Trial Outcomes & Findings for A Study Evaluating Safety, Pharmacokinetics, Pharmacodynamics, And Clinical Activity Of RO7119929 (TLR7 Agonist) In Participants With Unresectable Advanced Or Metastatic Hepatocellular Carcinoma, Biliary Tract Cancer, Or Solid Tumors With Hepatic Metastases (NCT NCT04338685)

Last Updated: 2024-12-09

Results Overview

A DLT is defined as a clinically significant AE (classified according to the National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] v.5.0) or significant laboratory abnormality 1) occurring during an assessment period of 21 days or 28 days after first dose of study treatment, respectively, and 2) is not attributed to disease progression, concomitant illness or another clearly identifiable cause.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

55 participants

Primary outcome timeframe

Baseline up to approximately 14 months

Results posted on

2024-12-09

Participant Flow

At Cycle 1 Day 1, Cycle 1 Day 8, and Cycle 1 Day 15, the participant were pre-medicated with 500 mL of crystalloid fluid and 500-1000 mg paracetamol orally (PO) or intravenously (IV) at the time of RO7119929 administration (± 30 minutes), followed by 500-1000 mg paracetamol PO or IV 4-6 hours after first drug administration. If no cytokine release syndrome (CRS) is observed, no further premedication was foreseen beyond Cycle 1.

Participant milestones

Participant milestones
Measure	Part A1-1 mg RO7119929 Participants received 1mg RO7119929 every week in 3-week cycles.	Part A1-3 mg RO7119929 Participants received 3 mg RO7119929 every week in 3-week cycles.	Part A1 -4 mg RO7119929 Participants received 4 mg RO7119929 every week in 3-week cycles	Part A1 - 6 mg RO7119929 Participants received 6 mg RO7119929 every week in 3-week cycles	Part A1 -9 mg RO7119929 Participants received 9 mg RO7119929 every week in 3-week cycles	Part B1-5 mg RO7119929 Participants with both available and evaluable tumor biopsy samples received 5 mg RO7119929 on Cycle 1 Day 1 to month 12	Part A2- 2/5/5 mg RO7119929 Participants received RO7119929 QW with step-up dosing of 2/5/5 mg during Cycle 1.	Part A2- 2/5/6 mg RO7119929 Participants received RO7119929 QW with step-up dosing of 2/5/6 mg during Cycle 1.	Part A3-4 mg RO7119929 Participants received tocilizumab pre-treatment on Cycle 1 Day 1, approximately 2 hours prior to RO7119929 administration and 4 mg RO7119929 every week in 3-week cycles
Overall Study STARTED	4	6	3	10	4	18	4	5	1
Overall Study COMPLETED	0	0	0	0	0	0	0	0	0
Overall Study NOT COMPLETED	4	6	3	10	4	18	4	5	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Part A1-1 mg RO7119929 Participants received 1mg RO7119929 every week in 3-week cycles.	Part A1-3 mg RO7119929 Participants received 3 mg RO7119929 every week in 3-week cycles.	Part A1 -4 mg RO7119929 Participants received 4 mg RO7119929 every week in 3-week cycles	Part A1 - 6 mg RO7119929 Participants received 6 mg RO7119929 every week in 3-week cycles	Part A1 -9 mg RO7119929 Participants received 9 mg RO7119929 every week in 3-week cycles	Part B1-5 mg RO7119929 Participants with both available and evaluable tumor biopsy samples received 5 mg RO7119929 on Cycle 1 Day 1 to month 12	Part A2- 2/5/5 mg RO7119929 Participants received RO7119929 QW with step-up dosing of 2/5/5 mg during Cycle 1.	Part A2- 2/5/6 mg RO7119929 Participants received RO7119929 QW with step-up dosing of 2/5/6 mg during Cycle 1.	Part A3-4 mg RO7119929 Participants received tocilizumab pre-treatment on Cycle 1 Day 1, approximately 2 hours prior to RO7119929 administration and 4 mg RO7119929 every week in 3-week cycles
Overall Study Death	3	4	2	4	4	8	1	0	0
Overall Study Study terminated by Sponsor	0	0	1	4	0	5	2	4	1
Overall Study Withdrawal by Subject	1	2	0	2	0	5	1	1	0

Baseline Characteristics

A Study Evaluating Safety, Pharmacokinetics, Pharmacodynamics, And Clinical Activity Of RO7119929 (TLR7 Agonist) In Participants With Unresectable Advanced Or Metastatic Hepatocellular Carcinoma, Biliary Tract Cancer, Or Solid Tumors With Hepatic Metastases

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A1-1 mg RO7119929 n=4 Participants Participants received 1mg RO7119929 every week in 3-week cycles.	Part A1-3 mg RO7119929 n=6 Participants Participants received 3 mg RO7119929 every week in 3-week cycles.	Part A1 -4 mg RO7119929 n=3 Participants Participants received 4 mg RO7119929 every week in 3-week cycles	Part A1 - 6 mg RO7119929 n=10 Participants Participants received 6 mg RO7119929 every week in 3-week cycles	Part A1 -9 mg RO7119929 n=4 Participants Participants received 9 mg RO7119929 every week in 3-week cycles	Part B1-5 mg RO7119929 n=18 Participants Participants with both available and evaluable tumor biopsy samples received 5 mg RO7119929 on Cycle 1 Day 1 to month 12	Part A2- 2/5/5 mg RO7119929 n=4 Participants Participants received RO7119929 QW with step-up dosing of 2/5/5 mg during Cycle 1.	Part A2- 2/5/6 mg RO7119929 n=5 Participants Participants received RO7119929 QW with step-up dosing of 2/5/6 mg during Cycle 1.	Part A3-4 mg RO7119929 n=1 Participants Participants received tocilizumab pre-treatment on Cycle 1 Day 1, approximately 2 hours prior to RO7119929 administration and 4 mg RO7119929 every week in 3-week cycles	Total n=55 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	6 Participants n=7 Participants	1 Participants n=5 Participants	7 Participants n=4 Participants	1 Participants n=21 Participants	14 Participants n=10 Participants	3 Participants n=115 Participants	5 Participants n=6 Participants	1 Participants n=6 Participants	41 Participants n=64 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	4 Participants n=10 Participants	1 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	14 Participants n=64 Participants
Age, Continuous	61.0 Years STANDARD_DEVIATION 5.0 • n=5 Participants	57.5 Years STANDARD_DEVIATION 5.0 • n=7 Participants	69.3 Years STANDARD_DEVIATION 10.8 • n=5 Participants	55.9 Years STANDARD_DEVIATION 12.6 • n=4 Participants	62.8 Years STANDARD_DEVIATION 16.0 • n=21 Participants	57.6 Years STANDARD_DEVIATION 9.8 • n=10 Participants	55.3 Years STANDARD_DEVIATION 10.7 • n=115 Participants	53.0 Years STANDARD_DEVIATION 10.3 • n=6 Participants	68.0 Years STANDARD_DEVIATION NA • n=6 Participants	58.1 Years STANDARD_DEVIATION 10.5 • n=64 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants	0 Participants n=21 Participants	14 Participants n=10 Participants	0 Participants n=115 Participants	1 Participants n=6 Participants	0 Participants n=6 Participants	23 Participants n=64 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants	4 Participants n=21 Participants	4 Participants n=10 Participants	4 Participants n=115 Participants	4 Participants n=6 Participants	1 Participants n=6 Participants	32 Participants n=64 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	10 Participants n=4 Participants	4 Participants n=21 Participants	18 Participants n=10 Participants	4 Participants n=115 Participants	5 Participants n=6 Participants	1 Participants n=6 Participants	55 Participants n=64 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	3 Participants n=21 Participants	7 Participants n=10 Participants	2 Participants n=115 Participants	3 Participants n=6 Participants	0 Participants n=6 Participants	28 Participants n=64 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	6 Participants n=4 Participants	1 Participants n=21 Participants	11 Participants n=10 Participants	2 Participants n=115 Participants	2 Participants n=6 Participants	1 Participants n=6 Participants	27 Participants n=64 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants

