Trial Outcomes & Findings for A Study to Evaluate Rucaparib in Combination With Other Anticancer Agents in Participants With a Solid Tumor (SEASTAR) (NCT NCT03992131)

Last Updated: 2024-01-16

Results Overview

Objective response was defined as a documented and confirmed best overall response of complete response (CR) or partial response (PR) as assessed by the investigator. CR: Disappearance of all target and non-target lesions; any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \<10 millimeters (mm); and normalization of tumor marker level. PR: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

25 participants

Primary outcome timeframe

From the first dose of study drug until the date of documented response to treatment, assessed up to 2 years

Results posted on

2024-01-16

Participant Flow

The study was planned to be conducted in 2 phases: Phase 1b and Phase 2. Enrollment was terminated before Phase 1b was complete, due to Sponsor's decision to discontinue development of the combination of rucaparib and sacituzumab govitecan. Hence, Phase 2 portion of the study was not conducted.

Participant milestones

Participant milestones
Measure	Arm A1: Rucaparib 300 mg BID and Lucitanib 4 mg QD Participants received oral rucaparib 300 milligrams (mg) twice daily (BID) and oral lucitanib 4 mg once daily (QD) continuously in 28-day cycles.	Arm A2: Rucaparib 400 mg BID and Lucitanib 4 mg QD Participants received oral rucaparib 400 mg BID and oral lucitanib 4 mg QD continuously in 28-day cycles.	Arm A3: Rucaparib 400 mg BID and Lucitanib 6 mg QD Participants received oral rucaparib 400 mg BID and oral lucitanib 6 mg QD continuously in 28-day cycles.	Arm A4: Rucaparib 600 mg BID and Lucitanib 6 mg QD Participants received oral rucaparib 600 mg BID and oral lucitanib 6 mg QD continuously in 28-day cycles.	Arm B1: Rucaparib 300 mg BID and Sacituzumab Govitecan Participants received oral rucaparib 300 mg BID, administered continuously, in combination with intravenous (IV) sacituzumab govitecan 6 mg/kilogram (kg) administration on Day 1 and Day 8 of a 21-day cycle.	Arm B2: Rucaparib 300 mg QD and Sacituzumab Govitecan Participants received oral rucaparib 300 mg QD, administered continuously, in combination with IV sacituzumab govitecan 6 mg/kg administration on Day 1 and Day 8 of a 21-day cycle.
Overall Study STARTED	6	4	3	6	3	3
Overall Study Received at Least 1 Dose of Study Drug	6	4	3	6	3	3
Overall Study COMPLETED	6	4	3	6	3	3
Overall Study NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Evaluate Rucaparib in Combination With Other Anticancer Agents in Participants With a Solid Tumor (SEASTAR)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A1: Rucaparib 300 mg BID and Lucitanib 4 mg QD n=6 Participants Participants received oral rucaparib 300 mg BID and oral lucitanib 4 mg QD continuously in 28-day cycles.	Arm A2: Rucaparib 400 mg BID and Lucitanib 4 mg QD n=4 Participants Participants received oral rucaparib 400 mg BID and oral lucitanib 4 mg QD continuously in 28-day cycles.	Arm A3: Rucaparib 400 mg BID and Lucitanib 6 mg QD n=3 Participants Participants received oral rucaparib 400 mg BID and oral lucitanib 6 mg QD continuously in 28-day cycles.	Arm A4: Rucaparib 600 mg BID and Lucitanib 6 mg QD n=6 Participants Participants received oral rucaparib 600 mg BID and oral lucitanib 6 mg QD continuously in 28-day cycles.	Arm B1: Rucaparib 300 mg BID and Sacituzumab Govitecan n=3 Participants Participants received oral rucaparib 300 mg BID, administered continuously, in combination with IV sacituzumab govitecan 6 mg/kg administration on Day 1 and Day 8 of a 21-day cycle.	Arm B2: Rucaparib 300 mg QD and Sacituzumab Govitecan n=3 Participants Participants received oral rucaparib 300 mg QD, administered continuously, in combination with IV sacituzumab govitecan 6 mg/kg administration on Day 1 and Day 8 of a 21-day cycle.	Total n=25 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=99 Participants	3 Participants n=107 Participants	0 Participants n=206 Participants	6 Participants n=7 Participants	3 Participants n=31 Participants	2 Participants n=30 Participants	17 Participants n=3 Participants
Age, Categorical >=65 years	3 Participants n=99 Participants	1 Participants n=107 Participants	3 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	1 Participants n=30 Participants	8 Participants n=3 Participants
Sex: Female, Male Female	5 Participants n=99 Participants	2 Participants n=107 Participants	2 Participants n=206 Participants	5 Participants n=7 Participants	2 Participants n=31 Participants	3 Participants n=30 Participants	19 Participants n=3 Participants
Sex: Female, Male Male	1 Participants n=99 Participants	2 Participants n=107 Participants	1 Participants n=206 Participants	1 Participants n=7 Participants	1 Participants n=31 Participants	0 Participants n=30 Participants	6 Participants n=3 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants	2 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	3 Participants n=3 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=99 Participants	4 Participants n=107 Participants	2 Participants n=206 Participants	4 Participants n=7 Participants	3 Participants n=31 Participants	3 Participants n=30 Participants	21 Participants n=3 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	1 Participants n=3 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	1 Participants n=31 Participants	0 Participants n=30 Participants	1 Participants n=3 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants
Race (NIH/OMB) Black or African American	1 Participants n=99 Participants	1 Participants n=107 Participants	0 Participants n=206 Participants	1 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	3 Participants n=3 Participants
Race (NIH/OMB) White	5 Participants n=99 Participants	3 Participants n=107 Participants	2 Participants n=206 Participants	4 Participants n=7 Participants	2 Participants n=31 Participants	3 Participants n=30 Participants	19 Participants n=3 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants	1 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	2 Participants n=3 Participants

