinib and Its Metabolite PF-05199265 on Cycle 1 Days 10 to 15 for Cohort III Dacomitinib Tmax	5.850 hours (hr) Full Range 53 • Interval 0.0 to 24.3	—	—	—	—
Median Time of Occurrence of Cmax (Tmax) for Dacomitinib and Its Metabolite PF-05199265 on Cycle 1 Days 10 to 15 for Cohort III PF-05199265 Tmax	5.980 hours (hr) Full Range 126 • Interval 0.0 to 24.3	—	—	—	—

SECONDARY outcome

Timeframe: Screening to the Post-Teatment Follow-Up Visit (at least 28 days and no more than 35 days after the end of dacomitinib treatment due to progression of disease, intolerance to dacomitinib treatment, or participant withdrawal)

Population: As Treated Population

Medications used concomitantly for SDAEIs, diarrhea and mucositis were evaluated for all participants who received dacomitinib on a continuous basis with a preemptive prophylactic (Cohorts I and II) or as an interrupted dosing regimen (Cohort III).

Outcome measures

Measure	Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo) n=66 Participants Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).	Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg) n=66 Participants Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).	Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate) n=7 Participants Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).	Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone) n=67 Participants Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks \[range of 32 to 35 days\]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).	Cohort III (Dacomitinib 45 mg) n=25 Participants Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
Percentage of Participants Receiving Any Concomitant Drug or Non-Drug Treatment for SDAEI, Diarrhea and Mucositis for Cohort I by Treatment Arm, Cohort II, and Cohort III Any Concomitant Drug	69.7 Percentage of Participants	60.6 Percentage of Participants	85.7 Percentage of Participants	82.1 Percentage of Participants	88.0 Percentage of Participants
Percentage of Participants Receiving Any Concomitant Drug or Non-Drug Treatment for SDAEI, Diarrhea and Mucositis for Cohort I by Treatment Arm, Cohort II, and Cohort III Any Non-Drug Treatment	16.7 Percentage of Participants	16.7 Percentage of Participants	42.9 Percentage of Participants	20.9 Percentage of Participants	44.0 Percentage of Participants

SECONDARY outcome

Timeframe: Cycle 2 Day 1: pre-dose and at 2, 4, 6, and 24 hours post-dose

Population: Dose-Compliant participants only. Participants were considered dose-compliant when they received at least 14 consecutive doses at the same dose level right before sample collection. Number of participants analyzed is the number of participants contributing to the summary statistics.

AUCtau was the AUC from time 0 to the end of the dosing interval, where the dosing interval was 24 hours. AUCtau was calculated by the linear/log trapezoidal method using a non-compartmental PK analysis.

Outcome measures

Measure	Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo) n=27 Participants Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).	Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg) n=27 Participants Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).	Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate) n=2 Participants Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).	Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone) Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks \[range of 32 to 35 days\]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).	Cohort III (Dacomitinib 45 mg) Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
Mean AUC From 0 to the End of the Dosing Interval (AUC0-tau) for Dacomitinib and Its Metabolite PF-05199265 on Cycle 2 Day 1 for Cohort I Dacomitinib AUC0-tau	1801.96 ng*hr/mL Geometric Coefficient of Variation 59	1869.23 ng*hr/mL Geometric Coefficient of Variation 37	1412.42 ng*hr/mL Geometric Coefficient of Variation 63	—	—
Mean AUC From 0 to the End of the Dosing Interval (AUC0-tau) for Dacomitinib and Its Metabolite PF-05199265 on Cycle 2 Day 1 for Cohort I PF-05199265 AUC0-tau	164.520 ng*hr/mL Geometric Coefficient of Variation 89	112.306 ng*hr/mL Geometric Coefficient of Variation 139	366.933 ng*hr/mL Geometric Coefficient of Variation 107	—	—

SECONDARY outcome

Timeframe: Cycle 2 Day 1: pre-dose and at 2, 4, 6, and 24 hours post-dose

Population: Dose-Compliant participants only. Participants were considered dose-compliant when they received at least 14 consecutive doses at the same dose level right before sample collection. Number of participants analyzed is the number of participants contributing to the summary statistics.

Cmax was obtained from direct inspection of the data.

