Trial Outcomes & Findings for ACP-196 (Acalabrutinib) in Combination With Pembrolizumab, for Treatment of Hematologic Malignancies (NCT NCT02362035)

NCT ID: NCT02362035

Last Updated: 2025-12-11

Results Overview

Treatment-emergent AEs were defined as those events that occurred on or after the first dose of study drug, through the treatment phase, and within 30 days following the last dose of study drug.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

161 participants

Primary outcome timeframe

104 weeks

Results posted on

2025-12-11

Participant Flow

For the ACE-LY-005 program, Study Terminated by Sponsor refers to the following: Patients receiving treatment benefits will continue to be provided with study medication in the Post Final Analysis Management of the trial. No further data collection for analysis and reporting will be completed after the final Analysis

Participant milestones

Participant milestones
Measure	Acalabrutinib + Pembrolizumab All participants in this study received both study drugs and were therefore analysed together as a single treatment arm. Participants receiving the different regimens were not analysed separately by regimen, as the study was designed to assess the safety of the combination study treatment. The study included N=161 participants who received both acalabrutinib and pembrolizumab and are summarized together (from First stage safety lead-in and Second stage expansion). Stage 3 (additional expansion in subjects with Myelofibrosis) was planned but not conducted.
Overall Study STARTED	161
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	161

Reasons for withdrawal

Reasons for withdrawal
Measure	Acalabrutinib + Pembrolizumab All participants in this study received both study drugs and were therefore analysed together as a single treatment arm. Participants receiving the different regimens were not analysed separately by regimen, as the study was designed to assess the safety of the combination study treatment. The study included N=161 participants who received both acalabrutinib and pembrolizumab and are summarized together (from First stage safety lead-in and Second stage expansion). Stage 3 (additional expansion in subjects with Myelofibrosis) was planned but not conducted.
Overall Study Death	67
Overall Study Lost to Follow-up	3
Overall Study Adverse Event	1
Overall Study Physician Decision	1
Overall Study Subject started another cancer therapy	10
Overall Study Study terminated by sponsor	45
Overall Study Decision by subject not related to AE/SAE	2
Overall Study Decision by PI not related to AE/SAE	1
Overall Study Disease progression	11
Overall Study Withdrawal by Subject	20

Baseline Characteristics

ACP-196 (Acalabrutinib) in Combination With Pembrolizumab, for Treatment of Hematologic Malignancies

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Acalabrutinib + Pembrolizumab n=161 Participants All participants in this study received both study drugs and were therefore analysed together as a single treatment arm. Participants receiving the different regimens were not analysed separately by regimen, as the study was designed to assess the safety of the combination study treatment. The study included N=161 participants who received both acalabrutinib and pembrolizumab and are summarized together (from First stage safety lead-in and Second stage expansion). Stage 3 (additional expansion in subjects with Myelofibrosis) was planned but not conducted.
Age, Continuous	62.4 Years STANDARD_DEVIATION 14.6 • n=237 Participants
Sex: Female, Male Female	63 Participants n=237 Participants
Sex: Female, Male Male	98 Participants n=237 Participants
Race/Ethnicity, Customized Hispanic or Latino	11 Participants n=237 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	148 Participants n=237 Participants
Race/Ethnicity, Customized Not Reported	9 Participants n=237 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=237 Participants
Race/Ethnicity, Customized Asian	4 Participants n=237 Participants
Race/Ethnicity, Customized Black or African American	5 Participants n=237 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	2 Participants n=237 Participants
Race/Ethnicity, Customized White	141 Participants n=237 Participants
Region of Enrollment USA	161 Participants n=237 Participants

PRIMARY outcome

Timeframe: 104 weeks

Population: All participants in this study received both study drugs and were therefore analyzed together as a single treatment arm. Participants receiving the different regimens were not analyzed separately by regimen, as the study was designed to assess the safety of the combination study treatment.

Treatment-emergent AEs were defined as those events that occurred on or after the first dose of study drug, through the treatment phase, and within 30 days following the last dose of study drug.

Outcome measures

Outcome measures
Measure	Acalabrutinib + Pembrolizumab n=161 Participants All participants in this study received both study drugs and were therefore analysed together as a single treatment arm. Participants receiving the different regimens were not analysed separately by regimen, as the study was designed to assess the safety of the combination study treatment. The study included N=161 participants who received both acalabrutinib and pembrolizumab and are summarized together (from First stage safety lead-in and Second stage expansion). Stage 3 (additional expansion in subjects with Myelofibrosis) was planned but not conducted.
Number of Participants With Treatment Emergent Adverse Events (AEs)	160 Number of participants

PRIMARY outcome

Timeframe: 104 weeks

Severity of AEs was graded using the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03

Outcome measures

Outcome measures
Measure	Acalabrutinib + Pembrolizumab n=161 Participants All participants in this study received both study drugs and were therefore analysed together as a single treatment arm. Participants receiving the different regimens were not analysed separately by regimen, as the study was designed to assess the safety of the combination study treatment. The study included N=161 participants who received both acalabrutinib and pembrolizumab and are summarized together (from First stage safety lead-in and Second stage expansion). Stage 3 (additional expansion in subjects with Myelofibrosis) was planned but not conducted.
Number of Participants With Grade 3-4 Adverse Events	105 Number of participants

PRIMARY outcome

Timeframe: 104 weeks

Number of participants with CTCAE Grade 5 (fatal) adverse events

Outcome measures

Outcome measures
Measure	Acalabrutinib + Pembrolizumab n=161 Participants All participants in this study received both study drugs and were therefore analysed together as a single treatment arm. Participants receiving the different regimens were not analysed separately by regimen, as the study was designed to assess the safety of the combination study treatment. The study included N=161 participants who received both acalabrutinib and pembrolizumab and are summarized together (from First stage safety lead-in and Second stage expansion). Stage 3 (additional expansion in subjects with Myelofibrosis) was planned but not conducted.
Number of Participants With Grade 5 Adverse Events	9 Number of participants

PRIMARY outcome

Timeframe: 104 weeks

Study drug-related AEs were those assessed by investigator as related to study treatment.

Outcome measures

Outcome measures
Measure	Acalabrutinib + Pembrolizumab n=161 Participants All participants in this study received both study drugs and were therefore analysed together as a single treatment arm. Participants receiving the different regimens were not analysed separately by regimen, as the study was designed to assess the safety of the combination study treatment. The study included N=161 participants who received both acalabrutinib and pembrolizumab and are summarized together (from First stage safety lead-in and Second stage expansion). Stage 3 (additional expansion in subjects with Myelofibrosis) was planned but not conducted.
Number of Participants With Any Study-Drug Related AE	142 Number of participants

PRIMARY outcome

Timeframe: 104 weeks

The severity of the AEs was assessed by NCI CTCAE Version 4.03 or higher. Drug-related AEs were those assessed by investigator as related to study treatment.

