Trial Outcomes & Findings for Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Alobresib (Formerly GS-5829) in Adults With Advanced Solid Tumors and Lymphomas and in Combination With Exemestane or Fulvestrant in Adults With Estrogen Receptor Positive Breast Cancer (NCT NCT02392611)

NCT ID: NCT02392611

Last Updated: 2020-12-29

Results Overview

A DLT was a toxicity, considered possibly related to alobresib, and which occurred during DLT assessment window (Day 1 through Cycle 1 Day 28) in each cohort: Grade ≥ 4 neutropenia (absolute neutrophil count \[ANC\] \< 500/mm\^3); Grade ≥3 neutropenia (ANC\< 1000/mm\^3) with fever (a single temperature of \> 38.3°C or a sustained temperature of ≥ 38°C for more than 1 hour \[hr\]); Grade ≥ 3 thrombocytopenia; Grade ≥ 2 bleeding; Grade ≥ 3 non hematologic toxicity, except Grade 3 nausea or emesis with maximum duration of 48 hrs on adequate medical therapy and Grade 3 diarrhea which persists for \< 72 hrs in absence of maximal medical therapy; Grade ≥ 2 non hematologic treatment-emergent adverse event (TEAE) of potential clinical significance; treatment interruption ≥ 7 days due to unresolved toxicity; and any Grade 3 or 4 elevation in aspartate aminotransferase (AST) or alanine aminotransferase (ALT) associated with a Grade 2 elevation in bilirubin that is at least possibly related to alobresib.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 33 participants
• Primary outcome timeframe: Baseline (Day 1) up to 28 days
• Results posted on: 2020-12-29

Participant Flow

Participants were enrolled at study sites in United states. The first participant was screened on 16 March 2015. The last study visit occurred on 11 October 2017.

37 participants were screened.

Participant milestones

Measure	Monotherapy: Alobresib 0.6 mg Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 0.6 mg orally once daily on Study Day 1 through Cycle 1 Day 28 (C1D28) of 28 days cycle to determine the maximum tolerated dose (MTD).	Monotherapy: Alobresib 1.4 mg Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 1.4 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Monotherapy: Alobresib 2 mg Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 2 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Monotherapy: Alobresib 3 mg Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 3 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Monotherapy: Alobresib 4 mg Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 4 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Monotherapy: Alobresib 6 mg Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 6 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Combination Therapy: Alobresib 2 mg + Exemestane Participants with advanced stage estrogen receptor positive breast cancer for whom no standard curative therapy existed, received alobresib tablets at a dose of 2 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle in combination with exemestane 25 mg tablets administered orally once daily on Cycle 1 Day 1 (C1D1) of 28 days cycle.	Combination Therapy: Alobresib 2 mg + Fulvestrant Participants with advanced stage estrogen receptor positive breast cancer for whom no standard curative therapy existed, received alobresib tablets at a dose of 2 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle in combination with fulvestrant 500 mg administered intramuscularly on C1D1 of 28 days cycle and every 28 days (± 3 days).	Combination Therapy: Alobresib 3 mg + Fulvestrant Participants with advanced stage estrogen receptor positive breast cancer for whom no standard curative therapy existed, received alobresib tablets at a dose of 3 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle in combination with fulvestrant 500 mg administered intramuscularly on C1D1 of 28 days cycle and every 28 days (± 3 days).
Overall Study STARTED	2	1	1	9	6	4	4	3	3
Overall Study COMPLETED	1	1	1	3	5	3	3	3	3
Overall Study NOT COMPLETED	1	0	0	6	1	1	1	0	0

Reasons for withdrawal

Measure	Monotherapy: Alobresib 0.6 mg Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 0.6 mg orally once daily on Study Day 1 through Cycle 1 Day 28 (C1D28) of 28 days cycle to determine the maximum tolerated dose (MTD).	Monotherapy: Alobresib 1.4 mg Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 1.4 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Monotherapy: Alobresib 2 mg Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 2 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Monotherapy: Alobresib 3 mg Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 3 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Monotherapy: Alobresib 4 mg Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 4 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Monotherapy: Alobresib 6 mg Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 6 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Combination Therapy: Alobresib 2 mg + Exemestane Participants with advanced stage estrogen receptor positive breast cancer for whom no standard curative therapy existed, received alobresib tablets at a dose of 2 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle in combination with exemestane 25 mg tablets administered orally once daily on Cycle 1 Day 1 (C1D1) of 28 days cycle.	Combination Therapy: Alobresib 2 mg + Fulvestrant Participants with advanced stage estrogen receptor positive breast cancer for whom no standard curative therapy existed, received alobresib tablets at a dose of 2 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle in combination with fulvestrant 500 mg administered intramuscularly on C1D1 of 28 days cycle and every 28 days (± 3 days).	Combination Therapy: Alobresib 3 mg + Fulvestrant Participants with advanced stage estrogen receptor positive breast cancer for whom no standard curative therapy existed, received alobresib tablets at a dose of 3 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle in combination with fulvestrant 500 mg administered intramuscularly on C1D1 of 28 days cycle and every 28 days (± 3 days).
Overall Study Adverse Event	0	0	0	1	0	0	0	0	0
Overall Study Progressive disease	0	0	0	2	1	0	0	0	0
Overall Study Death	1	0	0	0	0	1	0	0	0
Overall Study Withdrawal by Subject	0	0	0	1	0	0	0	0	0
Overall Study Lost to Follow-up	0	0	0	0	0	0	1	0	0
Overall Study Enrolled, not treated	0	0	0	2	0	0	0	0	0