Outcome measures

Measure	Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo) n=31 Participants Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).	Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg) n=27 Participants Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).	Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate) n=3 Participants Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).	Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone) Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks \[range of 32 to 35 days\]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).	Cohort III (Dacomitinib 45 mg) Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
Mean Cmax for Dacomitinib and Its Metabolite PF-05199265 on Cycle 2 Day 1 for Cohort I Dacomitinib Cmax	88.15 ng/mL Geometric Coefficient of Variation 57	89.79 ng/mL Geometric Coefficient of Variation 36	98.08 ng/mL Geometric Coefficient of Variation 89	—	—
Mean Cmax for Dacomitinib and Its Metabolite PF-05199265 on Cycle 2 Day 1 for Cohort I PF-05199265 Cmax	7.7426 ng/mL Geometric Coefficient of Variation 80	5.2901 ng/mL Geometric Coefficient of Variation 141	8.8545 ng/mL Geometric Coefficient of Variation 260	—	—

SECONDARY outcome

Timeframe: Cycle 2 Day 1: pre-dose and at 2, 4, 6, and 24 hours post-dose

Population: Dose-Compliant participants only. Participants were considered dose-compliant when they received at least 14 consecutive doses at the same dose level right before sample collection. Number of participants analyzed is the number of participants contributing to the summary statistics.

Tmax was obtained from direct inspection of the data as the time of first occurence of Cmax.

Outcome measures

Measure	Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo) n=31 Participants Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).	Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg) n=27 Participants Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).	Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate) n=3 Participants Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).	Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone) Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks \[range of 32 to 35 days\]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).	Cohort III (Dacomitinib 45 mg) Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
Median Tmax for Dacomitinib and Its Metabolite PF-05199265 on Cycle 2 Day 1 for Cohort I Dacomitinib Tmax	4.000 hr Full Range 67 • Interval 0.0 to 24.0	6.000 hr Full Range 67 • Interval 0.0 to 24.3	6.580 hr Full Range 108 • Interval 4.02 to 22.2	—	—
Median Tmax for Dacomitinib and Its Metabolite PF-05199265 on Cycle 2 Day 1 for Cohort I PF-05199265 Tmax	4.050 hr Full Range 82 • Interval 0.0 to 24.1	4.020 hr Full Range 125 • Interval 0.0 to 24.3	6.580 hr Full Range 105 • Interval 0.0 to 22.2	—	—

SECONDARY outcome

Timeframe: Cycle 2 Day 1: pre-dose and at 2, 4, 6, and 24 hours post-dose

Population: Dose-Compliant participants only. Participants were considered dose-compliant when they received at least 14 consecutive doses at the same dose level right before sample collection. Number of participants analyzed is the number of participants contributing to the summary statistics.

CL/F was calculated as dose/AUCtau.

Outcome measures

Measure	Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo) n=31 Participants Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).	Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg) n=27 Participants Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).	Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate) n=3 Participants Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).	Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone) Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks \[range of 32 to 35 days\]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).	Cohort III (Dacomitinib 45 mg) Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
Mean Apparent Clearance (CL/F) for Dacomitinib on Cycle 2 Day 1 for Cohort I	29.94 Liters per hour Geometric Coefficient of Variation 85	24.07 Liters per hour Geometric Coefficient of Variation 37	34.24 Liters per hour Geometric Coefficient of Variation 45	—	—

SECONDARY outcome

Timeframe: Cohorts I to III: Pre-dose on Day 1 of Cycle 3 to 10.

Population: Dose-Compliant participants only. Participants were considered dose-compliant when they received at least 14 consecutive doses at the same dose level right before sample collection in Cohorts I, II and III.

Ctrough was the pre-dose plasma concentration of dacomitinib at steady state obtained from direct inspection of the data.

Number of participants analyzed is the total number of participants in the treatment group in the indicated population, n is the number of participants contributing to the summary statistics.