PRIMARY outcome

Timeframe: Baseline up to approximately 14 months

Outcome measures

Outcome measures
Measure	Part A1-1 mg RO7119929 n=4 Participants Participants received 1mg RO7119929 every week in 3-week cycles.	Part A1-3 mg RO7119929 n=6 Participants Participants received 3 mg RO7119929 every week in 3-week cycles.	Part A1 -4 mg RO7119929 n=3 Participants Participants received 4 mg RO7119929 every week in 3-week cycles	Part A1 - 6 mg RO7119929 n=10 Participants Participants received 6 mg RO7119929 every week in 3-week cycles	Part A1 -9 mg RO7119929 n=4 Participants Participants received 9 mg RO7119929 every week in 3-week cycles	Part B1-5 mg RO7119929 n=18 Participants Participants with both available and evaluable tumor biopsy samples received 5 mg RO7119929 on Cycle 1 Day 1 to month 12	Part A2- 2/5/5 mg RO7119929 n=4 Participants Participants received RO7119929 QW with step-up dosing of 2/5/5 mg during Cycle 1.	Part A2- 2/5/6 mg RO7119929 n=5 Participants Participants received RO7119929 QW with step-up dosing of 2/5/6 mg during Cycle 1.	Part A3-4 mg RO7119929 n=1 Participants Participants received tocilizumab pre-treatment on Cycle 1 Day 1, approximately 2 hours prior to RO7119929 administration and 4 mg RO7119929 every week in 3-week cycles
Number of Participants With Dose-Limiting Toxicities (DLT)	0 Participants	0 Participants	0 Participants	2 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline up to approximately 14 months

An Adverse Event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.

Outcome measures

Outcome measures
Measure	Part A1-1 mg RO7119929 n=4 Participants Participants received 1mg RO7119929 every week in 3-week cycles.	Part A1-3 mg RO7119929 n=6 Participants Participants received 3 mg RO7119929 every week in 3-week cycles.	Part A1 -4 mg RO7119929 n=3 Participants Participants received 4 mg RO7119929 every week in 3-week cycles	Part A1 - 6 mg RO7119929 n=10 Participants Participants received 6 mg RO7119929 every week in 3-week cycles	Part A1 -9 mg RO7119929 n=4 Participants Participants received 9 mg RO7119929 every week in 3-week cycles	Part B1-5 mg RO7119929 n=18 Participants Participants with both available and evaluable tumor biopsy samples received 5 mg RO7119929 on Cycle 1 Day 1 to month 12	Part A2- 2/5/5 mg RO7119929 n=4 Participants Participants received RO7119929 QW with step-up dosing of 2/5/5 mg during Cycle 1.	Part A2- 2/5/6 mg RO7119929 n=5 Participants Participants received RO7119929 QW with step-up dosing of 2/5/6 mg during Cycle 1.	Part A3-4 mg RO7119929 n=1 Participants Participants received tocilizumab pre-treatment on Cycle 1 Day 1, approximately 2 hours prior to RO7119929 administration and 4 mg RO7119929 every week in 3-week cycles
Number of Participants With Adverse Events (AEs) According To NCI CTCAE v5.0 Participants with Adverse Events	3 Participants	6 Participants	3 Participants	10 Participants	3 Participants	18 Participants	4 Participants	5 Participants	1 Participants
Number of Participants With Adverse Events (AEs) According To NCI CTCAE v5.0 Participants with Serious Adverse Events	1 Participants	2 Participants	2 Participants	4 Participants	4 Participants	11 Participants	1 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Cycle 1, after 1st dose, Cycle 2, after 4th dose (Each cycle is 21 days)

Population: Participants in 9 mg cohort were excluded from the Cycle 2 analysis (2 discontinued the study due to DLTs, the other 2 were re-dosed at 3 mg)

Outcome measures

Outcome measures
Measure	Part A1-1 mg RO7119929 n=4 Participants Participants received 1mg RO7119929 every week in 3-week cycles.	Part A1-3 mg RO7119929 n=6 Participants Participants received 3 mg RO7119929 every week in 3-week cycles.	Part A1 -4 mg RO7119929 n=3 Participants Participants received 4 mg RO7119929 every week in 3-week cycles	Part A1 - 6 mg RO7119929 n=10 Participants Participants received 6 mg RO7119929 every week in 3-week cycles	Part A1 -9 mg RO7119929 n=4 Participants Participants received 9 mg RO7119929 every week in 3-week cycles	Part B1-5 mg RO7119929 n=18 Participants Participants with both available and evaluable tumor biopsy samples received 5 mg RO7119929 on Cycle 1 Day 1 to month 12	Part A2- 2/5/5 mg RO7119929 Participants received RO7119929 QW with step-up dosing of 2/5/5 mg during Cycle 1.	Part A2- 2/5/6 mg RO7119929 Participants received RO7119929 QW with step-up dosing of 2/5/6 mg during Cycle 1.	Part A3-4 mg RO7119929 Participants received tocilizumab pre-treatment on Cycle 1 Day 1, approximately 2 hours prior to RO7119929 administration and 4 mg RO7119929 every week in 3-week cycles
Maximum Concentration (Cmax) for RO7119929 Following Administration of RO7119929 Cycle 1, after 1st dose (Prodrug)	1.29 ng/m Geometric Coefficient of Variation 146	1.94 ng/m Geometric Coefficient of Variation 46.8	1.85 ng/m Geometric Coefficient of Variation 62.1	2.34 ng/m Geometric Coefficient of Variation 90.6	3.67 ng/m Geometric Coefficient of Variation 178	3.18 ng/m Geometric Coefficient of Variation 204	—	—	—
Maximum Concentration (Cmax) for RO7119929 Following Administration of RO7119929 Cycle 2, after 4th dose (Active Drug)	7.28 ng/m Geometric Coefficient of Variation 40.5	26.3 ng/m Geometric Coefficient of Variation 52.8	30.7 ng/m Geometric Coefficient of Variation 26.8	44.7 ng/m Geometric Coefficient of Variation 92.7	—	50.2 ng/m Geometric Coefficient of Variation 32.7	—	—	—
Maximum Concentration (Cmax) for RO7119929 Following Administration of RO7119929 Cycle 1, after 1st dose (Active Drug)	7.35 ng/m Geometric Coefficient of Variation 37.4	25.1 ng/m Geometric Coefficient of Variation 49.0	39.7 ng/m Geometric Coefficient of Variation 7.89	48.4 ng/m Geometric Coefficient of Variation 64.0	60.9 ng/m Geometric Coefficient of Variation 16.3	49.9 ng/m Geometric Coefficient of Variation 40.2	—	—	—
Maximum Concentration (Cmax) for RO7119929 Following Administration of RO7119929 Cycle 2, after 4th dose (Prodrug)	1.46 ng/m Geometric Coefficient of Variation 231	2.49 ng/m Geometric Coefficient of Variation 21.4	2.01 ng/m Geometric Coefficient of Variation 34.6	2.77 ng/m Geometric Coefficient of Variation 54.9	—	4.30 ng/m Geometric Coefficient of Variation 299	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 15, Cycle 2 Day 1 (Cycle duration is 21 days)