Baseline Characteristics

Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Alobresib (Formerly GS-5829) in Adults With Advanced Solid Tumors and Lymphomas and in Combination With Exemestane or Fulvestrant in Adults With Estrogen Receptor Positive Breast Cancer

Baseline characteristics by cohort

Measure	Monotherapy: Alobresib 0.6 mg n=2 Participants Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 0.6 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Monotherapy: Alobresib 1.4 mg n=1 Participants Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 1.4 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Monotherapy: Alobresib 2 mg n=1 Participants Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 2 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Monotherapy: Alobresib 3 mg n=7 Participants Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 3 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Monotherapy: Alobresib 4 mg n=6 Participants Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 4 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Monotherapy: Alobresib 6 mg n=4 Participants Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 6 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Combination Therapy: Alobresib 2 mg + Exemestane n=4 Participants Participants with advanced stage estrogen receptor positive breast cancer for whom no standard curative therapy existed, received alobresib tablets at a dose of 2 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle in combination with exemestane 25 mg tablets administered orally once daily on C1D1 of 28 days cycle.	Combination Therapy: Alobresib 2 mg + Fulvestrant n=3 Participants Participants with advanced stage estrogen receptor positive breast cancer for whom no standard curative therapy existed, received alobresib tablets at a dose of 2 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle in combination with fulvestrant 500 mg administered intramuscularly on C1D1 of 28 days cycle and every 28 days (± 3 days).	Combination Therapy: Alobresib 3 mg + Fulvestrant n=3 Participants Participants with advanced stage estrogen receptor positive breast cancer for whom no standard curative therapy existed, received alobresib tablets at a dose of 3 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle in combination with fulvestrant 500 mg administered intramuscularly on C1D1 of 28 days cycle and every 28 days (± 3 days).	Total n=31 Participants Total of all reporting groups
Sex: Female, Male Male	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	9 Participants n=42 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=8 Participants	3 Participants n=8 Participants	0 Participants n=24 Participants	2 Participants n=42 Participants	12 Participants n=42 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants	4 Participants n=21 Participants	2 Participants n=8 Participants	1 Participants n=8 Participants	3 Participants n=24 Participants	1 Participants n=42 Participants	19 Participants n=42 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=8 Participants	4 Participants n=8 Participants	3 Participants n=24 Participants	3 Participants n=42 Participants	22 Participants n=42 Participants
Race/Ethnicity, Customized Ethnicity · Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	4 Participants n=42 Participants
Race/Ethnicity, Customized Ethnicity · Not Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	6 Participants n=4 Participants	6 Participants n=21 Participants	2 Participants n=8 Participants	4 Participants n=8 Participants	3 Participants n=24 Participants	3 Participants n=42 Participants	26 Participants n=42 Participants
Race/Ethnicity, Customized Ethnicity · Not Permitted	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants
Race/Ethnicity, Customized Race · Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants
Race/Ethnicity, Customized Race · White	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	7 Participants n=4 Participants	6 Participants n=21 Participants	3 Participants n=8 Participants	3 Participants n=8 Participants	3 Participants n=24 Participants	3 Participants n=42 Participants	29 Participants n=42 Participants
Race/Ethnicity, Customized Race · Other	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1) up to 28 days

Population: The Full Analysis Set included all participants who received at least 1 dose of study drug.