Outcome measures

Measure	Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo) n=34 Participants Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).	Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg) n=32 Participants Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).	Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate) n=5 Participants Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).	Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone) n=15 Participants Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks \[range of 32 to 35 days\]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).	Cohort III (Dacomitinib 45 mg) n=23 Participants Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
Mean Plasma Trough Concentrations (Ctrough) for Dacomitinib by Visit for Cohorts I, II and III Cycle 6 Day 1 (n=2, 5, 1, 2, 10)	15.578 ng/mL Geometric Coefficient of Variation 1208	72.856 ng/mL Geometric Coefficient of Variation 47	46.000 ng/mL Geometric Coefficient of Variation NA Geometric mean coefficient of variation is not calculable as n=1.	9.201 ng/mL Geometric Coefficient of Variation 3760	52.603 ng/mL Geometric Coefficient of Variation 52
Mean Plasma Trough Concentrations (Ctrough) for Dacomitinib by Visit for Cohorts I, II and III Cycle 3 Day 1 (n=13, 15, 3, 14, 15)	65.477 ng/mL Geometric Coefficient of Variation 50	65.063 ng/mL Geometric Coefficient of Variation 55	56.212 ng/mL Geometric Coefficient of Variation 46	66.338 ng/mL Geometric Coefficient of Variation 58	55.780 ng/mL Geometric Coefficient of Variation 40
Mean Plasma Trough Concentrations (Ctrough) for Dacomitinib by Visit for Cohorts I, II and III Cycle 4 Day 1 (n=8, 7, 2, 5, 13)	61.592 ng/mL Geometric Coefficient of Variation 36	67.109 ng/mL Geometric Coefficient of Variation 29	65.466 ng/mL Geometric Coefficient of Variation 49	71.116 ng/mL Geometric Coefficient of Variation 49	55.644 ng/mL Geometric Coefficient of Variation 42
Mean Plasma Trough Concentrations (Ctrough) for Dacomitinib by Visit for Cohorts I, II and III Cycle 5 Day 1 (n=3, 6, 2, 3, 12)	89.970 ng/mL Geometric Coefficient of Variation 38	68.012 ng/mL Geometric Coefficient of Variation 39	69.649 ng/mL Geometric Coefficient of Variation 63	66.082 ng/mL Geometric Coefficient of Variation 33	53.116 ng/mL Geometric Coefficient of Variation 44
Mean Plasma Trough Concentrations (Ctrough) for Dacomitinib by Visit for Cohorts I, II and III Cycle 7 Day 1 (n=2, 1, 1, 1, 8)	59.086 ng/mL Geometric Coefficient of Variation 47	40.900 ng/mL Geometric Coefficient of Variation NA Geometric mean coefficient of variation is not calculable as n=1.	59.900 ng/mL Geometric Coefficient of Variation NA Geometric mean coefficient of variation is not calculable as n=1.	42.600 ng/mL Geometric Coefficient of Variation NA Geometric mean coefficient of variation is not calculable as n=1.	55.685 ng/mL Geometric Coefficient of Variation 21
Mean Plasma Trough Concentrations (Ctrough) for Dacomitinib by Visit for Cohorts I, II and III Cycle 8 Day 1 (n=2, 2, 1, 2, 8)	61.430 ng/mL Geometric Coefficient of Variation 90	58.988 ng/mL Geometric Coefficient of Variation 31	47.00 ng/mL Geometric Coefficient of Variation NA Geometric mean coefficient of variation is not calculable as n=1.	64.296 ng/mL Geometric Coefficient of Variation 35	51.559 ng/mL Geometric Coefficient of Variation 24
Mean Plasma Trough Concentrations (Ctrough) for Dacomitinib by Visit for Cohorts I, II and III Cycle 9 Day 1 (n=2, 2, 1, 2, 6)	64.747 ng/mL Geometric Coefficient of Variation 72	58.928 ng/mL Geometric Coefficient of Variation 31	46.000 ng/mL Geometric Coefficient of Variation NA Geometric mean coefficient of variation is not calculable as n=1.	64.115 ng/mL Geometric Coefficient of Variation 30	44.865 ng/mL Geometric Coefficient of Variation 50
Mean Plasma Trough Concentrations (Ctrough) for Dacomitinib by Visit for Cohorts I, II and III Cycle 10 Day 1 (n=1, 2, 1, 2, 4)	51.400 ng/mL Geometric Coefficient of Variation NA Geometric mean coefficient of variation is not calculable as n=1.	54.041 ng/mL Geometric Coefficient of Variation 48	58.800 ng/mL Geometric Coefficient of Variation NA Geometric mean coefficient of variation is not calculable as n=1.	71.695 ng/mL Geometric Coefficient of Variation 26	55.362 ng/mL Geometric Coefficient of Variation 32

SECONDARY outcome

Timeframe: Cohorts I to III: Pre-dose on Day 1 of Cycle 3 to 10.

Population: Dose-Compliant participants only. Participants were considered dose-compliant when they received at least 14 consecutive doses at the same dose level right before sample collection in Cohorts I, II and III.

Ctrough was the pre-dose plasma concentration of the dacomitinib metabolite PF-05199265 at steady state obtained from direct inspection of the data.

Number of participants analyzed is the total number of participants in the treatment group in the indicated population, n is the number of participants contributing to the summary statistics.