Outcome measures

Outcome measures
Measure	Part A1-1 mg RO7119929 n=4 Participants Participants received 1mg RO7119929 every week in 3-week cycles.	Part A1-3 mg RO7119929 n=3 Participants Participants received 3 mg RO7119929 every week in 3-week cycles.	Part A1 -4 mg RO7119929 Participants received 4 mg RO7119929 every week in 3-week cycles	Part A1 - 6 mg RO7119929 Participants received 6 mg RO7119929 every week in 3-week cycles	Part A1 -9 mg RO7119929 Participants received 9 mg RO7119929 every week in 3-week cycles	Part B1-5 mg RO7119929 Participants with both available and evaluable tumor biopsy samples received 5 mg RO7119929 on Cycle 1 Day 1 to month 12	Part A2- 2/5/5 mg RO7119929 Participants received RO7119929 QW with step-up dosing of 2/5/5 mg during Cycle 1.	Part A2- 2/5/6 mg RO7119929 Participants received RO7119929 QW with step-up dosing of 2/5/6 mg during Cycle 1.	Part A3-4 mg RO7119929 Participants received tocilizumab pre-treatment on Cycle 1 Day 1, approximately 2 hours prior to RO7119929 administration and 4 mg RO7119929 every week in 3-week cycles
Maximum Concentration (Cmax) for RO7119929 Following Administration of RO7119929, Oral Step-Up Dose Prodrug: Cycle 1 Day 15	3.49 ng/mL Geometric Coefficient of Variation 116	1.97 ng/mL Geometric Coefficient of Variation 181	—	—	—	—	—	—	—
Maximum Concentration (Cmax) for RO7119929 Following Administration of RO7119929, Oral Step-Up Dose Prodrug: Cycle 2 Day 1	2.37 ng/mL Geometric Coefficient of Variation 48.9	3.58 ng/mL Geometric Coefficient of Variation 156	—	—	—	—	—	—	—
Maximum Concentration (Cmax) for RO7119929 Following Administration of RO7119929, Oral Step-Up Dose Active Drug: Cycle 1 Day 15	41.1 ng/mL Geometric Coefficient of Variation 54.9	39.6 ng/mL Geometric Coefficient of Variation 16.3	—	—	—	—	—	—	—
Maximum Concentration (Cmax) for RO7119929 Following Administration of RO7119929, Oral Step-Up Dose Active Drug: Cycle 2 Day 1	35.9 ng/mL Geometric Coefficient of Variation 52.3	44.4 ng/mL Geometric Coefficient of Variation 32.7	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1, after 1st dose, Cycle 2, after 4th dose (Each cycle is 21 days)

Population: Participants in 9 mg cohort were excluded from the Cycle 2 analysis (2 discontinued the study due to DLTs, the other 2 were re-dosed at 3 mg)

Outcome measures

Outcome measures
Measure	Part A1-1 mg RO7119929 n=4 Participants Participants received 1mg RO7119929 every week in 3-week cycles.	Part A1-3 mg RO7119929 n=6 Participants Participants received 3 mg RO7119929 every week in 3-week cycles.	Part A1 -4 mg RO7119929 n=3 Participants Participants received 4 mg RO7119929 every week in 3-week cycles	Part A1 - 6 mg RO7119929 n=10 Participants Participants received 6 mg RO7119929 every week in 3-week cycles	Part A1 -9 mg RO7119929 n=4 Participants Participants received 9 mg RO7119929 every week in 3-week cycles	Part B1-5 mg RO7119929 n=18 Participants Participants with both available and evaluable tumor biopsy samples received 5 mg RO7119929 on Cycle 1 Day 1 to month 12	Part A2- 2/5/5 mg RO7119929 Participants received RO7119929 QW with step-up dosing of 2/5/5 mg during Cycle 1.	Part A2- 2/5/6 mg RO7119929 Participants received RO7119929 QW with step-up dosing of 2/5/6 mg during Cycle 1.	Part A3-4 mg RO7119929 Participants received tocilizumab pre-treatment on Cycle 1 Day 1, approximately 2 hours prior to RO7119929 administration and 4 mg RO7119929 every week in 3-week cycles
Time of Maximum Concentration Observed (Tmax) for RO7119929 Following Administration of RO7119929 Cycle 1, after 1st dose (Active Drug)	2.14 hour Interval 1.03 to 4.22	2.07 hour Interval 1.43 to 5.03	1.52 hour Interval 1.02 to 1.53	2.00 hour Interval 0.97 to 4.03	1.83 hour Interval 1.52 to 2.15	3.01 hour Interval 1.0 to 6.5	—	—	—
Time of Maximum Concentration Observed (Tmax) for RO7119929 Following Administration of RO7119929 Cycle 1, after 1st dose (Prodrug)	1.02 hour Interval 0.48 to 4.22	1.50 hour Interval 0.47 to 4.02	1.02 hour Interval 0.53 to 1.08	1.53 hour Interval 0.5 to 3.17	1.28 hour Interval 0.5 to 2.15	1.54 hour Interval 0.52 to 4.07	—	—	—
Time of Maximum Concentration Observed (Tmax) for RO7119929 Following Administration of RO7119929 Cycle 2, after 4th dose (Prodrug)	1.03 hour Interval 0.33 to 3.03	0.79 hour Interval 0.25 to 2.83	1.53 hour Interval 0.53 to 4.03	1.08 hour Interval 0.55 to 3.07	—	1.17 hour Interval 0.53 to 4.02	—	—	—
Time of Maximum Concentration Observed (Tmax) for RO7119929 Following Administration of RO7119929 Cycle 2, after 4th dose (Active Drug)	2.28 hour Interval 1.03 to 3.75	1.74 hour Interval 1.17 to 4.12	1.53 hour Interval 1.08 to 4.03	1.55 hour Interval 1.08 to 5.85	—	2.17 hour Interval 1.5 to 4.13	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 15, Cycle 2 Day 1 (Cycle duration is 21 days)