A DLT was a toxicity, considered possibly related to alobresib, and which occurred during DLT assessment window (Day 1 through Cycle 1 Day 28) in each cohort: Grade ≥ 4 neutropenia (absolute neutrophil count [ANC] < 500/mm^3); Grade ≥3 neutropenia (ANC< 1000/mm^3) with fever (a single temperature of > 38.3°C or a sustained temperature of ≥ 38°C for more than 1 hour [hr]); Grade ≥ 3 thrombocytopenia; Grade ≥ 2 bleeding; Grade ≥ 3 non hematologic toxicity, except Grade 3 nausea or emesis with maximum duration of 48 hrs on adequate medical therapy and Grade 3 diarrhea which persists for < 72 hrs in absence of maximal medical therapy; Grade ≥ 2 non hematologic treatment-emergent adverse event (TEAE) of potential clinical significance; treatment interruption ≥ 7 days due to unresolved toxicity; and any Grade 3 or 4 elevation in aspartate aminotransferase (AST) or alanine aminotransferase (ALT) associated with a Grade 2 elevation in bilirubin that is at least possibly related to alobresib.

Outcome measures

Measure	Monotherapy: Alobresib 0.6 mg n=2 Participants Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 0.6 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Monotherapy: Alobresib 1.4 mg n=1 Participants Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 1.4 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Monotherapy: Alobresib 2 mg n=1 Participants Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 2 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Monotherapy: Alobresib 3 mg n=7 Participants Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 3 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Monotherapy: Alobresib 4 mg n=6 Participants Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 4 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Monotherapy: Alobresib 6 mg n=4 Participants Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 6 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Combination Therapy: Alobresib 2 mg + Exemestane n=4 Participants Participants with advanced stage estrogen receptor positive breast cancer for whom no standard curative therapy existed, received alobresib tablets at a dose of 2 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle in combination with exemestane 25 mg tablets administered orally once daily on C1D1 of 28 days cycle.	Combination Therapy: Alobresib 2 mg + Fulvestrant n=3 Participants Participants with advanced stage estrogen receptor positive breast cancer for whom no standard curative therapy existed, received alobresib tablets at a dose of 2 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle in combination with fulvestrant 500 mg administered intramuscularly on C1D1 of 28 days cycle and every 28 days (± 3 days).	Combination Therapy: Alobresib 3 mg + Fulvestrant n=3 Participants Participants with advanced stage estrogen receptor positive breast cancer for whom no standard curative therapy existed, received alobresib tablets at a dose of 3 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle in combination with fulvestrant 500 mg administered intramuscularly on C1D1 of 28 days cycle and every 28 days (± 3 days).
Number of Participants Experiencing Dose Limiting Toxicities (DLTs)	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	2 Participants	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Cycle 1: Predose (0 hr), 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hrs postdose on Days 1 and 8 (1 Cycle = 28 days)

Population: Participants in the PK Analysis Set (included all enrolled participants who took at least 1 dose of study drug and had at least 1 nonmissing postdose value reported by the PK laboratory) with available data were analyzed.

Cmax is defined as the maximum concentration of the drug.

Outcome measures

Measure	Monotherapy: Alobresib 0.6 mg n=2 Participants Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 0.6 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Monotherapy: Alobresib 1.4 mg n=1 Participants Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 1.4 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Monotherapy: Alobresib 2 mg n=1 Participants Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 2 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Monotherapy: Alobresib 3 mg n=6 Participants Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 3 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Monotherapy: Alobresib 4 mg n=6 Participants Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 4 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Monotherapy: Alobresib 6 mg n=4 Participants Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 6 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Combination Therapy: Alobresib 2 mg + Exemestane n=4 Participants Participants with advanced stage estrogen receptor positive breast cancer for whom no standard curative therapy existed, received alobresib tablets at a dose of 2 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle in combination with exemestane 25 mg tablets administered orally once daily on C1D1 of 28 days cycle.	Combination Therapy: Alobresib 2 mg + Fulvestrant n=3 Participants Participants with advanced stage estrogen receptor positive breast cancer for whom no standard curative therapy existed, received alobresib tablets at a dose of 2 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle in combination with fulvestrant 500 mg administered intramuscularly on C1D1 of 28 days cycle and every 28 days (± 3 days).	Combination Therapy: Alobresib 3 mg + Fulvestrant n=3 Participants Participants with advanced stage estrogen receptor positive breast cancer for whom no standard curative therapy existed, received alobresib tablets at a dose of 3 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle in combination with fulvestrant 500 mg administered intramuscularly on C1D1 of 28 days cycle and every 28 days (± 3 days).
Pharmacokinetic (PK) Parameter: Cmax of Alobresib Cycle 1 Day 1	35.2 ng/mL Standard Deviation 7.21	59.1 ng/mL	141.0 ng/mL	197.5 ng/mL Standard Deviation 109.97	281.7 ng/mL Standard Deviation 98.78	376.2 ng/mL Standard Deviation 257.22	160.8 ng/mL Standard Deviation 7.93	149.7 ng/mL Standard Deviation 27.47	234.3 ng/mL Standard Deviation 70.49
Pharmacokinetic (PK) Parameter: Cmax of Alobresib Cycle 1 Day 8	64.0 ng/mL Standard Deviation 26.80	117.0 ng/mL	174.0 ng/mL	296.5 ng/mL Standard Deviation 199.49	407.2 ng/mL Standard Deviation 154.29	711.5 ng/mL Standard Deviation 350.84	193.0 ng/mL Standard Deviation 68.56	278.0 ng/mL Standard Deviation 95.69	458.7 ng/mL Standard Deviation 29.48

SECONDARY outcome

Timeframe: Cycle 1: Predose (0 hr), 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hrs postdose on Day 8 (1 Cycle = 28 days)

Population: Participants in the PK Analysis Set with available data were analyzed.