PRIMARY outcome

Timeframe: From the first dose of study drug until the date of documented response to treatment, assessed up to 2 years

Population: Due to Sponsor's decision to discontinue development of the combination of rucaparib and sacituzumab govitecan, the study was terminated before Phase 1b was complete, and Phase 2 portion of the study was not conducted. Hence, the data for this outcome measure could not be collected and analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the date of first best response to disease progression or death, whichever occurs first, assessed up to 2 years

Duration of response was measured from the date that best response (CR or PR) was first recorded until the first date that disease progression was documented per RECIST v1.1. CR: Disappearance of all target and non-target lesions; any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \<10 mm; and normalization of tumor marker level. PR: At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. Progressive disease: At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions was also considered progression.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the first dose of study drug to documented radiographic progression or death, whichever occurs first, assessed up to 2 years

PFS was measured as the 1+ the number of days from the first dose of study drug to documented radiographic progression, according to RECIST v1.1, as determined by the investigator, or death due to any cause, whichever occurred first. Progressive disease: At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions was also considered progression.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the first dose of study drug until the date of documented response to treatment, assessed up to 2 years

Population: Efficacy population included all participants who had received at least 1 dose of rucaparib or the second study drug and who had measurable disease per RECIST v1.1 at baseline.

Objective response was defined as a documented and confirmed best overall response of CR or PR as assessed by the investigator. CR: Disappearance of all target and non-target lesions; any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \<10 mm; and normalization of tumor marker level. PR: At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

Outcome measures

Outcome measures
Measure	Arm A1: Rucaparib 300 mg BID and Lucitanib 4 mg QD n=6 Participants Participants received oral rucaparib 300 mg BID and oral lucitanib 4 mg QD continuously in 28-day cycles.	Arm A2: Rucaparib 400 mg BID and Lucitanib 4 mg QD n=4 Participants Participants received oral rucaparib 400 mg BID and oral lucitanib 4 mg QD continuously in 28-day cycles.	Arm A3: Rucaparib 400 mg BID and Lucitanib 6 mg QD n=3 Participants Participants received oral rucaparib 400 mg BID and oral lucitanib 6 mg QD continuously in 28-day cycles.	Arm A4: Rucaparib 600 mg BID and Lucitanib 6 mg QD n=6 Participants Participants received oral rucaparib 600 mg BID and oral lucitanib 6 mg QD continuously in 28-day cycles.	Arm B1: Rucaparib 300 mg BID and Sacituzumab Govitecan n=3 Participants Participants received oral rucaparib 300 mg BID, administered continuously, in combination with IV sacituzumab govitecan 6 mg/kg administration on Day 1 and Day 8 of a 21-day cycle.	Arm B2: Rucaparib 300 mg QD and Sacituzumab Govitecan n=3 Participants Participants received oral rucaparib 300 mg QD, administered continuously, in combination with IV sacituzumab govitecan 6 mg/kg administration on Day 1 and Day 8 of a 21-day cycle.
Number of Participants With Objective Response, as Assessed by the Investigator Per RECIST v1.1 (Phase 1b)	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	2 Participants

Adverse Events

Arm A1: Rucaparib 300 mg BID and Lucitanib 4 mg QD

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

Arm A2: Rucaparib 400 mg BID and Lucitanib 4 mg QD

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Arm A3: Rucaparib 400 mg BID and Lucitanib 6 mg QD

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Arm A4: Rucaparib 600 mg BID and Lucitanib 6 mg QD

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Arm B1: Rucaparib 300 mg BID and Sacituzumab Govitecan

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Arm B2: Rucaparib 300 mg QD and Sacituzumab Govitecan