Outcome measures

Measure	Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo) n=34 Participants Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).	Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg) n=32 Participants Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).	Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate) n=5 Participants Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).	Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone) n=15 Participants Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks \[range of 32 to 35 days\]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).	Cohort III (Dacomitinib 45 mg) n=23 Participants Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
Mean Plasma Ctrough for PF-05199265 by Visit for Cohorts I, II and III Cycle 4 Day 1 (n=8, 7, 2, 5, 13)	5.555 ng/mL Geometric Coefficient of Variation 71	5.271 ng/mL Geometric Coefficient of Variation 242	8.522 ng/mL Geometric Coefficient of Variation 15	6.848 ng/mL Geometric Coefficient of Variation 82	11.759 ng/mL Geometric Coefficient of Variation 113
Mean Plasma Ctrough for PF-05199265 by Visit for Cohorts I, II and III Cycle 3 Day 1 (n=13, 15, 3, 14, 15)	6.988 ng/mL Geometric Coefficient of Variation 60	4.653 ng/mL Geometric Coefficient of Variation 133	10.220 ng/mL Geometric Coefficient of Variation 11	7.814 ng/mL Geometric Coefficient of Variation 59	9.967 ng/mL Geometric Coefficient of Variation 149
Mean Plasma Ctrough for PF-05199265 by Visit for Cohorts I, II and III Cycle 5 Day 1 (n=3, 6, 2, 3, 12)	4.356 ng/mL Geometric Coefficient of Variation 55	4.989 ng/mL Geometric Coefficient of Variation 58	8.522 ng/mL Geometric Coefficient of Variation 10	5.850 ng/mL Geometric Coefficient of Variation 115	10.510 ng/mL Geometric Coefficient of Variation 124
Mean Plasma Ctrough for PF-05199265 by Visit for Cohorts I, II and III Cycle 6 Day 1 (n=2, 5, 1, 2, 10)	5.020 ng/mL Geometric Coefficient of Variation 70	6.523 ng/mL Geometric Coefficient of Variation 123	8.150 ng/mL Geometric Coefficient of Variation NA Geometric mean coefficient of variation is not calculable as n=1.	1.261 ng/mL Geometric Coefficient of Variation 937	7.844 ng/mL Geometric Coefficient of Variation 125
Mean Plasma Ctrough for PF-05199265 by Visit for Cohorts I, II and III Cycle 7 Day 1 (n=2, 1, 1, 1, 8)	4.850 ng/mL Geometric Coefficient of Variation 49	23.900 ng/mL Geometric Coefficient of Variation NA Geometric mean coefficient of variation is not calculable as n=1.	8.560 ng/mL Geometric Coefficient of Variation NA Geometric mean coefficient of variation is not calculable as n=1.	6.680 ng/mL Geometric Coefficient of Variation NA Geometric mean coefficient of variation is not calculable as n=1.	8.203 ng/mL Geometric Coefficient of Variation 105
Mean Plasma Ctrough for PF-05199265 by Visit for Cohorts I, II and III Cycle 8 Day 1 (n=2, 2, 1, 2, 8)	5.349 ng/mL Geometric Coefficient of Variation 54	6.085 ng/mL Geometric Coefficient of Variation 476	10.100 ng/mL Geometric Coefficient of Variation NA Geometric mean coefficient of variation is not calculable as n=1.	10.844 ng/mL Geometric Coefficient of Variation 38	8.205 ng/mL Geometric Coefficient of Variation 117
Mean Plasma Ctrough for PF-05199265 by Visit for Cohorts I, II and III Cycle 9 Day 1 (n=2, 2, 1, 2, 6)	4.271 ng/mL Geometric Coefficient of Variation 34	6.448 ng/mL Geometric Coefficient of Variation 612	9.720 ng/mL Geometric Coefficient of Variation NA Geometric mean coefficient of variation is not calculable as n=1.	9.159 ng/mL Geometric Coefficient of Variation 58	6.963 ng/mL Geometric Coefficient of Variation 88
Mean Plasma Ctrough for PF-05199265 by Visit for Cohorts I, II and III Cycle 10 Day 1 (n=1, 2, 1, 2, 4)	3.460 ng/mL Geometric Coefficient of Variation NA Geometric mean coefficient of variation is not calculable as n=1.	6.892 ng/mL Geometric Coefficient of Variation 305	10.700 ng/mL Geometric Coefficient of Variation NA Geometric mean coefficient of variation is not calculable as n=1.	9.442 ng/mL Geometric Coefficient of Variation 26	6.364 ng/mL Geometric Coefficient of Variation 154