Ctau is defined as the observed drug concentration at the end of the dosing interval.

Outcome measures

Measure	Monotherapy: Alobresib 0.6 mg n=2 Participants Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 0.6 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Monotherapy: Alobresib 1.4 mg n=1 Participants Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 1.4 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Monotherapy: Alobresib 2 mg n=1 Participants Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 2 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Monotherapy: Alobresib 3 mg n=6 Participants Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 3 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Monotherapy: Alobresib 4 mg n=5 Participants Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 4 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Monotherapy: Alobresib 6 mg n=4 Participants Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 6 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Combination Therapy: Alobresib 2 mg + Exemestane n=4 Participants Participants with advanced stage estrogen receptor positive breast cancer for whom no standard curative therapy existed, received alobresib tablets at a dose of 2 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle in combination with exemestane 25 mg tablets administered orally once daily on C1D1 of 28 days cycle.	Combination Therapy: Alobresib 2 mg + Fulvestrant n=3 Participants Participants with advanced stage estrogen receptor positive breast cancer for whom no standard curative therapy existed, received alobresib tablets at a dose of 2 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle in combination with fulvestrant 500 mg administered intramuscularly on C1D1 of 28 days cycle and every 28 days (± 3 days).	Combination Therapy: Alobresib 3 mg + Fulvestrant n=3 Participants Participants with advanced stage estrogen receptor positive breast cancer for whom no standard curative therapy existed, received alobresib tablets at a dose of 3 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle in combination with fulvestrant 500 mg administered intramuscularly on C1D1 of 28 days cycle and every 28 days (± 3 days).
PK Parameter: Ctau of Alobresib	14.7 ng/mL Standard Deviation 0.28	60.7 ng/mL	34.4 ng/mL	131.0 ng/mL Standard Deviation 149.21	168.4 ng/mL Standard Deviation 165.71	237.1 ng/mL Standard Deviation 167.31	44.2 ng/mL Standard Deviation 21.62	59.4 ng/mL Standard Deviation 36.80	170.0 ng/mL Standard Deviation 39.00

SECONDARY outcome

Timeframe: Cycle 1: Predose (0 hr), 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hrs postdose on Days 1 and 8 (1 Cycle = 28 days)

Population: Participants in the PK Analysis Set with available data were analyzed.

AUC0-24 is defined as the concentration of drug over time from time zero to time 24 hrs.

Outcome measures

Measure	Monotherapy: Alobresib 0.6 mg n=2 Participants Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 0.6 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Monotherapy: Alobresib 1.4 mg n=1 Participants Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 1.4 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Monotherapy: Alobresib 2 mg n=1 Participants Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 2 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Monotherapy: Alobresib 3 mg n=6 Participants Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 3 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Monotherapy: Alobresib 4 mg n=6 Participants Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 4 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Monotherapy: Alobresib 6 mg n=4 Participants Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 6 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Combination Therapy: Alobresib 2 mg + Exemestane n=4 Participants Participants with advanced stage estrogen receptor positive breast cancer for whom no standard curative therapy existed, received alobresib tablets at a dose of 2 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle in combination with exemestane 25 mg tablets administered orally once daily on C1D1 of 28 days cycle.	Combination Therapy: Alobresib 2 mg + Fulvestrant n=3 Participants Participants with advanced stage estrogen receptor positive breast cancer for whom no standard curative therapy existed, received alobresib tablets at a dose of 2 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle in combination with fulvestrant 500 mg administered intramuscularly on C1D1 of 28 days cycle and every 28 days (± 3 days).	Combination Therapy: Alobresib 3 mg + Fulvestrant n=3 Participants Participants with advanced stage estrogen receptor positive breast cancer for whom no standard curative therapy existed, received alobresib tablets at a dose of 3 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle in combination with fulvestrant 500 mg administered intramuscularly on C1D1 of 28 days cycle and every 28 days (± 3 days).
PK Parameter: AUC0-24 of Alobresib Cycle 1 Day 1	699.5 h*ng/mL Standard Deviation 392.28	1896.1 h*ng/mL	1413.2 h*ng/mL	2336.1 h*ng/mL Standard Deviation 1125.80	2692.1 h*ng/mL Standard Deviation 834.79	6347.4 h*ng/mL Standard Deviation 4602.91	1549.0 h*ng/mL Standard Deviation 498.72	1900.9 h*ng/mL Standard Deviation 363.22	3038.5 h*ng/mL Standard Deviation 263.15
PK Parameter: AUC0-24 of Alobresib Cycle 1 Day 8	640.0 h*ng/mL Standard Deviation 101.99	1838.5 h*ng/mL	1603.3 h*ng/mL	4430.5 h*ng/mL Standard Deviation 3776.16	5584.5 h*ng/mL Standard Deviation 3121.02	9432.2 h*ng/mL Standard Deviation 6278.61	1752.6 h*ng/mL Standard Deviation 485.84	2525.7 h*ng/mL Standard Deviation 1091.23	5665.1 h*ng/mL Standard Deviation 596.00