Outcome measures

Outcome measures
Measure	Acalabrutinib + Pembrolizumab n=161 Participants All participants in this study received both study drugs and were therefore analysed together as a single treatment arm. Participants receiving the different regimens were not analysed separately by regimen, as the study was designed to assess the safety of the combination study treatment. The study included N=161 participants who received both acalabrutinib and pembrolizumab and are summarized together (from First stage safety lead-in and Second stage expansion). Stage 3 (additional expansion in subjects with Myelofibrosis) was planned but not conducted.
Number of Participants With Grade 3-4 Study-Drug Related AE	66 Number of participants

PRIMARY outcome

Timeframe: 104 weeks

Grade 5 (fatal) AEs assessed by investigator as related to study treatment.

Outcome measures

Outcome measures
Measure	Acalabrutinib + Pembrolizumab n=161 Participants All participants in this study received both study drugs and were therefore analysed together as a single treatment arm. Participants receiving the different regimens were not analysed separately by regimen, as the study was designed to assess the safety of the combination study treatment. The study included N=161 participants who received both acalabrutinib and pembrolizumab and are summarized together (from First stage safety lead-in and Second stage expansion). Stage 3 (additional expansion in subjects with Myelofibrosis) was planned but not conducted.
Number of Participants With Grade 5 Study-Drug Related AE	3 Number of participants

PRIMARY outcome

Timeframe: 104 weeks

Serious AEs were those that resulted in death, were life-threatening, required or prolonged in-patient hospitalization, resulted in persistent or significant disability/incapacity, resulted in a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product, or were considered a significant medical event by the investigator based on medical judgment.

Outcome measures

Outcome measures
Measure	Acalabrutinib + Pembrolizumab n=161 Participants All participants in this study received both study drugs and were therefore analysed together as a single treatment arm. Participants receiving the different regimens were not analysed separately by regimen, as the study was designed to assess the safety of the combination study treatment. The study included N=161 participants who received both acalabrutinib and pembrolizumab and are summarized together (from First stage safety lead-in and Second stage expansion). Stage 3 (additional expansion in subjects with Myelofibrosis) was planned but not conducted.
Number of Participants With Any SAE	75 Number of participants

PRIMARY outcome

Timeframe: 104 weeks

Outcome measures

Outcome measures
Measure	Acalabrutinib + Pembrolizumab n=161 Participants All participants in this study received both study drugs and were therefore analysed together as a single treatment arm. Participants receiving the different regimens were not analysed separately by regimen, as the study was designed to assess the safety of the combination study treatment. The study included N=161 participants who received both acalabrutinib and pembrolizumab and are summarized together (from First stage safety lead-in and Second stage expansion). Stage 3 (additional expansion in subjects with Myelofibrosis) was planned but not conducted.
Number of Participants With Grade 3-4 Any SAE	64 Number of participants

PRIMARY outcome

Timeframe: 104 weeks

Grade 5 events were fatal events. Serious AEs were those that resulted in death, were life-threatening, required or prolonged in-patient hospitalization, resulted in persistent or significant disability/incapacity, resulted in a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product, or were considered a significant medical event by the investigator based on medical judgment.

Outcome measures

Outcome measures
Measure	Acalabrutinib + Pembrolizumab n=161 Participants All participants in this study received both study drugs and were therefore analysed together as a single treatment arm. Participants receiving the different regimens were not analysed separately by regimen, as the study was designed to assess the safety of the combination study treatment. The study included N=161 participants who received both acalabrutinib and pembrolizumab and are summarized together (from First stage safety lead-in and Second stage expansion). Stage 3 (additional expansion in subjects with Myelofibrosis) was planned but not conducted.
Number of Participants With Grade 5 Any SAE	9 Number of participants

PRIMARY outcome

Timeframe: 104 weeks

Outcome measures

Outcome measures
Measure	Acalabrutinib + Pembrolizumab n=161 Participants All participants in this study received both study drugs and were therefore analysed together as a single treatment arm. Participants receiving the different regimens were not analysed separately by regimen, as the study was designed to assess the safety of the combination study treatment. The study included N=161 participants who received both acalabrutinib and pembrolizumab and are summarized together (from First stage safety lead-in and Second stage expansion). Stage 3 (additional expansion in subjects with Myelofibrosis) was planned but not conducted.
Number of Participants With Any Study Drug-Related SAE	34 Number of participants

PRIMARY outcome

Timeframe: 104 weeks

Outcome measures

Outcome measures
Measure	Acalabrutinib + Pembrolizumab n=161 Participants All participants in this study received both study drugs and were therefore analysed together as a single treatment arm. Participants receiving the different regimens were not analysed separately by regimen, as the study was designed to assess the safety of the combination study treatment. The study included N=161 participants who received both acalabrutinib and pembrolizumab and are summarized together (from First stage safety lead-in and Second stage expansion). Stage 3 (additional expansion in subjects with Myelofibrosis) was planned but not conducted.
Number of Participants With Any Grade 3-4 Study Drug-Related SAE	30 Number of participants

PRIMARY outcome

Timeframe: 104 weeks

Grade 5 AEs were fatal events. Serious AEs were those that resulted in death, were life-threatening, required or prolonged in-patient hospitalization, resulted in persistent or significant disability/incapacity, resulted in a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product, or were considered a significant medical event by the investigator based on medical judgment. Drug-related AEs were those assessed by investigator as related to study treatment.

Outcome measures

Outcome measures
Measure	Acalabrutinib + Pembrolizumab n=161 Participants All participants in this study received both study drugs and were therefore analysed together as a single treatment arm. Participants receiving the different regimens were not analysed separately by regimen, as the study was designed to assess the safety of the combination study treatment. The study included N=161 participants who received both acalabrutinib and pembrolizumab and are summarized together (from First stage safety lead-in and Second stage expansion). Stage 3 (additional expansion in subjects with Myelofibrosis) was planned but not conducted.
Number of Participants With Any Grade 5 Study Drug-Related SAE	3 Number of participants

PRIMARY outcome

Timeframe: 104 weeks

AEs that discontinuation of study treatment, or a reduction in dosage, or a delay (temporary withholding) in treatment.

Outcome measures

Outcome measures
Measure	Acalabrutinib + Pembrolizumab n=161 Participants All participants in this study received both study drugs and were therefore analysed together as a single treatment arm. Participants receiving the different regimens were not analysed separately by regimen, as the study was designed to assess the safety of the combination study treatment. The study included N=161 participants who received both acalabrutinib and pembrolizumab and are summarized together (from First stage safety lead-in and Second stage expansion). Stage 3 (additional expansion in subjects with Myelofibrosis) was planned but not conducted.
Number of Participants With AE Leading to Study Drug Discontinuation, Modification or Delay	83 Number of participants

PRIMARY outcome

Timeframe: 104 weeks

An adverse event that resulted in the permanent discontinuation of study treatment in the study.