Outcome measures

Outcome measures
Measure	Part A1-1 mg RO7119929 n=4 Participants Participants received 1mg RO7119929 every week in 3-week cycles.	Part A1-3 mg RO7119929 n=3 Participants Participants received 3 mg RO7119929 every week in 3-week cycles.	Part A1 -4 mg RO7119929 Participants received 4 mg RO7119929 every week in 3-week cycles	Part A1 - 6 mg RO7119929 Participants received 6 mg RO7119929 every week in 3-week cycles	Part A1 -9 mg RO7119929 Participants received 9 mg RO7119929 every week in 3-week cycles	Part B1-5 mg RO7119929 Participants with both available and evaluable tumor biopsy samples received 5 mg RO7119929 on Cycle 1 Day 1 to month 12	Part A2- 2/5/5 mg RO7119929 Participants received RO7119929 QW with step-up dosing of 2/5/5 mg during Cycle 1.	Part A2- 2/5/6 mg RO7119929 Participants received RO7119929 QW with step-up dosing of 2/5/6 mg during Cycle 1.	Part A3-4 mg RO7119929 Participants received tocilizumab pre-treatment on Cycle 1 Day 1, approximately 2 hours prior to RO7119929 administration and 4 mg RO7119929 every week in 3-week cycles
Time of Maximum Concentration Observed (Tmax) for RO7119929 Following Administration of RO7119929, Oral Step-Up Dose Prodrug: Cycle 1 Day 15	0.51 hours Interval 0.25 to 0.98	1.02 hours Interval 0.5 to 2.08	—	—	—	—	—	—	—
Time of Maximum Concentration Observed (Tmax) for RO7119929 Following Administration of RO7119929, Oral Step-Up Dose Prodrug: Cycle 2 Day 1	0.78 hours Interval 0.42 to 2.07	2.35 hours Interval 1.45 to 3.05	—	—	—	—	—	—	—
Time of Maximum Concentration Observed (Tmax) for RO7119929 Following Administration of RO7119929, Oral Step-Up Dose Active Drug: Cycle 1 Day 15	1.03 hours Interval 0.85 to 1.5	1.98 hours Interval 1.3 to 3.22	—	—	—	—	—	—	—
Time of Maximum Concentration Observed (Tmax) for RO7119929 Following Administration of RO7119929, Oral Step-Up Dose Active Drug: Cycle 2 Day 1	1.43 hours Interval 1.0 to 2.07	2.35 hours Interval 1.98 to 3.05	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1, after 1st dose, Cycle 2, after 4th dose (Each cycle is 21 days)

Population: Participants in 9 mg cohort were excluded from the Cycle 2 analysis (2 discontinued the study due to DLTs, the other 2 were re-dosed at 3 mg)

Outcome measures

Outcome measures
Measure	Part A1-1 mg RO7119929 n=4 Participants Participants received 1mg RO7119929 every week in 3-week cycles.	Part A1-3 mg RO7119929 n=6 Participants Participants received 3 mg RO7119929 every week in 3-week cycles.	Part A1 -4 mg RO7119929 n=3 Participants Participants received 4 mg RO7119929 every week in 3-week cycles	Part A1 - 6 mg RO7119929 n=10 Participants Participants received 6 mg RO7119929 every week in 3-week cycles	Part A1 -9 mg RO7119929 n=4 Participants Participants received 9 mg RO7119929 every week in 3-week cycles	Part B1-5 mg RO7119929 n=18 Participants Participants with both available and evaluable tumor biopsy samples received 5 mg RO7119929 on Cycle 1 Day 1 to month 12	Part A2- 2/5/5 mg RO7119929 Participants received RO7119929 QW with step-up dosing of 2/5/5 mg during Cycle 1.	Part A2- 2/5/6 mg RO7119929 Participants received RO7119929 QW with step-up dosing of 2/5/6 mg during Cycle 1.	Part A3-4 mg RO7119929 Participants received tocilizumab pre-treatment on Cycle 1 Day 1, approximately 2 hours prior to RO7119929 administration and 4 mg RO7119929 every week in 3-week cycles
Area Under the Curve (AUC) for RO7119929 Following Administration of RO7119929 Cycle 1, after 1st dose (Prodrug)	6.27 ng*hr/mL Geometric Coefficient of Variation 46.0	4.94 ng*hr/mL Geometric Coefficient of Variation 52.6	3.52 ng*hr/mL Geometric Coefficient of Variation 41.0	6.55 ng*hr/mL Geometric Coefficient of Variation 71.6	8.93 ng*hr/mL Geometric Coefficient of Variation 141	1.17 ng*hr/mL Geometric Coefficient of Variation 71.6	—	—	—
Area Under the Curve (AUC) for RO7119929 Following Administration of RO7119929 Cycle 1, after 1st dose (Active Drug)	31.4 ng*hr/mL Geometric Coefficient of Variation 50.7	123 ng*hr/mL Geometric Coefficient of Variation 41.6	164 ng*hr/mL Geometric Coefficient of Variation 4.51	251 ng*hr/mL Geometric Coefficient of Variation 69.9	314 ng*hr/mL Geometric Coefficient of Variation 28.3	265 ng*hr/mL Geometric Coefficient of Variation 48.9	—	—	—
Area Under the Curve (AUC) for RO7119929 Following Administration of RO7119929 Cycle 2, after 4th dose (Prodrug)	7.91 ng*hr/mL Geometric Coefficient of Variation 43.5	6.08 ng*hr/mL Geometric Coefficient of Variation 18.8	4.79 ng*hr/mL Geometric Coefficient of Variation 127	6.82 ng*hr/mL Geometric Coefficient of Variation 46.3	—	10.8 ng*hr/mL Geometric Coefficient of Variation 261	—	—	—
Area Under the Curve (AUC) for RO7119929 Following Administration of RO7119929 Cycle 2, after 4th dose (Active Drug)	39.9 ng*hr/mL Geometric Coefficient of Variation 57.4	130 ng*hr/mL Geometric Coefficient of Variation 42.9	155 ng*hr/mL Geometric Coefficient of Variation 6.28	202 ng*hr/mL Geometric Coefficient of Variation 56.0	—	242 ng*hr/mL Geometric Coefficient of Variation 32.8	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 15, Cycle 2 Day 1 (Cycle duration is 21 days)