SECONDARY outcome

Timeframe: Cycle 1: Predose (0 hr), 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hrs postdose on Day 8 (1 Cycle = 28 days)

Population: Participants in the PK Analysis Set with available data were analyzed.

AUCtau is defined as the concentration of drug over time (the area under the concentration verses time curve over the dosing interval).

Outcome measures

Measure	Monotherapy: Alobresib 0.6 mg n=2 Participants Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 0.6 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Monotherapy: Alobresib 1.4 mg n=1 Participants Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 1.4 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Monotherapy: Alobresib 2 mg n=1 Participants Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 2 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Monotherapy: Alobresib 3 mg n=6 Participants Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 3 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Monotherapy: Alobresib 4 mg n=4 Participants Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 4 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Monotherapy: Alobresib 6 mg n=4 Participants Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 6 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Combination Therapy: Alobresib 2 mg + Exemestane n=4 Participants Participants with advanced stage estrogen receptor positive breast cancer for whom no standard curative therapy existed, received alobresib tablets at a dose of 2 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle in combination with exemestane 25 mg tablets administered orally once daily on C1D1 of 28 days cycle.	Combination Therapy: Alobresib 2 mg + Fulvestrant n=3 Participants Participants with advanced stage estrogen receptor positive breast cancer for whom no standard curative therapy existed, received alobresib tablets at a dose of 2 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle in combination with fulvestrant 500 mg administered intramuscularly on C1D1 of 28 days cycle and every 28 days (± 3 days).	Combination Therapy: Alobresib 3 mg + Fulvestrant n=3 Participants Participants with advanced stage estrogen receptor positive breast cancer for whom no standard curative therapy existed, received alobresib tablets at a dose of 3 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle in combination with fulvestrant 500 mg administered intramuscularly on C1D1 of 28 days cycle and every 28 days (± 3 days).
PK Parameter: AUCtau of Alobresib	643.3 h*ng/mL Standard Deviation 109.40	1838.5 h*ng/mL	1591.8 h*ng/mL	4391.7 h*ng/mL Standard Deviation 3716.47	4128.5 h*ng/mL Standard Deviation 333.78	9373.8 h*ng/mL Standard Deviation 6220.97	1750.8 h*ng/mL Standard Deviation 478.46	2514.3 h*ng/mL Standard Deviation 1097.14	5644.0 h*ng/mL Standard Deviation 603.80

SECONDARY outcome

Timeframe: Cycle 1: Predose (0 hr), 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hrs postdose on Days 1 and 8 (1 Cycle = 28 days)

Population: Participants in the PK Analysis Set with available data were analyzed.

Tmax is defined as the time (observed time point) of Cmax.