Adverse Events

Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)

Serious events: 25 serious events

Other events: 65 other events

Deaths: 0 deaths

Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)

Serious events: 27 serious events

Other events: 66 other events

Deaths: 0 deaths

Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)

Serious events: 3 serious events

Other events: 7 other events

Deaths: 0 deaths

Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)

Serious events: 22 serious events

Other events: 64 other events

Deaths: 0 deaths

Cohort III (Dacomitinib 45 mg)

Serious events: 6 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Measure	Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo) n=66 participants at risk Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).	Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg) n=66 participants at risk Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).	Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate) n=7 participants at risk Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).	Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone) n=67 participants at risk Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks \[range of 32 to 35 days\]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).	Cohort III (Dacomitinib 45 mg) n=25 participants at risk Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
Blood and lymphatic system disorders Anaemia	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	4.0% 1/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	4.0% 1/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Blood and lymphatic system disorders Pancytopenia	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Cardiac disorders Cardiac arrest	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Cardiac disorders Cardiac tamponade	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Cardiac disorders Cardiogenic shock	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Cardiac disorders Myocardial infarction	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Cardiac disorders Pericardial effusion	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Cardiac disorders Supraventricular tachycardia	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	3.0% 2/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Eye disorders Diplopia	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Gastrointestinal disorders Abdominal pain	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Gastrointestinal disorders Constipation	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Gastrointestinal disorders Diarrhoea	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	3.0% 2/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	4.0% 1/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Gastrointestinal disorders Duodenal ulcer perforation	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Gastrointestinal disorders Gastrointestinal haemorrhage	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Gastrointestinal disorders Intestinal obstruction	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Gastrointestinal disorders Intra-abdominal haemorrhage	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Gastrointestinal disorders Nausea	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	6.1% 4/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	4.0% 1/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Gastrointestinal disorders Vomiting	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	4.5% 3/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	3.0% 2/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	4.0% 1/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
General disorders Asthenia	3.0% 2/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
General disorders Chest pain	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	4.0% 1/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
General disorders Disease progression	10.6% 7/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	10.6% 7/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	11.9% 8/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	4.0% 1/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
General disorders Mucosal inflammation	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
General disorders Non-cardiac chest pain	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
General disorders Pain	3.0% 2/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
General disorders Pyrexia	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Infections and infestations Acute sinusitis	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	4.0% 1/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Infections and infestations Cholecystitis infective	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Infections and infestations Clostridium difficile colitis	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Infections and infestations Enterocolitis infectious	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Infections and infestations Gastroenteritis	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Infections and infestations Osteomyelitis	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Infections and infestations Pneumonia	3.0% 2/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	7.5% 5/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	4.0% 1/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Infections and infestations Septic shock	3.0% 2/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Injury, poisoning and procedural complications Fall	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	4.0% 1/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Injury, poisoning and procedural complications Rib fracture	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	4.0% 1/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Injury, poisoning and procedural complications Toxicity to various agents	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Investigations Blood creatinine increased	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Investigations Platelet count decreased	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	4.0% 1/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Investigations Weight decreased	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Metabolism and nutrition disorders Dehydration	7.6% 5/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	4.5% 3/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	4.0% 1/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Metabolism and nutrition disorders Electrolyte imbalance	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	4.0% 1/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Metabolism and nutrition disorders Metabolic alkalosis	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Musculoskeletal and connective tissue disorders Back pain	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant pleural effusion	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer metastatic	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Nervous system disorders Aphasia	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Nervous system disorders Cerebral haemorrhage	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Nervous system disorders Cerebral infarction	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Nervous system disorders Cerebrovascular accident	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Nervous system disorders Transient ischaemic attack	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Renal and urinary disorders Acute kidney injury	4.5% 3/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Renal and urinary disorders Haematuria	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Renal and urinary disorders Hydronephrosis	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Renal and urinary disorders Renal impairment	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	3.0% 2/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	4.0% 1/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	3.0% 2/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Respiratory, thoracic and mediastinal disorders Pneumothorax	3.0% 2/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	3.0% 2/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	3.0% 2/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Skin and subcutaneous tissue disorders Perivascular dermatitis	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Skin and subcutaneous tissue disorders Subcutaneous emphysema	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Vascular disorders Deep vein thrombosis	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Vascular disorders Embolism	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	4.0% 1/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Vascular disorders Hypotension	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Vascular disorders Hypovolaemic shock	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.