Outcome measures

Outcome measures
Measure	Part A1-1 mg RO7119929 n=4 Participants Participants received 1mg RO7119929 every week in 3-week cycles.	Part A1-3 mg RO7119929 n=3 Participants Participants received 3 mg RO7119929 every week in 3-week cycles.	Part A1 -4 mg RO7119929 Participants received 4 mg RO7119929 every week in 3-week cycles	Part A1 - 6 mg RO7119929 Participants received 6 mg RO7119929 every week in 3-week cycles	Part A1 -9 mg RO7119929 Participants received 9 mg RO7119929 every week in 3-week cycles	Part B1-5 mg RO7119929 Participants with both available and evaluable tumor biopsy samples received 5 mg RO7119929 on Cycle 1 Day 1 to month 12	Part A2- 2/5/5 mg RO7119929 Participants received RO7119929 QW with step-up dosing of 2/5/5 mg during Cycle 1.	Part A2- 2/5/6 mg RO7119929 Participants received RO7119929 QW with step-up dosing of 2/5/6 mg during Cycle 1.	Part A3-4 mg RO7119929 Participants received tocilizumab pre-treatment on Cycle 1 Day 1, approximately 2 hours prior to RO7119929 administration and 4 mg RO7119929 every week in 3-week cycles
Area Under the Curve (AUC) for RO7119929 Following Administration of RO7119929, Oral Step-Up Dose Prodrug: Cycle 1 Day 15	5.38 ng*hr/mL Geometric Coefficient of Variation 89.6	4.79 ng*hr/mL Geometric Coefficient of Variation 134	—	—	—	—	—	—	—
Area Under the Curve (AUC) for RO7119929 Following Administration of RO7119929, Oral Step-Up Dose Prodrug: Cycle 2 Day 1	5.01 ng*hr/mL Geometric Coefficient of Variation 73.9	8.04 ng*hr/mL Geometric Coefficient of Variation 167	—	—	—	—	—	—	—
Area Under the Curve (AUC) for RO7119929 Following Administration of RO7119929, Oral Step-Up Dose Active Drug: Cycle 1 Day 15	213 ng*hr/mL Geometric Coefficient of Variation 31.1	170 ng*hr/mL Geometric Coefficient of Variation 23.5	—	—	—	—	—	—	—
Area Under the Curve (AUC) for RO7119929 Following Administration of RO7119929, Oral Step-Up Dose Active Drug: Cycle 2 Day 1	178 ng*hr/mL Geometric Coefficient of Variation 24.1	214 ng*hr/mL Geometric Coefficient of Variation 21.4	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1, after 1st dose, Cycle 2, after 4th dose (Each cycle is 21 days)

Population: Participants in 9 mg cohort were excluded from the Cycle 2 analysis (2 discontinued the study due to DLTs, the other 2 were re-dosed at 3 mg)

Outcome measures

Outcome measures
Measure	Part A1-1 mg RO7119929 n=4 Participants Participants received 1mg RO7119929 every week in 3-week cycles.	Part A1-3 mg RO7119929 n=6 Participants Participants received 3 mg RO7119929 every week in 3-week cycles.	Part A1 -4 mg RO7119929 n=3 Participants Participants received 4 mg RO7119929 every week in 3-week cycles	Part A1 - 6 mg RO7119929 n=10 Participants Participants received 6 mg RO7119929 every week in 3-week cycles	Part A1 -9 mg RO7119929 n=4 Participants Participants received 9 mg RO7119929 every week in 3-week cycles	Part B1-5 mg RO7119929 n=18 Participants Participants with both available and evaluable tumor biopsy samples received 5 mg RO7119929 on Cycle 1 Day 1 to month 12	Part A2- 2/5/5 mg RO7119929 Participants received RO7119929 QW with step-up dosing of 2/5/5 mg during Cycle 1.	Part A2- 2/5/6 mg RO7119929 Participants received RO7119929 QW with step-up dosing of 2/5/6 mg during Cycle 1.	Part A3-4 mg RO7119929 Participants received tocilizumab pre-treatment on Cycle 1 Day 1, approximately 2 hours prior to RO7119929 administration and 4 mg RO7119929 every week in 3-week cycles
Half-Life (T1/2) for RO7119929 Following Administration of RO7119929 Cycle 1, after 1st dose (Active Drug)	3.23 hours Geometric Coefficient of Variation 48.8	4.74 hours Geometric Coefficient of Variation 24.9	6.3 hours Geometric Coefficient of Variation 26.1	5.35 hours Geometric Coefficient of Variation 43.8	4.85 hours Geometric Coefficient of Variation 14.2	4.86 hours Geometric Coefficient of Variation 35.5	—	—	—
Half-Life (T1/2) for RO7119929 Following Administration of RO7119929 Cycle 2, after 4th dose (Prodrug)	1.45 hours Geometric Coefficient of Variation 30.3	1.33 hours Geometric Coefficient of Variation 37.7	1.38 hours Geometric Coefficient of Variation 75.0	1.55 hours Geometric Coefficient of Variation 55.5	—	1.45 hours Geometric Coefficient of Variation 61.8	—	—	—
Half-Life (T1/2) for RO7119929 Following Administration of RO7119929 Cycle 2, after 4th dose (Active Drug)	3.74 hours Geometric Coefficient of Variation 37.6	4.93 hours Geometric Coefficient of Variation 14.9	5.12 hours Geometric Coefficient of Variation 16.9	5.00 hours Geometric Coefficient of Variation 16.4	—	3.89 hours Geometric Coefficient of Variation 19.0	—	—	—
Half-Life (T1/2) for RO7119929 Following Administration of RO7119929 Cycle 1, after 1st dose (Prodrug)	0.896 hours Geometric Coefficient of Variation 3.77	1.54 hours Geometric Coefficient of Variation 31.1	1.02 hours Geometric Coefficient of Variation 22.7	1.84 hours Geometric Coefficient of Variation 58.3	2.46 hours Geometric Coefficient of Variation 65.0	1.70 hours Geometric Coefficient of Variation 35.3	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 15, Cycle 2 Day 1 (Cycle duration is 21 days)