Outcome measures

Measure	Monotherapy: Alobresib 0.6 mg n=2 Participants Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 0.6 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Monotherapy: Alobresib 1.4 mg n=1 Participants Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 1.4 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Monotherapy: Alobresib 2 mg n=1 Participants Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 2 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Monotherapy: Alobresib 3 mg n=6 Participants Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 3 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Monotherapy: Alobresib 4 mg n=6 Participants Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 4 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Monotherapy: Alobresib 6 mg n=4 Participants Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 6 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Combination Therapy: Alobresib 2 mg + Exemestane n=4 Participants Participants with advanced stage estrogen receptor positive breast cancer for whom no standard curative therapy existed, received alobresib tablets at a dose of 2 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle in combination with exemestane 25 mg tablets administered orally once daily on C1D1 of 28 days cycle.	Combination Therapy: Alobresib 2 mg + Fulvestrant n=3 Participants Participants with advanced stage estrogen receptor positive breast cancer for whom no standard curative therapy existed, received alobresib tablets at a dose of 2 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle in combination with fulvestrant 500 mg administered intramuscularly on C1D1 of 28 days cycle and every 28 days (± 3 days).	Combination Therapy: Alobresib 3 mg + Fulvestrant n=3 Participants Participants with advanced stage estrogen receptor positive breast cancer for whom no standard curative therapy existed, received alobresib tablets at a dose of 3 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle in combination with fulvestrant 500 mg administered intramuscularly on C1D1 of 28 days cycle and every 28 days (± 3 days).
PK Parameter: Tmax of Alobresib Cycle 1 Day 1	2.1 hour Interval 2.0 to 2.1	4.0 hour Interval 4.0 to 4.0	0.5 hour Interval 0.5 to 0.5	2.0 hour Interval 0.6 to 4.1	0.5 hour Interval 0.4 to 1.0	4.1 hour Interval 1.1 to 4.2	0.5 hour Interval 0.5 to 6.1	6.1 hour Interval 0.6 to 24.1	1.1 hour Interval 0.5 to 5.9
PK Parameter: Tmax of Alobresib Cycle 1 Day 8	1.3 hour Interval 0.6 to 2.1	0.6 hour Interval 0.6 to 0.6	0.5 hour Interval 0.5 to 0.5	1.0 hour Interval 0.4 to 4.0	0.9 hour Interval 0.5 to 2.1	0.8 hour Interval 0.5 to 2.0	0.5 hour Interval 0.5 to 0.6	0.5 hour Interval 0.5 to 0.6	0.5 hour Interval 0.4 to 1.0

SECONDARY outcome

Timeframe: Cycle 1: Predose (0 hr), 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hrs postdose on Days 1 and 8 (1 Cycle = 28 days)

Population: Participants in the PK Analysis Set with available data were analyzed.

t1/2 is defined as the estimate of the terminal elimination half-life of the drug. Due to short sampling period of the terminal elimination phase in these cohorts t1/2 values should be interpreted with caution.

Outcome measures

Measure	Monotherapy: Alobresib 0.6 mg n=2 Participants Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 0.6 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Monotherapy: Alobresib 1.4 mg n=1 Participants Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 1.4 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Monotherapy: Alobresib 2 mg n=1 Participants Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 2 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Monotherapy: Alobresib 3 mg n=6 Participants Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 3 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Monotherapy: Alobresib 4 mg n=4 Participants Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 4 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Monotherapy: Alobresib 6 mg n=4 Participants Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 6 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Combination Therapy: Alobresib 2 mg + Exemestane n=3 Participants Participants with advanced stage estrogen receptor positive breast cancer for whom no standard curative therapy existed, received alobresib tablets at a dose of 2 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle in combination with exemestane 25 mg tablets administered orally once daily on C1D1 of 28 days cycle.	Combination Therapy: Alobresib 2 mg + Fulvestrant n=3 Participants Participants with advanced stage estrogen receptor positive breast cancer for whom no standard curative therapy existed, received alobresib tablets at a dose of 2 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle in combination with fulvestrant 500 mg administered intramuscularly on C1D1 of 28 days cycle and every 28 days (± 3 days).	Combination Therapy: Alobresib 3 mg + Fulvestrant n=2 Participants Participants with advanced stage estrogen receptor positive breast cancer for whom no standard curative therapy existed, received alobresib tablets at a dose of 3 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle in combination with fulvestrant 500 mg administered intramuscularly on C1D1 of 28 days cycle and every 28 days (± 3 days).
PK Parameter: t1/2 of Alobresib Cycle 1 Day 1	16.6 hour Interval 11.1 to 22.0	35.3 hour Interval 35.3 to 35.3	15.8 hour Interval 15.8 to 15.8	20.2 hour Interval 9.9 to 35.1	19.2 hour Interval 7.2 to 26.6	21.1 hour Interval 7.4 to 34.9	13.5 hour Interval 10.1 to 14.2	23.4 hour Interval 16.1 to 30.7	15.2 hour Interval 14.7 to 15.8
PK Parameter: t1/2 of Alobresib Cycle 1 Day 8	13.7 hour Interval 13.1 to 14.4	28.7 hour Interval 28.7 to 28.7	15.9 hour Interval 15.9 to 15.9	16.8 hour Interval 10.6 to 27.8	16.1 hour Interval 10.5 to 22.8	17.8 hour Interval 8.4 to 18.8	14.0 hour Interval 11.4 to 23.8	22.0 hour Interval 11.4 to 33.9	22.3 hour Interval 20.0 to 24.5