Outcome measures

Outcome measures
Measure	Acalabrutinib + Pembrolizumab n=161 Participants All participants in this study received both study drugs and were therefore analysed together as a single treatment arm. Participants receiving the different regimens were not analysed separately by regimen, as the study was designed to assess the safety of the combination study treatment. The study included N=161 participants who received both acalabrutinib and pembrolizumab and are summarized together (from First stage safety lead-in and Second stage expansion). Stage 3 (additional expansion in subjects with Myelofibrosis) was planned but not conducted.
Number of Participants With AE Leading to Study Drug Discontinuation	45 Number of participants

PRIMARY outcome

Timeframe: 104 weeks

An adverse event that caused a temporary withholding of study treatment.

Outcome measures

Outcome measures
Measure	Acalabrutinib + Pembrolizumab n=161 Participants All participants in this study received both study drugs and were therefore analysed together as a single treatment arm. Participants receiving the different regimens were not analysed separately by regimen, as the study was designed to assess the safety of the combination study treatment. The study included N=161 participants who received both acalabrutinib and pembrolizumab and are summarized together (from First stage safety lead-in and Second stage expansion). Stage 3 (additional expansion in subjects with Myelofibrosis) was planned but not conducted.
Number of Participants With AE Leading to Study Drug Delay	71 Number of participants

PRIMARY outcome

Timeframe: 104 weeks

An adverse event that resulted in a reduction in the dosage of study treatment for that participant.

Outcome measures

Outcome measures
Measure	Acalabrutinib + Pembrolizumab n=161 Participants All participants in this study received both study drugs and were therefore analysed together as a single treatment arm. Participants receiving the different regimens were not analysed separately by regimen, as the study was designed to assess the safety of the combination study treatment. The study included N=161 participants who received both acalabrutinib and pembrolizumab and are summarized together (from First stage safety lead-in and Second stage expansion). Stage 3 (additional expansion in subjects with Myelofibrosis) was planned but not conducted.
Number of Participants With AE Leading to Study Drug Modification	9 Number of participants

SECONDARY outcome

Timeframe: 104 weeks

The percentage of subjects who achieve a partial response or complete response

Outcome measures

Outcome measures
Measure	Acalabrutinib + Pembrolizumab n=161 Participants All participants in this study received both study drugs and were therefore analysed together as a single treatment arm. Participants receiving the different regimens were not analysed separately by regimen, as the study was designed to assess the safety of the combination study treatment. The study included N=161 participants who received both acalabrutinib and pembrolizumab and are summarized together (from First stage safety lead-in and Second stage expansion). Stage 3 (additional expansion in subjects with Myelofibrosis) was planned but not conducted.
Overall Response Rate	38.5 percent Interval 31.0 to 46.5

SECONDARY outcome

Timeframe: 104 weeks

The interval from the first documentation of response to the earlier of the first documentation of definitive disease progression or death from any cause

Outcome measures

Outcome measures
Measure	Acalabrutinib + Pembrolizumab n=161 Participants All participants in this study received both study drugs and were therefore analysed together as a single treatment arm. Participants receiving the different regimens were not analysed separately by regimen, as the study was designed to assess the safety of the combination study treatment. The study included N=161 participants who received both acalabrutinib and pembrolizumab and are summarized together (from First stage safety lead-in and Second stage expansion). Stage 3 (additional expansion in subjects with Myelofibrosis) was planned but not conducted.
Duration of Response	28.5 Months Interval 9.0 to 36.4

SECONDARY outcome

Timeframe: 104 weeks

The interval from the first dose date of acalabrutinib or pembrolizumab to the earlier of the first documentation of objective disease progression or death from any cause

Outcome measures

Outcome measures
Measure	Acalabrutinib + Pembrolizumab n=161 Participants All participants in this study received both study drugs and were therefore analysed together as a single treatment arm. Participants receiving the different regimens were not analysed separately by regimen, as the study was designed to assess the safety of the combination study treatment. The study included N=161 participants who received both acalabrutinib and pembrolizumab and are summarized together (from First stage safety lead-in and Second stage expansion). Stage 3 (additional expansion in subjects with Myelofibrosis) was planned but not conducted.
Progression-free Survival	4.7 Months Interval 3.3 to 6.9

SECONDARY outcome

Timeframe: 104 weeks

The time from the first dose date of acalabrutinib or pembrolizumab until date of death due to any cause

Outcome measures

Outcome measures
Measure	Acalabrutinib + Pembrolizumab n=161 Participants All participants in this study received both study drugs and were therefore analysed together as a single treatment arm. Participants receiving the different regimens were not analysed separately by regimen, as the study was designed to assess the safety of the combination study treatment. The study included N=161 participants who received both acalabrutinib and pembrolizumab and are summarized together (from First stage safety lead-in and Second stage expansion). Stage 3 (additional expansion in subjects with Myelofibrosis) was planned but not conducted.
Overall Survival	50.4 Months Interval 26.2 to NA= not estimable. The NA of the 95% upper bound was calculated from the median. Since the upper limit of the KM curve hadn't reached 50%, there is no estimate for the upper confidence limit on the median. Therefore it's NA = not estimable.

SECONDARY outcome

Timeframe: 104 weeks

The time from the first dose date of acalabrutinib or pembrolizumab to the start of the next treatment other than the study treatment

Outcome measures

Outcome measures
Measure	Acalabrutinib + Pembrolizumab n=161 Participants All participants in this study received both study drugs and were therefore analysed together as a single treatment arm. Participants receiving the different regimens were not analysed separately by regimen, as the study was designed to assess the safety of the combination study treatment. The study included N=161 participants who received both acalabrutinib and pembrolizumab and are summarized together (from First stage safety lead-in and Second stage expansion). Stage 3 (additional expansion in subjects with Myelofibrosis) was planned but not conducted.
Time to Next Treatment	21.1 Months Interval 10.5 to 34.7