Outcome measures

Outcome measures
Measure	Part A1-1 mg RO7119929 n=4 Participants Participants received 1mg RO7119929 every week in 3-week cycles.	Part A1-3 mg RO7119929 n=3 Participants Participants received 3 mg RO7119929 every week in 3-week cycles.	Part A1 -4 mg RO7119929 Participants received 4 mg RO7119929 every week in 3-week cycles	Part A1 - 6 mg RO7119929 Participants received 6 mg RO7119929 every week in 3-week cycles	Part A1 -9 mg RO7119929 Participants received 9 mg RO7119929 every week in 3-week cycles	Part B1-5 mg RO7119929 Participants with both available and evaluable tumor biopsy samples received 5 mg RO7119929 on Cycle 1 Day 1 to month 12	Part A2- 2/5/5 mg RO7119929 Participants received RO7119929 QW with step-up dosing of 2/5/5 mg during Cycle 1.	Part A2- 2/5/6 mg RO7119929 Participants received RO7119929 QW with step-up dosing of 2/5/6 mg during Cycle 1.	Part A3-4 mg RO7119929 Participants received tocilizumab pre-treatment on Cycle 1 Day 1, approximately 2 hours prior to RO7119929 administration and 4 mg RO7119929 every week in 3-week cycles
Half-Life (T1/2) for RO7119929 Following Administration of RO7119929, Oral Step-Up Dose Prodrug: Cycle 1 Day 15	1.49 hours Geometric Coefficient of Variation 42.4	1.56 hours Geometric Coefficient of Variation 57.4	—	—	—	—	—	—	—
Half-Life (T1/2) for RO7119929 Following Administration of RO7119929, Oral Step-Up Dose Prodrug: Cycle 2 Day 1	1.40 hours Geometric Coefficient of Variation 27.8	1.53 hours Geometric Coefficient of Variation 74.5	—	—	—	—	—	—	—
Half-Life (T1/2) for RO7119929 Following Administration of RO7119929, Oral Step-Up Dose Active Drug: Cycle 1 Day 15	5.11 hours Geometric Coefficient of Variation 24.6	5.84 hours Geometric Coefficient of Variation 14.5	—	—	—	—	—	—	—
Half-Life (T1/2) for RO7119929 Following Administration of RO7119929, Oral Step-Up Dose Active Drug: Cycle 2 Day 1	5.62 hours Geometric Coefficient of Variation 20.8	6.11 hours Geometric Coefficient of Variation 28.9	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline up to approximately 14 months

Progression-free survival (PFS) is defined as the time from randomization to disease progression or death from any cause.

Outcome measures

Outcome measures
Measure	Part A1-1 mg RO7119929 n=4 Participants Participants received 1mg RO7119929 every week in 3-week cycles.	Part A1-3 mg RO7119929 n=6 Participants Participants received 3 mg RO7119929 every week in 3-week cycles.	Part A1 -4 mg RO7119929 n=3 Participants Participants received 4 mg RO7119929 every week in 3-week cycles	Part A1 - 6 mg RO7119929 n=10 Participants Participants received 6 mg RO7119929 every week in 3-week cycles	Part A1 -9 mg RO7119929 n=4 Participants Participants received 9 mg RO7119929 every week in 3-week cycles	Part B1-5 mg RO7119929 n=18 Participants Participants with both available and evaluable tumor biopsy samples received 5 mg RO7119929 on Cycle 1 Day 1 to month 12	Part A2- 2/5/5 mg RO7119929 n=4 Participants Participants received RO7119929 QW with step-up dosing of 2/5/5 mg during Cycle 1.	Part A2- 2/5/6 mg RO7119929 n=5 Participants Participants received RO7119929 QW with step-up dosing of 2/5/6 mg during Cycle 1.	Part A3-4 mg RO7119929 n=1 Participants Participants received tocilizumab pre-treatment on Cycle 1 Day 1, approximately 2 hours prior to RO7119929 administration and 4 mg RO7119929 every week in 3-week cycles
Progression-Free Survival (PFS) According to RECIST v1.1	1.2 Months Interval 1.2 to In the chosen method to calculate the 95% confidence interval, the upper bound is not found	1.4 Months Interval 1.2 to 1.4	2.8 Months Interval 1.2 to In the chosen method to calculate the 95% confidence interval, the upper bound is not found	1.4 Months Interval 1.3 to 2.8	1.2 Months Interval 1.2 to In the chosen method to calculate the 95% confidence interval, the upper bound is not found	1.6 Months Interval 1.2 to 2.4	2.7 Months Interval 2.4 to In the chosen method to calculate the 95% confidence interval, the upper bound is not found	2.8 Months Interval 1.2 to In the chosen method to calculate the 95% confidence interval, the upper bound is not found	3.9 Months Interval 3.9 to 3.9

SECONDARY outcome

Timeframe: Baseline up to approximately 14 months

Population: Participants with missing tumor assessments and were not included in the efficacy analysis population for this outcome measure.

ORR is defined as the number of patients who achieve a response, which can either be complete response (complete disappearance of lesions) or partial response (reduction in the sum of maximal tumor diameters by at least 30% or more).

Outcome measures

Outcome measures
Measure	Part A1-1 mg RO7119929 n=4 Participants Participants received 1mg RO7119929 every week in 3-week cycles.	Part A1-3 mg RO7119929 n=6 Participants Participants received 3 mg RO7119929 every week in 3-week cycles.	Part A1 -4 mg RO7119929 n=3 Participants Participants received 4 mg RO7119929 every week in 3-week cycles	Part A1 - 6 mg RO7119929 n=9 Participants Participants received 6 mg RO7119929 every week in 3-week cycles	Part A1 -9 mg RO7119929 n=3 Participants Participants received 9 mg RO7119929 every week in 3-week cycles	Part B1-5 mg RO7119929 n=18 Participants Participants with both available and evaluable tumor biopsy samples received 5 mg RO7119929 on Cycle 1 Day 1 to month 12	Part A2- 2/5/5 mg RO7119929 n=4 Participants Participants received RO7119929 QW with step-up dosing of 2/5/5 mg during Cycle 1.	Part A2- 2/5/6 mg RO7119929 n=4 Participants Participants received RO7119929 QW with step-up dosing of 2/5/6 mg during Cycle 1.	Part A3-4 mg RO7119929 n=1 Participants Participants received tocilizumab pre-treatment on Cycle 1 Day 1, approximately 2 hours prior to RO7119929 administration and 4 mg RO7119929 every week in 3-week cycles
Objective Response Rate (ORR) According to RECIST v1.1 Partial Response	0 Participants Interval 0.0 to 62.24	0 Participants Interval 0.0 to 45.93	0 Participants Interval 0.0 to 70.76	0 Participants Interval 0.0 to 33.63	0 Participants Interval 0.0 to 70.76	0 Participants Interval 0.0 to 18.53	0 Participants Interval 0.0 to 60.24	0 Participants Interval 0.0 to 60.24	0 Participants Interval 0.0 to 97.5
Objective Response Rate (ORR) According to RECIST v1.1 Complete Response	0 Participants Interval 0.0 to 62.24	0 Participants Interval 0.0 to 45.93	0 Participants Interval 0.0 to 70.76	1 Participants Interval 0.28 to 48.25	0 Participants Interval 0.0 to 70.76	0 Participants Interval 0.0 to 18.53	0 Participants Interval 0.0 to 60.24	0 Participants Interval 0.0 to 60.24	0 Participants Interval 0.0 to 97.5