Other adverse events

Measure	Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo) n=66 participants at risk Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).	Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg) n=66 participants at risk Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).	Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate) n=7 participants at risk Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).	Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone) n=67 participants at risk Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks \[range of 32 to 35 days\]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).	Cohort III (Dacomitinib 45 mg) n=25 participants at risk Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
Investigations Alanine aminotransferase increased	3.0% 2/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	28.6% 2/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	3.0% 2/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	12.0% 3/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Blood and lymphatic system disorders Anaemia	15.2% 10/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	10.6% 7/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	42.9% 3/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	7.5% 5/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	12.0% 3/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Cardiac disorders Tachycardia	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	6.1% 4/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	4.5% 3/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Ear and labyrinth disorders Deafness	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Ear and labyrinth disorders Tinnitus	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Eye disorders Dry eye	7.6% 5/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	6.1% 4/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	3.0% 2/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	12.0% 3/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Eye disorders Eye pain	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	8.0% 2/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Eye disorders Ocular hyperaemia	3.0% 2/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	8.0% 2/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Eye disorders Vision blurred	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	28.6% 2/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	4.0% 1/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Gastrointestinal disorders Abdominal distension	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	3.0% 2/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	8.0% 2/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Gastrointestinal disorders Abdominal pain	10.6% 7/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	10.6% 7/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	4.5% 3/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	12.0% 3/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Gastrointestinal disorders Abdominal pain upper	6.1% 4/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	4.5% 3/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	3.0% 2/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	8.0% 2/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Gastrointestinal disorders Cheilitis	4.5% 3/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	4.5% 3/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	4.0% 1/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Gastrointestinal disorders Constipation	13.6% 9/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	21.2% 14/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	28.6% 2/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	11.9% 8/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	12.0% 3/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Gastrointestinal disorders Diarrhoea	81.8% 54/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	78.8% 52/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	100.0% 7/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	80.6% 54/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	92.0% 23/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Gastrointestinal disorders Dry mouth	6.1% 4/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	7.6% 5/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	6.0% 4/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	24.0% 6/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Gastrointestinal disorders Dyspepsia	4.5% 3/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	15.2% 10/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	3.0% 2/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	12.0% 3/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Gastrointestinal disorders Food poisoning	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Gastrointestinal disorders Gastritis	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Gastrointestinal disorders Glossodynia	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	6.1% 4/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Gastrointestinal disorders Haemorrhoids	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	8.0% 2/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Gastrointestinal disorders Lip swelling	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Gastrointestinal disorders Nausea	42.4% 28/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	47.0% 31/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	28.6% 2/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	29.9% 20/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	16.0% 4/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Gastrointestinal disorders Oesophagitis	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Gastrointestinal disorders Oral mucosal erythema	3.0% 2/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Gastrointestinal disorders Oral pain	3.0% 2/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	6.1% 4/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	10.4% 7/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	8.0% 2/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Gastrointestinal disorders Stomatitis	15.2% 10/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	18.2% 12/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	42.9% 3/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	20.9% 14/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	64.0% 16/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Gastrointestinal disorders Vomiting	24.2% 16/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	34.8% 23/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	42.9% 3/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	20.9% 14/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	20.0% 5/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
General disorders Asthenia	6.1% 4/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	10.6% 7/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	28.6% 2/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	4.5% 3/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	4.0% 1/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
General disorders Chest discomfort	3.0% 2/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	8.0% 2/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
General disorders Chills	7.6% 5/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	57.1% 4/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	4.0% 1/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
General disorders Fatigue	36.4% 24/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	40.9% 27/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	42.9% 3/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	29.9% 20/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	20.0% 5/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
General disorders Influenza like illness	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	16.0% 4/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
General disorders Malaise	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	3.0% 2/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
General disorders Mucosal inflammation	28.8% 19/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	31.8% 21/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	28.6% 2/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	17.9% 12/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	20.0% 5/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
General disorders Oedema peripheral	9.1% 6/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	6.1% 4/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	6.0% 4/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	12.0% 3/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
General disorders Pain	7.6% 5/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	10.6% 7/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