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm A1: Rucaparib 300 mg BID and Lucitanib 4 mg QD n=6 participants at risk Participants received oral rucaparib 300 mg BID and oral lucitanib 4 mg QD continuously in 28-day cycles.	Arm A2: Rucaparib 400 mg BID and Lucitanib 4 mg QD n=4 participants at risk Participants received oral rucaparib 400 mg BID and oral lucitanib 4 mg QD continuously in 28-day cycles.	Arm A3: Rucaparib 400 mg BID and Lucitanib 6 mg QD n=3 participants at risk Participants received oral rucaparib 400 mg BID and oral lucitanib 6 mg QD continuously in 28-day cycles.	Arm A4: Rucaparib 600 mg BID and Lucitanib 6 mg QD n=6 participants at risk Participants received oral rucaparib 600 mg BID and oral lucitanib 6 mg QD continuously in 28-day cycles.	Arm B1: Rucaparib 300 mg BID and Sacituzumab Govitecan n=3 participants at risk Participants received oral rucaparib 300 mg BID, administered continuously, in combination with IV sacituzumab govitecan 6 mg/kg administration on Day 1 and Day 8 of a 21-day cycle.	Arm B2: Rucaparib 300 mg QD and Sacituzumab Govitecan n=3 participants at risk Participants received oral rucaparib 300 mg QD, administered continuously, in combination with IV sacituzumab govitecan 6 mg/kg administration on Day 1 and Day 8 of a 21-day cycle.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Blood and lymphatic system disorders Anaemia	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Gastrointestinal disorders Constipation	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Infections and infestations Appendicitis	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Infections and infestations Cellulitis	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Investigations Alanine aminotransferase increased	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Investigations Aspartate aminotransferase increased	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Investigations Blood creatinine increased	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Renal and urinary disorders Hydronephrosis	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Hepatobiliary disorders Cholecystitis	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Infections and infestations Clostridium difficile infection	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.