Adverse Events

Monotherapy: Alobresib 0.6 mg

Serious events: 1 serious events

Other events: 2 other events

Deaths: 1 deaths

Monotherapy: Alobresib 1.4 mg

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Monotherapy: Alobresib 2 mg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Monotherapy: Alobresib 3 mg

Serious events: 3 serious events

Other events: 7 other events

Deaths: 1 deaths

Monotherapy: Alobresib 4 mg

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Monotherapy: Alobresib 6 mg

Serious events: 1 serious events

Other events: 4 other events

Deaths: 1 deaths

Combination Therapy: Alobresib 2 mg + Exemestane

Serious events: 0 serious events

Other events: 3 other events

Deaths: 1 deaths

Combination Therapy: Alobresib 2 mg + Fulvestrant

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Combination Therapy: Alobresib 3 mg + Fulvestrant

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Monotherapy: Alobresib 0.6 mg n=2 participants at risk Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 0.6 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Monotherapy: Alobresib 1.4 mg n=1 participants at risk Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 1.4 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Monotherapy: Alobresib 2 mg n=1 participants at risk Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 2 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Monotherapy: Alobresib 3 mg n=7 participants at risk Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 3 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Monotherapy: Alobresib 4 mg n=6 participants at risk Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 4 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Monotherapy: Alobresib 6 mg n=4 participants at risk Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 6 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Combination Therapy: Alobresib 2 mg + Exemestane n=4 participants at risk Participants with advanced stage estrogen receptor positive breast cancer for whom no standard curative therapy existed, received alobresib tablets at a dose of 2 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle in combination with exemestane 25 mg tablets administered orally once daily on C1D1 of 28 days cycle.	Combination Therapy: Alobresib 2 mg + Fulvestrant n=3 participants at risk Participants with advanced stage estrogen receptor positive breast cancer for whom no standard curative therapy existed, received alobresib tablets at a dose of 2 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle in combination with fulvestrant 500 mg administered intramuscularly on C1D1 of 28 days cycle and every 28 days (± 3 days).	Combination Therapy: Alobresib 3 mg + Fulvestrant n=3 participants at risk Participants with advanced stage estrogen receptor positive breast cancer for whom no standard curative therapy existed, received alobresib tablets at a dose of 3 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle in combination with fulvestrant 500 mg administered intramuscularly on C1D1 of 28 days cycle and every 28 days (± 3 days).
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	100.0% 1/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Cardiac disorders Atrioventricular block complete	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	14.3% 1/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Endocrine disorders Adrenal haemorrhage	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Constipation	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	14.3% 1/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 1/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
General disorders Pain	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
General disorders Pyrexia	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	100.0% 1/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Hepatobiliary disorders Cholangitis	50.0% 1/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Pyelonephritis acute	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	14.3% 1/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Sepsis	50.0% 1/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Vascular disorders Deep vein thrombosis	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.