Adverse Events

Acalabrutinib + Pembrolizumab

Serious events: 75 serious events

Other events: 157 other events

Deaths: 69 deaths

Serious adverse events

Serious adverse events
Measure	Acalabrutinib + Pembrolizumab n=161 participants at risk All participants in this study received both study drugs and were therefore analysed together as a single treatment arm. Participants receiving the different regimens were not analysed separately by regimen, as the study was designed to assess the safety of the combination study treatment. The study included N=161 participants who received both acalabrutinib and pembrolizumab and are summarized together (from First stage safety lead-in and Second stage expansion). Stage 3 (additional expansion in subjects with Myelofibrosis) was planned but not conducted.
Blood and lymphatic system disorders Anaemia	1.2% 2/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Blood and lymphatic system disorders Anaemia of malignant disease	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Blood and lymphatic system disorders Febrile neutropenia	1.2% 2/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Blood and lymphatic system disorders Hyperviscosity syndrome	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Blood and lymphatic system disorders Lymphadenitis	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Cardiac disorders Cardiac failure congestive	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Cardiac disorders Cardiogenic shock	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Cardiac disorders Pericardial effusion	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Ear and labyrinth disorders Vertigo	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Endocrine disorders Hypercalcaemia of malignancy	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Endocrine disorders Hypothyroidism	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Gastrointestinal disorders Abdominal pain	1.2% 2/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Gastrointestinal disorders Colitis	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Gastrointestinal disorders Enteritis	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Gastrointestinal disorders Gastric haemorrhage	0.62% 1/161 • Number of events 3 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Gastrointestinal disorders Gastritis	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Gastrointestinal disorders Gastrointestinal haemorrhage	1.9% 3/161 • Number of events 3 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Gastrointestinal disorders Large intestinal obstruction	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Gastrointestinal disorders Nausea	1.2% 2/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Gastrointestinal disorders Pancreatitis	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Gastrointestinal disorders Retroperitoneal mass	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	1.2% 2/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Gastrointestinal disorders Vomiting	1.2% 2/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
General disorders Non-cardiac chest pain	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
General disorders Pain	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
General disorders Pyrexia	1.2% 2/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
General disorders Systemic inflammatory response syndrome	1.2% 2/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Hepatobiliary disorders Drug-induced liver injury	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Immune system disorders Autoimmune disorder	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Immune system disorders Cytokine release syndrome	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Abdominal abscess	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Bacteraemia	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Bronchitis	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Cellulitis	0.62% 1/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Epiglottitis	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Herpes zoster	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Influenza	1.2% 2/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Meningitis bacterial	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Necrotising fasciitis	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Neutropenic sepsis	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Pneumocystis jirovecii pneumonia	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Pneumonia	5.6% 9/161 • Number of events 9 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Pneumonia mycoplasmal	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Sepsis	3.1% 5/161 • Number of events 5 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Septic shock	1.2% 2/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Staphylococcal bacteraemia	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Upper respiratory tract infection	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Injury, poisoning and procedural complications Fall	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Injury, poisoning and procedural complications Foot fracture	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Injury, poisoning and procedural complications Hip fracture	1.2% 2/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Injury, poisoning and procedural complications Limb injury	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Investigations Alanine aminotransferase increased	1.9% 3/161 • Number of events 3 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Investigations Aspartate aminotransferase increased	2.5% 4/161 • Number of events 4 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Investigations Lymphocyte count decreased	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Investigations Platelet count decreased	0.62% 1/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Metabolism and nutrition disorders Dehydration	1.9% 3/161 • Number of events 3 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Metabolism and nutrition disorders Hypercalcaemia	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Metabolism and nutrition disorders Hyponatraemia	1.9% 3/161 • Number of events 4 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Metabolism and nutrition disorders Lactic acidosis	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Metabolism and nutrition disorders Tumour lysis syndrome	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Musculoskeletal and connective tissue disorders Back pain	1.2% 2/161 • Number of events 3 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Musculoskeletal and connective tissue disorders Neck pain	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour flare	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Nervous system disorders Cervical cord compression	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Nervous system disorders Headache	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Nervous system disorders Hyponatraemic seizure	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Nervous system disorders Seizure	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Nervous system disorders Syncope	1.2% 2/161 • Number of events 3 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Psychiatric disorders Mental status changes	1.9% 3/161 • Number of events 3 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Renal and urinary disorders Acute kidney injury	2.5% 4/161 • Number of events 4 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Renal and urinary disorders Renal failure	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Renal and urinary disorders Tubulointerstitial nephritis	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	1.9% 3/161 • Number of events 3 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.5% 4/161 • Number of events 4 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Respiratory, thoracic and mediastinal disorders Pneumonitis	1.2% 2/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Skin and subcutaneous tissue disorders Skin necrosis	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Vascular disorders Deep vein thrombosis	1.2% 2/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Vascular disorders Hypotension	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Vascular disorders Orthostatic hypotension	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.