Other adverse events

Other adverse events
Measure	Arm A1: Rucaparib 300 mg BID and Lucitanib 4 mg QD n=6 participants at risk Participants received oral rucaparib 300 mg BID and oral lucitanib 4 mg QD continuously in 28-day cycles.	Arm A2: Rucaparib 400 mg BID and Lucitanib 4 mg QD n=4 participants at risk Participants received oral rucaparib 400 mg BID and oral lucitanib 4 mg QD continuously in 28-day cycles.	Arm A3: Rucaparib 400 mg BID and Lucitanib 6 mg QD n=3 participants at risk Participants received oral rucaparib 400 mg BID and oral lucitanib 6 mg QD continuously in 28-day cycles.	Arm A4: Rucaparib 600 mg BID and Lucitanib 6 mg QD n=6 participants at risk Participants received oral rucaparib 600 mg BID and oral lucitanib 6 mg QD continuously in 28-day cycles.	Arm B1: Rucaparib 300 mg BID and Sacituzumab Govitecan n=3 participants at risk Participants received oral rucaparib 300 mg BID, administered continuously, in combination with IV sacituzumab govitecan 6 mg/kg administration on Day 1 and Day 8 of a 21-day cycle.	Arm B2: Rucaparib 300 mg QD and Sacituzumab Govitecan n=3 participants at risk Participants received oral rucaparib 300 mg QD, administered continuously, in combination with IV sacituzumab govitecan 6 mg/kg administration on Day 1 and Day 8 of a 21-day cycle.
Blood and lymphatic system disorders Anaemia	33.3% 2/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	50.0% 2/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	50.0% 3/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Blood and lymphatic system disorders Iron deficiency anaemia	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Blood and lymphatic system disorders Neutropenia	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	25.0% 1/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 2/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	66.7% 2/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	66.7% 2/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Ear and labyrinth disorders Ear pain	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Endocrine disorders Hypothyroidism	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	25.0% 1/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 2/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal distension	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal pain	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 2/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	66.7% 2/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal pain lower	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Gastrointestinal disorders Ascites	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Gastrointestinal disorders Constipation	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	25.0% 1/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	66.7% 2/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Gastrointestinal disorders Diarrhoea	33.3% 2/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	66.7% 2/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	100.0% 3/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Gastrointestinal disorders Gastrooesophageal reflux disease	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Gastrointestinal disorders Nausea	50.0% 3/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	50.0% 2/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	66.7% 2/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 2/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	66.7% 2/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Gastrointestinal disorders Toothache	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Gastrointestinal disorders Vomiting	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	66.7% 2/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
General disorders Asthenia	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
General disorders Axillary pain	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	25.0% 1/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
General disorders Catheter site erythema	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
General disorders Fatigue	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	25.0% 1/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	66.7% 2/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	66.7% 2/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
General disorders Mucosal inflammation	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
General disorders Nodule	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
General disorders Non-cardiac chest pain	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
General disorders Oedema peripheral	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
General disorders Swelling face	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	25.0% 1/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Infections and infestations COVID-19	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Infections and infestations Tooth infection	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Infections and infestations Upper respiratory tract infection	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Infections and infestations Urinary tract infection	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Injury, poisoning and procedural complications Ankle fracture	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Injury, poisoning and procedural complications Fall	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Investigations Alanine aminotransferase increased	50.0% 3/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	50.0% 2/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 2/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	66.7% 2/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	66.7% 2/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Investigations Aspartate aminotransferase increased	50.0% 3/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	50.0% 2/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 2/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Investigations Blood alkaline phosphatase increased	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 2/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Investigations Blood bilirubin increased	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Investigations Blood creatinine increased	33.3% 2/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	25.0% 1/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 2/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Investigations Blood lactate dehydrogenase increased	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Investigations Blood thyroid stimulating hormone increased	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Investigations Lymphocyte count decreased	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Investigations Neutrophil count decreased	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Investigations Platelet count decreased	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	25.0% 1/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 2/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Investigations Prostatic specific antigen increased	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Investigations Transaminases increased	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Investigations Urine output decreased	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Investigations Weight decreased	33.3% 2/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Investigations White blood cell count decreased	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	25.0% 1/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Metabolism and nutrition disorders Decreased appetite	33.3% 2/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 2/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Metabolism and nutrition disorders Dehydration	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	25.0% 1/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Metabolism and nutrition disorders Hypercholesterolaemia	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Metabolism and nutrition disorders Hyperkalaemia	33.3% 2/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Metabolism and nutrition disorders Hyperphosphataemia	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	25.0% 1/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Metabolism and nutrition disorders Hypokalaemia	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 2/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Metabolism and nutrition disorders Hypomagnesaemia	33.3% 2/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	25.0% 1/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Metabolism and nutrition disorders Hyponatraemia	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	66.7% 2/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	25.0% 1/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Metabolism and nutrition disorders Lactic acidosis	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 2/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	50.0% 2/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Muscle spasms	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Myalgia	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	25.0% 1/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Osteoporosis	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Nervous system disorders Dizziness	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Nervous system disorders Dysgeusia	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Nervous system disorders Headache	33.3% 2/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 2/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	25.0% 1/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Nervous system disorders Taste disorder	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Psychiatric disorders Anxiety	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Psychiatric disorders Insomnia	33.3% 2/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	25.0% 1/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Renal and urinary disorders Acute kidney injury	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Renal and urinary disorders Haematuria	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Renal and urinary disorders Proteinuria	50.0% 3/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 2/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Reproductive system and breast disorders Breast pain	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	25.0% 1/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Reproductive system and breast disorders Breast swelling	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	25.0% 1/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	33.3% 2/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	66.7% 2/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	25.0% 1/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	66.7% 2/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	16.7% 1/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	25.0% 1/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	66.7% 2/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Vascular disorders Flushing	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Vascular disorders Hypertension	50.0% 3/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	50.0% 2/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	66.7% 2/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	66.7% 4/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Blood and lymphatic system disorders Leukopenia	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Cardiac disorders Palpitations	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Gastrointestinal disorders Dysphagia	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Gastrointestinal disorders Proctalgia	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Gastrointestinal disorders Stomatitis	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
General disorders Influenza like illness	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
General disorders Swelling	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Immune system disorders Seasonal allergy	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Infections and infestations Eye infection	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Infections and infestations Oral candidiasis	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Infections and infestations Otitis media	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Infections and infestations Sinusitis	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Investigations Blood bicarbonate decreased	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Investigations Electrocardiogram abnormal	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Metabolism and nutrition disorders Vitamin D deficiency	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Metabolism and nutrition disorders Zinc deficiency	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Nervous system disorders Neuropathy peripheral	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Nervous system disorders Depression	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Reproductive system and breast disorders Breast tenderness	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Reproductive system and breast disorders Vulvovaginal dryness	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Rash	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.
Psychiatric disorders Depression	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/6 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	0.00% 0/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.	33.3% 1/3 • From the first dose of study drug up to 2 years Safety population included all participants who have received at least 1 dose of study drug.

Additional Information

Medical Information Department

pharmaand GmbH

Phone: +43/1/3560006

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor's agreements with investigators require proposed public disclosures of trial results to be submitted to Sponsor for review prior to publication. Sponsor may request deletion of confidential information or a delay in publication to address intellectual property concerns, but Sponsor may not suppress publication of the trial results indefinitely. Sponsor may request delay of a single-center publication until after the release of a multi-site publication or an agreed upon period of time.
Publication restrictions are in place

Restriction type: OTHER