Other adverse events

Measure	Monotherapy: Alobresib 0.6 mg n=2 participants at risk Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 0.6 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Monotherapy: Alobresib 1.4 mg n=1 participants at risk Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 1.4 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Monotherapy: Alobresib 2 mg n=1 participants at risk Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 2 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Monotherapy: Alobresib 3 mg n=7 participants at risk Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 3 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Monotherapy: Alobresib 4 mg n=6 participants at risk Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 4 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Monotherapy: Alobresib 6 mg n=4 participants at risk Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 6 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.	Combination Therapy: Alobresib 2 mg + Exemestane n=4 participants at risk Participants with advanced stage estrogen receptor positive breast cancer for whom no standard curative therapy existed, received alobresib tablets at a dose of 2 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle in combination with exemestane 25 mg tablets administered orally once daily on C1D1 of 28 days cycle.	Combination Therapy: Alobresib 2 mg + Fulvestrant n=3 participants at risk Participants with advanced stage estrogen receptor positive breast cancer for whom no standard curative therapy existed, received alobresib tablets at a dose of 2 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle in combination with fulvestrant 500 mg administered intramuscularly on C1D1 of 28 days cycle and every 28 days (± 3 days).	Combination Therapy: Alobresib 3 mg + Fulvestrant n=3 participants at risk Participants with advanced stage estrogen receptor positive breast cancer for whom no standard curative therapy existed, received alobresib tablets at a dose of 3 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle in combination with fulvestrant 500 mg administered intramuscularly on C1D1 of 28 days cycle and every 28 days (± 3 days).
Blood and lymphatic system disorders Anaemia	50.0% 1/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	14.3% 1/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 1/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	33.3% 1/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Neutropenia	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	33.3% 1/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Splenomegaly	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	100.0% 1/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	100.0% 1/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	14.3% 1/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	75.0% 3/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	33.3% 1/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Cardiac disorders Palpitations	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Cardiac disorders Tachycardia	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Eye disorders Cataract	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 1/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal distension	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 1/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	33.3% 1/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal pain	50.0% 1/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	57.1% 4/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	33.3% 1/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Ascites	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 1/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 1/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Constipation	50.0% 1/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	14.3% 1/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 1/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Diarrhoea	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 1/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	33.3% 1/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Dry mouth	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	14.3% 1/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Dyspepsia	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	14.3% 1/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Flatulence	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	14.3% 1/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Gastrointestinal sounds abnormal	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 1/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	28.6% 2/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Gingival pain	50.0% 1/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Nausea	50.0% 1/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	100.0% 1/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	42.9% 3/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 1/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 1/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	66.7% 2/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Vomiting	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	42.9% 3/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 1/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	33.3% 1/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
General disorders Catheter site pain	50.0% 1/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
General disorders Chest pain	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 1/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
General disorders Fatigue	50.0% 1/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	100.0% 1/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	28.6% 2/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	75.0% 3/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	33.3% 1/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	66.7% 2/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
General disorders Generalised oedema	50.0% 1/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
General disorders Ill-defined disorder	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
General disorders Injection site reaction	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	33.3% 1/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
General disorders Oedema peripheral	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	14.3% 1/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
General disorders Pyrexia	50.0% 1/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	14.3% 1/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	100.0% 1/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Bronchitis	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	33.3% 1/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Cellulitis	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Localised infection	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	33.3% 1/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Oral candidiasis	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Sepsis	50.0% 1/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Sinusitis	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 1/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Tinea cruris	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Upper respiratory tract infection	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	14.3% 1/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Urinary tract infection	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	14.3% 1/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Contusion	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	33.3% 1/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Face injury	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	33.3% 1/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Incision site pain	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	14.3% 1/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Stoma site haemorrhage	50.0% 1/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Wound	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 1/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	14.3% 1/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Investigations Aspartate aminotransferase increased	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	100.0% 1/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 1/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Investigations Blood bilirubin increased	50.0% 1/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Investigations Platelet count decreased	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	14.3% 1/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Decreased appetite	100.0% 2/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	28.6% 2/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	33.3% 1/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Dehydration	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	100.0% 1/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	14.3% 1/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 1/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	33.3% 1/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hypokalaemia	50.0% 1/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	100.0% 1/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	33.3% 1/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	33.3% 2/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	33.3% 1/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	100.0% 1/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	14.3% 1/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	33.3% 1/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	50.0% 1/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	33.3% 1/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	33.3% 1/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	14.3% 1/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	100.0% 1/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 1/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Nervous system disorders Dizziness	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	100.0% 1/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	14.3% 1/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 1/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Nervous system disorders Dysgeusia	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	14.3% 1/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	33.3% 2/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	50.0% 2/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	66.7% 2/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Nervous system disorders Hypoaesthesia	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	33.3% 1/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Nervous system disorders Presyncope	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	33.3% 1/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Nervous system disorders Somnolence	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 1/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Nervous system disorders Transient ischaemic attack	50.0% 1/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Psychiatric disorders Anxiety	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	33.3% 1/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Psychiatric disorders Depression	50.0% 1/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 1/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Psychiatric disorders Insomnia	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 1/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Renal and urinary disorders Acute kidney injury	50.0% 1/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Renal and urinary disorders Haematuria	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	14.3% 1/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Renal and urinary disorders Hydronephrosis	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	14.3% 1/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Renal and urinary disorders Urinary retention	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Reproductive system and breast disorders Breast tenderness	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	33.3% 1/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 1/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 1/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	33.3% 1/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	14.3% 1/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 1/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Lower respiratory tract congestion	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Pleural effusion	50.0% 1/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	14.3% 1/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 1/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	14.3% 1/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	28.6% 2/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	33.3% 1/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Nail ridging	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	14.3% 1/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	33.3% 1/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	66.7% 2/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	33.3% 1/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Swelling face	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	100.0% 1/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Vascular disorders Embolism	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	14.3% 1/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Vascular disorders Hot flush	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	33.3% 1/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.
Vascular disorders Hypotension	0.00% 0/2 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	66.7% 2/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • First dose date up to 30 days after last dose of study drug (up to approximately 60.3 weeks for monotherapy groups and 42 weeks for combination therapy groups) The Full Analysis Set included all participants who received at least 1 dose of study drug.

Additional Information

Gilead Clinical Study Information Center

Gilead Sciences

Phone: 1-833-445-3230 (GILEAD-0)

Email: GileadClinicalTrials@gilead.com

Results disclosure agreements

• Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or The study has been completed at all study sites for at least 2 years
• Publication restrictions are in place

Restriction type: OTHER