Other adverse events

Other adverse events
Measure	Acalabrutinib + Pembrolizumab n=161 participants at risk All participants in this study received both study drugs and were therefore analysed together as a single treatment arm. Participants receiving the different regimens were not analysed separately by regimen, as the study was designed to assess the safety of the combination study treatment. The study included N=161 participants who received both acalabrutinib and pembrolizumab and are summarized together (from First stage safety lead-in and Second stage expansion). Stage 3 (additional expansion in subjects with Myelofibrosis) was planned but not conducted.
Blood and lymphatic system disorders Anaemia	21.7% 35/161 • Number of events 56 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Blood and lymphatic system disorders Febrile neutropenia	2.5% 4/161 • Number of events 4 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Blood and lymphatic system disorders Increased tendency to bruise	0.62% 1/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Blood and lymphatic system disorders Iron deficiency anaemia	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Blood and lymphatic system disorders Leukopenia	1.9% 3/161 • Number of events 3 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Blood and lymphatic system disorders Lymph node pain	1.2% 2/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Blood and lymphatic system disorders Lymphadenopathy	1.2% 2/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Blood and lymphatic system disorders Lymphocytosis	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Blood and lymphatic system disorders Methaemoglobinaemia	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Blood and lymphatic system disorders Microcytic anaemia	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Blood and lymphatic system disorders Neutropenia	9.9% 16/161 • Number of events 27 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Blood and lymphatic system disorders Pancytopenia	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Blood and lymphatic system disorders Polycythaemia	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Blood and lymphatic system disorders Thrombocytopenia	5.6% 9/161 • Number of events 20 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Cardiac disorders Acute coronary syndrome	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Cardiac disorders Angina pectoris	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Cardiac disorders Atrial fibrillation	3.7% 6/161 • Number of events 9 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Cardiac disorders Atrial flutter	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Cardiac disorders Bradycardia	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Cardiac disorders Cardiac failure congestive	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Cardiac disorders Cardiomegaly	1.2% 2/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Cardiac disorders Extrasystoles	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Cardiac disorders Myocardial calcification	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Cardiac disorders Palpitations	1.9% 3/161 • Number of events 3 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Cardiac disorders Pericardial effusion	1.9% 3/161 • Number of events 3 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Cardiac disorders Pericarditis	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Cardiac disorders Sinus tachycardia	3.1% 5/161 • Number of events 6 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Cardiac disorders Supraventricular tachycardia	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Cardiac disorders Tachycardia	2.5% 4/161 • Number of events 5 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Cardiac disorders Ventricular tachycardia	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Ear and labyrinth disorders Deafness	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Ear and labyrinth disorders Deafness neurosensory	0.62% 1/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Ear and labyrinth disorders Ear congestion	1.9% 3/161 • Number of events 3 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Ear and labyrinth disorders Ear discomfort	1.2% 2/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Ear and labyrinth disorders Ear haemorrhage	1.2% 2/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Ear and labyrinth disorders Eustachian tube dysfunction	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Ear and labyrinth disorders Excessive cerumen production	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Ear and labyrinth disorders Hypoacusis	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Ear and labyrinth disorders Tinnitus	1.9% 3/161 • Number of events 3 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Ear and labyrinth disorders Vertigo	1.2% 2/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Endocrine disorders Hyperthyroidism	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Endocrine disorders Hypothyroidism	1.9% 3/161 • Number of events 3 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Endocrine disorders Inappropriate antidiuretic hormone secretion	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Eye disorders Borderline glaucoma	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Eye disorders Cataract	1.2% 2/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Eye disorders Chalazion	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Eye disorders Conjunctival haemorrhage	1.2% 2/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Eye disorders Dry eye	1.2% 2/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Eye disorders Eye pruritus	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Eye disorders Eyelid rash	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Eye disorders Lacrimation increased	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Eye disorders Macular degeneration	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Eye disorders Periorbital swelling	1.2% 2/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Eye disorders Vision blurred	3.7% 6/161 • Number of events 6 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Eye disorders Vitreous degeneration	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Gastrointestinal disorders Abdominal discomfort	2.5% 4/161 • Number of events 4 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Gastrointestinal disorders Abdominal distension	6.8% 11/161 • Number of events 17 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Gastrointestinal disorders Abdominal pain	8.1% 13/161 • Number of events 18 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Gastrointestinal disorders Abdominal pain lower	1.2% 2/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Gastrointestinal disorders Abdominal pain upper	6.2% 10/161 • Number of events 11 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Gastrointestinal disorders Anal fistula	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Gastrointestinal disorders Anal incontinence	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Gastrointestinal disorders Ascites	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Gastrointestinal disorders Change of bowel habit	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Gastrointestinal disorders Cheilitis	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Gastrointestinal disorders Colitis	1.2% 2/161 • Number of events 3 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Gastrointestinal disorders Colitis microscopic	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Gastrointestinal disorders Constipation	12.4% 20/161 • Number of events 21 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Gastrointestinal disorders Diarrhoea	45.3% 73/161 • Number of events 135 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Gastrointestinal disorders Dry mouth	3.7% 6/161 • Number of events 6 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Gastrointestinal disorders Duodenal ulcer	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Gastrointestinal disorders Dyspepsia	5.0% 8/161 • Number of events 9 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Gastrointestinal disorders Dysphagia	5.6% 9/161 • Number of events 9 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Gastrointestinal disorders Epigastric discomfort	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Gastrointestinal disorders Epiploic appendagitis	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Gastrointestinal disorders Flatulence	2.5% 4/161 • Number of events 4 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Gastrointestinal disorders Food poisoning	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Gastrointestinal disorders Frequent bowel movements	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Gastrointestinal disorders Gastric haemorrhage	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Gastrointestinal disorders Gastric ulcer	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Gastrointestinal disorders Gastrooesophageal reflux disease	1.9% 3/161 • Number of events 3 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Gastrointestinal disorders Gingival bleeding	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Gastrointestinal disorders Gingival discomfort	1.2% 2/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Gastrointestinal disorders Haematochezia	1.2% 2/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Gastrointestinal disorders Haemorrhoids	1.2% 2/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Gastrointestinal disorders Hyperaesthesia teeth	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Gastrointestinal disorders Impaired gastric emptying	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Gastrointestinal disorders Intestinal perforation	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Gastrointestinal disorders Lip swelling	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Gastrointestinal disorders Melaena	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Gastrointestinal disorders Mouth haemorrhage	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Gastrointestinal disorders Mouth ulceration	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Gastrointestinal disorders Nausea	26.7% 43/161 • Number of events 63 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Gastrointestinal disorders Oesophageal spasm	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Gastrointestinal disorders Oesophageal stenosis	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Gastrointestinal disorders Oesophagitis	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Gastrointestinal disorders Oral disorder	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Gastrointestinal disorders Oral pain	1.2% 2/161 • Number of events 3 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Gastrointestinal disorders Palatal disorder	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Gastrointestinal disorders Pancreatitis	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Gastrointestinal disorders Paraesthesia oral	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Gastrointestinal disorders Proctitis	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Gastrointestinal disorders Stomatitis	2.5% 4/161 • Number of events 7 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Gastrointestinal disorders Toothache	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Gastrointestinal disorders Vomiting	20.5% 33/161 • Number of events 45 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
General disorders Asthenia	7.5% 12/161 • Number of events 13 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
General disorders Axillary pain	1.2% 2/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
General disorders Catheter site pain	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
General disorders Chest discomfort	1.2% 2/161 • Number of events 3 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