General disorders Pyrexia	4.5% 3/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	6.1% 4/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	16.0% 4/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Hepatobiliary disorders Cholelithiasis	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Immune system disorders Immunosuppression	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Infections and infestations Bronchitis	3.0% 2/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	3.0% 2/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	8.0% 2/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Infections and infestations Cellulitis	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	8.0% 2/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Infections and infestations Cystitis	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	4.0% 1/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Infections and infestations Folliculitis	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	28.6% 2/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Infections and infestations Fungal skin infection	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	3.0% 2/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	6.0% 4/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Infections and infestations Herpes zoster	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	8.0% 2/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Infections and infestations Mucosal infection	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Infections and infestations Otitis externa	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Infections and infestations Paronychia	18.2% 12/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	15.2% 10/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	42.9% 3/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	13.4% 9/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	64.0% 16/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Infections and infestations Pneumonia	3.0% 2/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	3.0% 2/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	3.0% 2/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	8.0% 2/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Infections and infestations Rash pustular	6.1% 4/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	3.0% 2/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	10.4% 7/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	8.0% 2/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Infections and infestations Upper respiratory tract infection	3.0% 2/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	4.5% 3/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	28.0% 7/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Infections and infestations Urinary tract infection	12.1% 8/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	10.6% 7/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	3.0% 2/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	12.0% 3/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Infections and infestations Vulvovaginal mycotic infection	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	3.0% 2/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Injury, poisoning and procedural complications Contusion	4.5% 3/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	8.0% 2/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Injury, poisoning and procedural complications Fall	7.6% 5/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	4.0% 1/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Injury, poisoning and procedural complications Limb injury	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Investigations Aspartate aminotransferase increased	9.1% 6/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	4.5% 3/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	12.0% 3/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Investigations Blood alkaline phosphatase increased	4.5% 3/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	6.0% 4/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	4.0% 1/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Investigations Blood creatinine increased	12.1% 8/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	7.6% 5/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	4.5% 3/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	4.0% 1/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Investigations Transaminases increased	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Investigations Weight decreased	22.7% 15/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	22.7% 15/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	28.6% 2/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	11.9% 8/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	28.0% 7/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Metabolism and nutrition disorders Decreased appetite	36.4% 24/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	33.3% 22/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	42.9% 3/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	37.3% 25/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	56.0% 14/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Metabolism and nutrition disorders Dehydration	22.7% 15/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	22.7% 15/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	13.4% 9/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	4.0% 1/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	3.0% 2/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Metabolism and nutrition disorders Hypermagnesaemia	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Metabolism and nutrition disorders Hypoalbuminaemia	12.1% 8/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	3.0% 2/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	8.0% 2/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Metabolism and nutrition disorders Hypokalaemia	13.6% 9/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	15.2% 10/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.9% 10/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	8.0% 2/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Metabolism and nutrition disorders Hypomagnesaemia	10.6% 7/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	21.2% 14/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	11.9% 8/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	4.0% 1/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Metabolism and nutrition disorders Hyponatraemia	6.1% 4/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	10.6% 7/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	28.6% 2/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	3.0% 2/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	8.0% 2/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Metabolism and nutrition disorders Hypophosphataemia	3.0% 2/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	4.0% 1/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Musculoskeletal and connective tissue disorders Arthralgia	3.0% 2/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	10.6% 7/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	6.0% 4/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Musculoskeletal and connective tissue disorders Back pain	4.5% 3/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	7.6% 5/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	9.0% 6/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	12.0% 3/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Musculoskeletal and connective tissue disorders Flank pain	3.0% 2/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	8.0% 2/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Musculoskeletal and connective tissue disorders Muscle spasms	6.1% 4/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	9.1% 6/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	8.0% 2/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	4.5% 3/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	6.1% 4/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	7.5% 5/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	4.0% 1/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	3.0% 2/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	9.0% 6/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	24.0% 6/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Musculoskeletal and connective tissue disorders Myalgia	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	3.0% 2/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	20.0% 5/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	4.5% 3/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	6.1% 4/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	8.0% 2/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Nervous system disorders Dizziness	9.1% 6/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	3.0% 2/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	3.0% 2/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	16.0% 4/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Nervous system disorders Dysgeusia	7.6% 5/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	10.6% 7/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	10.4% 7/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	8.0% 2/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Skin and subcutaneous tissue disorders Dry skin	40.9% 27/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	28.8% 19/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	28.6% 2/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	22.4% 15/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	56.0% 14/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Nervous system disorders Headache	7.6% 5/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	7.6% 5/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	20.0% 5/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Nervous system disorders Hypoaesthesia	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	