General disorders Chills	8.1% 13/161 • Number of events 16 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
General disorders Drug withdrawal syndrome	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
General disorders Early satiety	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
General disorders Exercise tolerance decreased	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
General disorders Facial pain	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
General disorders Fatigue	35.4% 57/161 • Number of events 77 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
General disorders Feeling cold	2.5% 4/161 • Number of events 5 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
General disorders Gait disturbance	2.5% 4/161 • Number of events 4 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
General disorders Influenza like illness	1.9% 3/161 • Number of events 3 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
General disorders Infusion site reaction	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
General disorders Malaise	3.7% 6/161 • Number of events 6 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
General disorders Mucosal inflammation	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
General disorders Nodule	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
General disorders Non-cardiac chest pain	2.5% 4/161 • Number of events 5 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
General disorders Oedema	3.7% 6/161 • Number of events 7 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
General disorders Oedema peripheral	12.4% 20/161 • Number of events 24 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
General disorders Pain	3.1% 5/161 • Number of events 7 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
General disorders Peripheral swelling	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
General disorders Polyp	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
General disorders Pyrexia	17.4% 28/161 • Number of events 40 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
General disorders Swelling	0.62% 1/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
General disorders Swelling face	0.62% 1/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
General disorders Systemic inflammatory response syndrome	1.2% 2/161 • Number of events 3 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
General disorders Thirst	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
General disorders Ulcer	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Hepatobiliary disorders Autoimmune hepatitis	1.9% 3/161 • Number of events 3 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Immune system disorders Allergy to arthropod sting	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Immune system disorders Hypersensitivity	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Immune system disorders Hypogammaglobulinaemia	1.9% 3/161 • Number of events 3 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Immune system disorders Seasonal allergy	1.9% 3/161 • Number of events 3 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Acute sinusitis	1.2% 2/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Bronchitis	5.6% 9/161 • Number of events 10 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Candida infection	5.0% 8/161 • Number of events 8 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Cellulitis	1.2% 2/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Clostridium difficile infection	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Conjunctivitis	1.9% 3/161 • Number of events 3 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Cystitis	1.2% 2/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Diverticulitis	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Ear infection	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Epiglottitis	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Escherichia bacteraemia	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Eye infection	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Folliculitis	1.2% 2/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Fungal skin infection	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Gastroenteritis viral	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Gingival abscess	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Herpes simplex	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Herpes zoster	3.7% 6/161 • Number of events 8 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Histoplasmosis	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Histoplasmosis disseminated	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Infection	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Influenza	2.5% 4/161 • Number of events 5 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Labyrinthitis	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Localised infection	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Lower respiratory tract infection	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Lymphangitis	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Mucosal infection	0.62% 1/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Nasal herpes	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Nasopharyngitis	5.6% 9/161 • Number of events 12 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Nocardiosis	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Onychomycosis	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Oral candidiasis	1.9% 3/161 • Number of events 3 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Oral herpes	2.5% 4/161 • Number of events 4 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Otitis externa	1.9% 3/161 • Number of events 3 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Otitis media	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Pharyngitis	1.2% 2/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Pharyngitis streptococcal	1.2% 2/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Pneumonia	3.7% 6/161 • Number of events 7 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Pneumonia streptococcal	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Pyuria	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Rash pustular	1.2% 2/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Respiratory tract infection viral	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Rhinitis	1.2% 2/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Rhinovirus infection	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Root canal infection	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Sepsis	1.9% 3/161 • Number of events 3 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Sinusitis	6.8% 11/161 • Number of events 13 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Skin infection	0.62% 1/161 • Number of events 3 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Soft tissue infection	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Tooth abscess	0.62% 1/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Upper respiratory tract infection	16.1% 26/161 • Number of events 40 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Urinary tract infection	6.2% 10/161 • Number of events 13 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Viral infection	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Infections and infestations Vulvovaginal mycotic infection	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Injury, poisoning and procedural complications Animal bite	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Injury, poisoning and procedural complications Arthropod bite	1.9% 3/161 • Number of events 3 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Injury, poisoning and procedural complications Arthropod sting	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Injury, poisoning and procedural complications Contusion	11.2% 18/161 • Number of events 23 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Injury, poisoning and procedural complications Eye contusion	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Injury, poisoning and procedural complications Fall	6.2% 10/161 • Number of events 15 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Injury, poisoning and procedural complications Foreign body	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Injury, poisoning and procedural complications Humerus fracture	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Injury, poisoning and procedural complications Incision site complication	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Injury, poisoning and procedural complications Infusion related reaction	1.9% 3/161 • Number of events 4 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Injury, poisoning and procedural complications Joint injury	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Injury, poisoning and procedural complications Ligament sprain	1.2% 2/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Injury, poisoning and procedural complications Limb injury	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Injury, poisoning and procedural complications Lip injury	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Injury, poisoning and procedural complications Muscle contusion	1.2% 2/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Injury, poisoning and procedural complications Muscle strain	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Injury, poisoning and procedural complications Periorbital haemorrhage	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Injury, poisoning and procedural complications Post procedural diarrhoea	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Injury, poisoning and procedural complications Procedural pain	1.2% 2/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Injury, poisoning and procedural complications Procedural vomiting	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Injury, poisoning and procedural complications Rib fracture	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Injury, poisoning and procedural complications Skin abrasion	1.9% 3/161 • Number of events 3 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Injury, poisoning and procedural complications Skin injury	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Injury, poisoning and procedural complications Vaccination complication	0.62% 1/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Injury, poisoning and procedural complications Wrist fracture	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Investigations Alanine aminotransferase increased	13.0% 21/161 • Number of events 54 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Investigations Amylase increased	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Investigations Aspartate aminotransferase increased	11.2% 18/161 • Number of events 29 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Investigations Blood alkaline phosphatase increased	1.9% 3/161 • Number of events 4 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Investigations Blood bilirubin increased	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Investigations Blood creatinine increased	4.3% 7/161 • Number of events 11 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Investigations Blood immunoglobulin g decreased	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Investigations Blood lactate dehydrogenase increased	1.2% 2/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Investigations Blood thyroid stimulating hormone increased	1.9% 3/161 • Number of events 3 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Investigations Blood uric acid increased	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Investigations Heart rate irregular	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Investigations Immunoglobulins decreased	1.2% 2/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Investigations Influenza a virus test positive	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Investigations Lymphocyte count decreased	3.1% 5/161 • Number of events 7 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Investigations Neutrophil count decreased	2.5% 4/161 • Number of events 5 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Investigations Oxygen saturation decreased	1.2% 2/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Investigations Platelet count decreased	4.3% 7/161 • Number of events 11 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Investigations Protein total decreased	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Investigations Serum ferritin increased	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Investigations Tri-iodothyronine free decreased	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Investigations Weight decreased	5.6% 9/161 • Number of events 11 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Investigations Weight increased	1.2% 2/161 • Number of events 3 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Investigations White blood cell count decreased	2.5% 4/161 • Number of events 6 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Metabolism and nutrition disorders Cachexia	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Metabolism and nutrition disorders Decreased appetite	26.1% 42/161 • Number of events 50 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Metabolism and nutrition disorders Dehydration	8.1% 13/161 • Number of events 15 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Metabolism and nutrition disorders Fluid retention	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Metabolism and nutrition disorders Glucose tolerance impaired	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Metabolism and nutrition disorders Hypercalcaemia	2.5% 4/161 • Number of events 7 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Metabolism and nutrition disorders Hyperglycaemia	3.1% 5/161 • Number of events 7 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Metabolism and nutrition disorders Hyperkalaemia	1.9% 3/161 • Number of events 3 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Metabolism and nutrition disorders Hypernatraemia	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Metabolism and nutrition disorders Hyperphosphataemia	1.2% 2/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Metabolism and nutrition disorders Hyperuricaemia	4.3% 7/161 • Number of events 9 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Metabolism and nutrition disorders Hypoalbuminaemia	1.9% 3/161 • Number of events 3 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Metabolism and nutrition disorders Hypocalcaemia	2.5% 4/161 • Number of events 4 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Metabolism and nutrition disorders Hypoglycaemia	1.2% 2/161 • Number of events 3 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Metabolism and nutrition disorders Hypokalaemia	9.9% 16/161 • Number of events 25 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Metabolism and nutrition disorders Hypomagnesaemia	6.2% 10/161 • Number of events 13 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Metabolism and nutrition disorders Hyponatraemia	6.2% 10/161 • Number of events 14 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Metabolism and nutrition disorders Hypophosphataemia	2.5% 4/161 • Number of events 4 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Metabolism and nutrition disorders Hypovolaemia	0.62% 1/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Metabolism and nutrition disorders Increased appetite	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Metabolism and nutrition disorders Iron deficiency	1.9% 3/161 • Number of events 3 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Metabolism and nutrition disorders Lactic acidosis	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Metabolism and nutrition disorders Malnutrition	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Metabolism and nutrition disorders Vitamin d deficiency	1.2% 2/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Musculoskeletal and connective tissue disorders Arthralgia	11.8% 19/161 • Number of events 25 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Musculoskeletal and connective tissue disorders Arthritis	1.2% 2/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Musculoskeletal and connective tissue disorders Arthropathy	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Musculoskeletal and connective tissue disorders Back pain	13.0% 21/161 • Number of events 25 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Musculoskeletal and connective tissue disorders Bone pain	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Musculoskeletal and connective tissue disorders Bursitis	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Musculoskeletal and connective tissue disorders Coccydynia	1.2% 2/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Musculoskeletal and connective tissue disorders Flank pain	5.0% 8/161 • Number of events 8 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Musculoskeletal and connective tissue disorders Groin pain	1.9% 3/161 • Number of events 3 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Musculoskeletal and connective tissue disorders Joint stiffness	1.9% 3/161 • Number of events 3 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Musculoskeletal and connective tissue disorders Joint swelling	1.2% 2/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Musculoskeletal and connective tissue disorders Muscle spasms	8.1% 13/161 • Number of events 16 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Musculoskeletal and connective tissue disorders Muscle tightness	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Musculoskeletal and connective tissue disorders Muscular weakness	5.6% 9/161 • Number of events 10 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	3.1% 5/161 • Number of events 5 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	5.0% 8/161 • Number of events 11 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	1.9% 3/161 • Number of events 3 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Musculoskeletal and connective tissue disorders Myalgia	7.5% 12/161 • Number of events 13 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Musculoskeletal and connective tissue disorders Neck pain	3.1% 5/161 • Number of events 5 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Musculoskeletal and connective tissue disorders Osteopenia	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Musculoskeletal and connective tissue disorders Osteoporosis	1.2% 2/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Musculoskeletal and connective tissue disorders Pain in extremity	5.0% 8/161 • Number of events 11 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Musculoskeletal and connective tissue disorders Pain in jaw	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Musculoskeletal and connective tissue disorders Synovial cyst	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Musculoskeletal and connective tissue disorders Temporomandibular joint syndrome	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Musculoskeletal and connective tissue disorders Tendonitis	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Musculoskeletal and connective tissue disorders Tenosynovitis	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Musculoskeletal and connective tissue disorders Trigger finger	1.2% 2/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Musculoskeletal and connective tissue disorders Winged scapula	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acrochordon	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	3.1% 5/161 • Number of events 5 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic myelomonocytic leukaemia	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.62% 1/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	1.2% 2/161 • Number of events 3 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma in situ	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanocytic naevus	1.2% 2/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer recurrent	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour compression	0.62% 1/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	1.2% 2/161 • Number of events 3 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Nervous system disorders Ataxia	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Nervous system disorders Dizziness	19.9% 32/161 • Number of events 37 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Nervous system disorders Dizziness postural	1.2% 2/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Nervous system disorders Dysgeusia	1.9% 3/161 • Number of events 4 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Nervous system disorders Facial paralysis	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Nervous system disorders Head discomfort	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Nervous system disorders Headache	35.4% 57/161 • Number of events 71 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Nervous system disorders Hypoaesthesia	1.2% 2/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Nervous system disorders Lethargy	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Nervous system disorders Migraine	1.2% 2/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Nervous system disorders Neuralgia	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Nervous system disorders Neuropathy peripheral	6.2% 10/161 • Number of events 13 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Nervous system disorders Paraesthesia	3.1% 5/161 • Number of events 5 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Nervous system disorders Parkinsonism	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Nervous system disorders Peripheral motor neuropathy	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Nervous system disorders Peripheral sensory neuropathy	1.9% 3/161 • Number of events 3 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Nervous system disorders Presyncope	1.9% 3/161 • Number of events 3 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Nervous system disorders Sciatic nerve neuropathy	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Nervous system disorders Sciatica	1.2% 2/161 • Number of events 3 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Nervous system disorders Sinus headache	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Nervous system disorders Somnolence	2.5% 4/161 • Number of events 4 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Nervous system disorders Syncope	1.2% 2/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Nervous system disorders Taste disorder	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Nervous system disorders Vocal cord paralysis	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Psychiatric disorders Abnormal dreams	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Psychiatric disorders Agitation	1.2% 2/161 • Number of events 4 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Psychiatric disorders Alcoholism	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Psychiatric disorders Anxiety	3.7% 6/161 • Number of events 6 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Psychiatric disorders Confusional state	4.3% 7/161 • Number of events 7 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Psychiatric disorders Delirium	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Psychiatric disorders Depression	2.5% 4/161 • Number of events 4 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Psychiatric disorders Dyssomnia	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Psychiatric disorders Insomnia	12.4% 20/161 • Number of events 21 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Psychiatric disorders Mental status changes	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Psychiatric disorders Post-traumatic stress