3.0% 2/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	16.0% 4/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Psychiatric disorders Anxiety	6.1% 4/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	4.5% 3/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	4.5% 3/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	4.0% 1/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Psychiatric disorders Confusional state	3.0% 2/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	3.0% 2/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	8.0% 2/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Psychiatric disorders Insomnia	6.1% 4/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	13.6% 9/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	4.5% 3/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	16.0% 4/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Renal and urinary disorders Dysuria	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Renal and urinary disorders Haematuria	4.5% 3/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	7.5% 5/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	12.0% 3/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Skin and subcutaneous tissue disorders Erythema	18.2% 12/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	15.2% 10/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	10.4% 7/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	12.0% 3/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Renal and urinary disorders Pollakiuria	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	4.5% 3/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	4.0% 1/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Renal and urinary disorders Proteinuria	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	4.0% 1/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	12.0% 3/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Reproductive system and breast disorders Genital rash	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Respiratory, thoracic and mediastinal disorders Cough	12.1% 8/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	9.1% 6/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	42.9% 3/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	10.4% 7/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	32.0% 8/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Respiratory, thoracic and mediastinal disorders Dysphonia	3.0% 2/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	4.5% 3/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	8.0% 2/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	12.1% 8/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	13.6% 9/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	28.6% 2/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	11.9% 8/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	16.0% 4/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Respiratory, thoracic and mediastinal disorders Epistaxis	15.2% 10/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	6.1% 4/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	9.0% 6/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	28.0% 7/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Respiratory, thoracic and mediastinal disorders Haemoptysis	6.1% 4/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	9.1% 6/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	4.5% 3/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	8.0% 2/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Respiratory, thoracic and mediastinal disorders Nasal congestion	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	20.0% 5/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	7.6% 5/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	3.0% 2/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	3.0% 2/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	8.0% 2/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	6.1% 4/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	3.0% 2/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	3.0% 2/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	28.0% 7/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	4.5% 3/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	3.0% 2/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	28.0% 7/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	10.6% 7/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	3.0% 2/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	28.6% 2/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	4.5% 3/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	16.0% 4/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Respiratory, thoracic and mediastinal disorders Sputum increased	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Skin and subcutaneous tissue disorders Alopecia	3.0% 2/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	6.1% 4/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	4.5% 3/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	16.0% 4/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Skin and subcutaneous tissue disorders Dermatitis acneiform	24.2% 16/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	18.2% 12/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	28.6% 2/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	29.9% 20/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	72.0% 18/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Skin and subcutaneous tissue disorders Hypertrichosis	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	28.6% 2/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Skin and subcutaneous tissue disorders Ingrowing nail	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	10.6% 7/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	7.6% 5/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	6.0% 4/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	24.0% 6/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Skin and subcutaneous tissue disorders Papule	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	3.0% 2/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	4.0% 1/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Skin and subcutaneous tissue disorders Pruritus	10.6% 7/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	19.7% 13/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	42.9% 3/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	19.4% 13/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	68.0% 17/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Skin and subcutaneous tissue disorders Pruritus generalised	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	3.0% 2/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Skin and subcutaneous tissue disorders Rash	42.4% 28/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	43.9% 29/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	71.4% 5/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	37.3% 25/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	20.0% 5/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Skin and subcutaneous tissue disorders Rash erythematous	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	1.5% 1/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	4.0% 1/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Skin and subcutaneous tissue disorders Rash maculo-papular	4.5% 3/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	12.1% 8/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	11.9% 8/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	28.0% 7/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Skin and subcutaneous tissue disorders Rash papular	3.0% 2/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	6.1% 4/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	8.0% 2/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Skin and subcutaneous tissue disorders Skin exfoliation	7.6% 5/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	12.1% 8/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	7.5% 5/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Skin and subcutaneous tissue disorders Skin fissures	3.0% 2/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	9.1% 6/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	13.4% 9/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	20.0% 5/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Skin and subcutaneous tissue disorders Skin lesion	6.1% 4/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	3.0% 2/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Skin and subcutaneous tissue disorders Trichorrhexis	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	28.6% 2/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Vascular disorders Hyperaemia	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Vascular disorders Hypertension	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	8.0% 2/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.
Vascular disorders Hypotension	13.6% 9/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	4.5% 3/66 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	14.3% 1/7 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	6.0% 4/67 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.	0.00% 0/25 • Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks. The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of treatment.

Additional Information

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Results disclosure agreements

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