disorder	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Psychiatric disorders Restlessness	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Psychiatric disorders Sleep disorder	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Psychiatric disorders Stress	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Renal and urinary disorders Acute kidney injury	3.1% 5/161 • Number of events 5 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Renal and urinary disorders Bladder spasm	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Renal and urinary disorders Chronic kidney disease	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Renal and urinary disorders Dysuria	3.1% 5/161 • Number of events 5 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Renal and urinary disorders Haematuria	3.7% 6/161 • Number of events 6 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Renal and urinary disorders Hypertonic bladder	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Renal and urinary disorders Micturition urgency	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Renal and urinary disorders Nephritis	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Renal and urinary disorders Nocturia	1.9% 3/161 • Number of events 3 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Renal and urinary disorders Pollakiuria	1.9% 3/161 • Number of events 3 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Renal and urinary disorders Polyuria	1.2% 2/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Renal and urinary disorders Urinary incontinence	1.2% 2/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Renal and urinary disorders Urinary retention	1.9% 3/161 • Number of events 4 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Renal and urinary disorders Urinary tract obstruction	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Reproductive system and breast disorders Atrophic vulvovaginitis	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Reproductive system and breast disorders Erectile dysfunction	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Reproductive system and breast disorders Genital lesion	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Reproductive system and breast disorders Haematospermia	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Reproductive system and breast disorders Nipple pain	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Reproductive system and breast disorders Oedema genital	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Reproductive system and breast disorders Penile pain	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Reproductive system and breast disorders Prostatitis	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Reproductive system and breast disorders Vaginal haemorrhage	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Reproductive system and breast disorders Vulvovaginal pruritus	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Respiratory, thoracic and mediastinal disorders Bronchial secretion retention	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Respiratory, thoracic and mediastinal disorders Cough	27.3% 44/161 • Number of events 68 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Respiratory, thoracic and mediastinal disorders Dysphonia	3.7% 6/161 • Number of events 6 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Respiratory, thoracic and mediastinal disorders Dyspnoea	18.0% 29/161 • Number of events 34 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	3.7% 6/161 • Number of events 7 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Respiratory, thoracic and mediastinal disorders Epistaxis	5.0% 8/161 • Number of events 8 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Respiratory, thoracic and mediastinal disorders Laryngeal inflammation	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Respiratory, thoracic and mediastinal disorders Laryngeal oedema	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Respiratory, thoracic and mediastinal disorders Nasal congestion	7.5% 12/161 • Number of events 15 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Respiratory, thoracic and mediastinal disorders Nasal dryness	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	5.0% 8/161 • Number of events 8 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Respiratory, thoracic and mediastinal disorders Paranasal sinus discomfort	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Respiratory, thoracic and mediastinal disorders Paranasal sinus hypersecretion	1.2% 2/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Respiratory, thoracic and mediastinal disorders Pharyngeal disorder	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Respiratory, thoracic and mediastinal disorders Pharyngeal haemorrhage	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Respiratory, thoracic and mediastinal disorders Pleural effusion	3.1% 5/161 • Number of events 5 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Respiratory, thoracic and mediastinal disorders Pneumonitis	3.1% 5/161 • Number of events 5 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Respiratory, thoracic and mediastinal disorders Productive cough	2.5% 4/161 • Number of events 5 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.2% 2/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	1.2% 2/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	1.9% 3/161 • Number of events 4 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	3.1% 5/161 • Number of events 6 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Respiratory, thoracic and mediastinal disorders Sinus congestion	2.5% 4/161 • Number of events 5 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Respiratory, thoracic and mediastinal disorders Throat irritation	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Respiratory, thoracic and mediastinal disorders Tracheal oedema	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	4.3% 7/161 • Number of events 8 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Respiratory, thoracic and mediastinal disorders Wheezing	3.1% 5/161 • Number of events 5 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Skin and subcutaneous tissue disorders Actinic keratosis	1.2% 2/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Skin and subcutaneous tissue disorders Alopecia	5.0% 8/161 • Number of events 9 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Skin and subcutaneous tissue disorders Angioedema	0.62% 1/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Skin and subcutaneous tissue disorders Dandruff	0.62% 1/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Skin and subcutaneous tissue disorders Dermatitis	1.2% 2/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Skin and subcutaneous tissue disorders Dermatitis contact	1.9% 3/161 • Number of events 5 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Skin and subcutaneous tissue disorders Drug eruption	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Skin and subcutaneous tissue disorders Dry skin	5.0% 8/161 • Number of events 8 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Skin and subcutaneous tissue disorders Ecchymosis	1.9% 3/161 • Number of events 3 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Skin and subcutaneous tissue disorders Eczema	1.2% 2/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Skin and subcutaneous tissue disorders Erythema	3.1% 5/161 • Number of events 5 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Skin and subcutaneous tissue disorders Erythema multiforme	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Skin and subcutaneous tissue disorders Hyperhidrosis	3.1% 5/161 • Number of events 6 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Skin and subcutaneous tissue disorders Keloid scar	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Skin and subcutaneous tissue disorders Keratosis pilaris	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Skin and subcutaneous tissue disorders Night sweats	8.1% 13/161 • Number of events 14 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Skin and subcutaneous tissue disorders Onychoclasis	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Skin and subcutaneous tissue disorders Pain of skin	1.2% 2/161 • Number of events 3 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Skin and subcutaneous tissue disorders Papule	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Skin and subcutaneous tissue disorders Petechiae	4.3% 7/161 • Number of events 9 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Skin and subcutaneous tissue disorders Pruritus	8.7% 14/161 • Number of events 15 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Skin and subcutaneous tissue disorders Psoriasis	1.9% 3/161 • Number of events 3 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Skin and subcutaneous tissue disorders Purpura	1.9% 3/161 • Number of events 3 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Skin and subcutaneous tissue disorders Rash	13.7% 22/161 • Number of events 37 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Skin and subcutaneous tissue disorders Rash erythematous	2.5% 4/161 • Number of events 6 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Skin and subcutaneous tissue disorders Rash macular	1.2% 2/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Skin and subcutaneous tissue disorders Rash maculo-papular	5.6% 9/161 • Number of events 10 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Skin and subcutaneous tissue disorders Rash papular	1.2% 2/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Skin and subcutaneous tissue disorders Rash pruritic	1.9% 3/161 • Number of events 3 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Skin and subcutaneous tissue disorders Skin discolouration	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Skin and subcutaneous tissue disorders Skin lesion	3.1% 5/161 • Number of events 6 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Skin and subcutaneous tissue disorders Skin necrosis	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Skin and subcutaneous tissue disorders Skin plaque	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Skin and subcutaneous tissue disorders Skin sensitisation	1.2% 2/161 • Number of events 3 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Skin and subcutaneous tissue disorders Skin ulcer	1.2% 2/161 • Number of events 4 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Skin and subcutaneous tissue disorders Skin ulcer haemorrhage	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Skin and subcutaneous tissue disorders Urticaria papular	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Vascular disorders Aortic stenosis	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Vascular disorders Flushing	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Vascular disorders Haematoma	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Vascular disorders Hot flush	3.1% 5/161 • Number of events 5 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Vascular disorders Hypertension	5.0% 8/161 • Number of events 10 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Vascular disorders Hypotension	13.0% 21/161 • Number of events 23 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Vascular disorders Lymphoedema	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Vascular disorders Orthostatic hypotension	1.2% 2/161 • Number of events 2 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Vascular disorders Pallor	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Vascular disorders Thrombophlebitis superficial	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Vascular disorders Vasculitis	0.62% 1/161 • Number of events 1 • For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020). All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.

Additional Information

Global Clinical Lead

Acerta Pharma

Phone: 1-877-240-9479

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place