SECONDARY outcome

Timeframe: Baseline up to approximately 14 months

Overall survival (OS) is defined as the time from randomization to death

Outcome measures

Outcome measures
Measure	Part A1-1 mg RO7119929 n=4 Participants Participants received 1mg RO7119929 every week in 3-week cycles.	Part A1-3 mg RO7119929 n=6 Participants Participants received 3 mg RO7119929 every week in 3-week cycles.	Part A1 -4 mg RO7119929 n=3 Participants Participants received 4 mg RO7119929 every week in 3-week cycles	Part A1 - 6 mg RO7119929 n=10 Participants Participants received 6 mg RO7119929 every week in 3-week cycles	Part A1 -9 mg RO7119929 n=4 Participants Participants received 9 mg RO7119929 every week in 3-week cycles	Part B1-5 mg RO7119929 n=18 Participants Participants with both available and evaluable tumor biopsy samples received 5 mg RO7119929 on Cycle 1 Day 1 to month 12	Part A2- 2/5/5 mg RO7119929 n=4 Participants Participants received RO7119929 QW with step-up dosing of 2/5/5 mg during Cycle 1.	Part A2- 2/5/6 mg RO7119929 n=5 Participants Participants received RO7119929 QW with step-up dosing of 2/5/6 mg during Cycle 1.	Part A3-4 mg RO7119929 n=1 Participants Participants received tocilizumab pre-treatment on Cycle 1 Day 1, approximately 2 hours prior to RO7119929 administration and 4 mg RO7119929 every week in 3-week cycles
Overall Survival (OS)	3.2 Months Interval 1.6 to In the chosen method to calculate the 95% confidence interval, the upper bound is not found	5.1 Months Interval 2.9 to In the chosen method to calculate the 95% confidence interval, the upper bound is not found	7.9 Months Interval 5.5 to In the chosen method to calculate the 95% confidence interval, the upper bound is not found	NA Months Interval 5.5 to In the chosen method to calculate the 95% confidence interval, the upper bound is not found	2.9 Months Interval 2.9 to In the chosen method to calculate the 95% confidence interval, the upper bound is not found	8.0 Months Interval 3.9 to In the chosen method to calculate the 95% confidence interval, the upper bound is not found	NA Months Interval 3.4 to In the chosen method to calculate the 95% confidence interval, the upper bound is not found	NA Months In the chosen method to calculate the 95% confidence interval, the upper bound is not found	NA Months In the chosen method to calculate the 95% confidence interval, the upper bound is not found

Adverse Events

Part A1-1 mg RO7119929

Serious events: 1 serious events

Other events: 3 other events

Deaths: 3 deaths

Part A1-3 mg RO7119929

Serious events: 2 serious events

Other events: 6 other events

Deaths: 4 deaths

Part A1 -4 mg RO7119929

Serious events: 2 serious events

Other events: 3 other events

Deaths: 2 deaths

Part A1-6 mg RO7119929

Serious events: 4 serious events

Other events: 10 other events

Deaths: 4 deaths

Part A1-9 mg RO7119929

Serious events: 4 serious events

Other events: 3 other events

Deaths: 4 deaths

Part B1-5 mg RO7119929

Serious events: 11 serious events

Other events: 18 other events

Deaths: 8 deaths

Part A2- 2/5/5 mg RO7119929

Serious events: 1 serious events

Other events: 4 other events

Deaths: 1 deaths

Part A2- 2/5/6 mg RO7119929

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Part A3-4 mg RO7119929

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part A1-1 mg RO7119929 n=4 participants at risk Participants received 1mg RO7119929 every week in 3-week cycles.	Part A1-3 mg RO7119929 n=6 participants at risk Participants received 3 mg RO7119929 every week in 3-week cycles.	Part A1 -4 mg RO7119929 n=3 participants at risk Participants received 4 mg RO7119929 every week in 3-week cycles	Part A1-6 mg RO7119929 n=10 participants at risk Participants received 6 mg RO7119929 every week in 3-week cycles	Part A1-9 mg RO7119929 n=4 participants at risk Participants received 9 mg RO7119929 every week in 3-week cycles	Part B1-5 mg RO7119929 n=18 participants at risk Participants with both available and evaluable tumor biopsy samples received 5 mg RO7119929 on Cycle 1 Day 1 to month 12	Part A2- 2/5/5 mg RO7119929 n=4 participants at risk Participants received RO7119929 QW with step-up dosing of 2/5/5 mg during Cycle 1.	Part A2- 2/5/6 mg RO7119929 n=5 participants at risk Participants received RO7119929 QW with step-up dosing of 2/5/6 mg during Cycle 1.	Part A3-4 mg RO7119929 n=1 participants at risk Participants received tocilizumab pre-treatment on Cycle 1 Day 1, approximately 2 hours prior to RO7119929 administration and 4 mg RO7119929 every week in 3-week cycles
Blood and lymphatic system disorders Lymphopenia	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/18 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	20.0% 1/5 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Gastrointestinal disorders Small intestinal haemorrhage	25.0% 1/4 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/18 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
General disorders Gait disturbance	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/18 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	20.0% 1/5 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
General disorders Pyrexia	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	5.6% 1/18 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Hepatobiliary disorders Cholangitis	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	22.2% 4/18 • Number of events 6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Immune system disorders Cytokine release syndrome	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	33.3% 2/6 • Number of events 2 • Baseline up to 14 months Number of events includes all occurrences	66.7% 2/3 • Number of events 6 • Baseline up to 14 months Number of events includes all occurrences	40.0% 4/10 • Number of events 4 • Baseline up to 14 months Number of events includes all occurrences	100.0% 4/4 • Number of events 4 • Baseline up to 14 months Number of events includes all occurrences	50.0% 9/18 • Number of events 11 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	40.0% 2/5 • Number of events 3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Infections and infestations Bacteraemia	25.0% 1/4 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/18 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Infections and infestations Biliary tract infection	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	10.0% 1/10 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/18 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Infections and infestations Herpes simplex	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	25.0% 1/4 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/18 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Infections and infestations Pneumonia	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/18 • Baseline up to 14 months Number of events includes all occurrences	25.0% 1/4 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Infections and infestations Sepsis	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	5.6% 1/18 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Infections and infestations Septic shock	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/18 • Baseline up to 14 months Number of events includes all occurrences	25.0% 1/4 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Injury, poisoning and procedural complications Accidental overdose	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	25.0% 1/4 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/18 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Investigations Blood creatinine increased	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	5.6% 1/18 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	10.0% 1/10 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/18 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Nervous system disorders Spinal cord compression	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/18 • Baseline up to 14 months Number of events includes all occurrences	25.0% 1/4 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Surgical and medical procedures Spinal operation	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/18 • Baseline up to 14 months Number of events includes all occurrences	25.0% 1/4 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences

Other adverse events

Other adverse events
Measure	Part A1-1 mg RO7119929 n=4 participants at risk Participants received 1mg RO7119929 every week in 3-week cycles.	Part A1-3 mg RO7119929 n=6 participants at risk Participants received 3 mg RO7119929 every week in 3-week cycles.	Part A1 -4 mg RO7119929 n=3 participants at risk Participants received 4 mg RO7119929 every week in 3-week cycles	Part A1-6 mg RO7119929 n=10 participants at risk Participants received 6 mg RO7119929 every week in 3-week cycles	Part A1-9 mg RO7119929 n=4 participants at risk Participants received 9 mg RO7119929 every week in 3-week cycles	Part B1-5 mg RO7119929 n=18 participants at risk Participants with both available and evaluable tumor biopsy samples received 5 mg RO7119929 on Cycle 1 Day 1 to month 12	Part A2- 2/5/5 mg RO7119929 n=4 participants at risk Participants received RO7119929 QW with step-up dosing of 2/5/5 mg during Cycle 1.	Part A2- 2/5/6 mg RO7119929 n=5 participants at risk Participants received RO7119929 QW with step-up dosing of 2/5/6 mg during Cycle 1.	Part A3-4 mg RO7119929 n=1 participants at risk Participants received tocilizumab pre-treatment on Cycle 1 Day 1, approximately 2 hours prior to RO7119929 administration and 4 mg RO7119929 every week in 3-week cycles
Gastrointestinal disorders Oral pain	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	5.6% 1/18 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Gastrointestinal disorders Vomiting	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	33.3% 2/6 • Number of events 2 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	20.0% 2/10 • Number of events 2 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	5.6% 1/18 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	20.0% 1/5 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
General disorders Asthenia	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	30.0% 3/10 • Number of events 3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	16.7% 3/18 • Number of events 4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
General disorders Chest pain	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	5.6% 1/18 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
General disorders Chills	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	16.7% 1/6 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	10.0% 1/10 • Number of events 2 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	11.1% 2/18 • Number of events 4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	20.0% 1/5 • Number of events 2 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
General disorders Fatigue	25.0% 1/4 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	16.7% 1/6 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	66.7% 2/3 • Number of events 3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	25.0% 1/4 • Number of events 4 • Baseline up to 14 months Number of events includes all occurrences	11.1% 2/18 • Number of events 2 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	20.0% 1/5 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
General disorders General physical health deterioration	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/18 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	20.0% 1/5 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Blood and lymphatic system disorders Anaemia	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	10.0% 1/10 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	25.0% 1/4 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	11.1% 2/18 • Number of events 2 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Blood and lymphatic system disorders Leukocytosis	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	5.6% 1/18 • Number of events 2 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Blood and lymphatic system disorders Lymph node pain	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/18 • Baseline up to 14 months Number of events includes all occurrences	25.0% 1/4 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Blood and lymphatic system disorders Lymphocytosis	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	5.6% 1/18 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Blood and lymphatic system disorders Lymphopenia	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	30.0% 3/10 • Number of events 7 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	5.6% 1/18 • Number of events 2 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	20.0% 1/5 • Number of events 3 • Baseline up to 14 months Number of events includes all occurrences	100.0% 1/1 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences
Blood and lymphatic system disorders Neutropenia	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	16.7% 1/6 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/18 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Blood and lymphatic system disorders Neutrophilia	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	5.6% 1/18 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	10.0% 1/10 • Number of events 2 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	5.6% 1/18 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Blood and lymphatic system disorders Thrombocytosis	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	5.6% 1/18 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Cardiac disorders Atrioventricular block	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	25.0% 1/4 • Number of events 3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/18 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Cardiac disorders Supraventricular tachycardia	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	33.3% 1/3 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/18 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Gastrointestinal disorders Abdominal discomfort	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	25.0% 1/4 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/18 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Gastrointestinal disorders Abdominal distension	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	10.0% 1/10 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/18 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Gastrointestinal disorders Abdominal pain	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	10.0% 1/10 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	25.0% 1/4 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	16.7% 3/18 • Number of events 5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	20.0% 1/5 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Gastrointestinal disorders Abdominal pain upper	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	16.7% 1/6 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	11.1% 2/18 • Number of events 2 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Gastrointestinal disorders Ascites	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	25.0% 1/4 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/18 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Gastrointestinal disorders Constipation	25.0% 1/4 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	20.0% 2/10 • Number of events 2 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	11.1% 2/18 • Number of events 2 • Baseline up to 14 months Number of events includes all occurrences	25.0% 1/4 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	40.0% 2/5 • Number of events 2 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Gastrointestinal disorders Diarrhoea	25.0% 1/4 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	16.7% 1/6 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	10.0% 1/10 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	11.1% 2/18 • Number of events 3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	20.0% 1/5 • Number of events 3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Gastrointestinal disorders Dry mouth	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	25.0% 1/4 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/18 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	20.0% 1/5 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Gastrointestinal disorders Dyspepsia	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	10.0% 1/10 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/18 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Gastrointestinal disorders Haemorrhoids	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	5.6% 1/18 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Gastrointestinal disorders Nausea	25.0% 1/4 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	50.0% 3/6 • Number of events 5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	30.0% 3/10 • Number of events 8 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	5.6% 1/18 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	40.0% 2/5 • Number of events 3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
General disorders Influenza like illness	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	10.0% 1/10 • Number of events 19 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/18 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
General disorders Mucosal inflammation	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	16.7% 1/6 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/18 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
General disorders Oedema	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	5.6% 1/18 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
General disorders Oedema peripheral	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/18 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	20.0% 1/5 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
General disorders Pain	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	10.0% 1/10 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	5.6% 1/18 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	25.0% 1/4 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
General disorders Pyrexia	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	16.7% 1/6 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	10.0% 1/10 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	27.8% 5/18 • Number of events 8 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	20.0% 1/5 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Hepatobiliary disorders Hepatic pain	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	25.0% 1/4 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/18 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Hepatobiliary disorders Portal vein thrombosis	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	5.6% 1/18 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Immune system disorders Cytokine release syndrome	25.0% 1/4 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	100.0% 6/6 • Number of events 17 • Baseline up to 14 months Number of events includes all occurrences	100.0% 3/3 • Number of events 5 • Baseline up to 14 months Number of events includes all occurrences	70.0% 7/10 • Number of events 80 • Baseline up to 14 months Number of events includes all occurrences	25.0% 1/4 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	77.8% 14/18 • Number of events 43 • Baseline up to 14 months Number of events includes all occurrences	75.0% 3/4 • Number of events 10 • Baseline up to 14 months Number of events includes all occurrences	60.0% 3/5 • Number of events 12 • Baseline up to 14 months Number of events includes all occurrences	100.0% 1/1 • Number of events 2 • Baseline up to 14 months Number of events includes all occurrences
Infections and infestations COVID-19	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	5.6% 1/18 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Infections and infestations Cellulitis	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	5.6% 1/18 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Infections and infestations Herpes virus infection	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/18 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	20.0% 1/5 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Infections and infestations Infection	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	5.6% 1/18 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Infections and infestations Oral herpes	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/18 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	20.0% 1/5 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Infections and infestations Pneumonia	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/18 • Baseline up to 14 months Number of events includes all occurrences	25.0% 1/4 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Infections and infestations Subcutaneous abscess	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/18 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	20.0% 1/5 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	5.6% 1/18 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Injury, poisoning and procedural complications Nasal injury	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	5.6% 1/18 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Investigations Alanine aminotransferase increased	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	30.0% 3/10 • Number of events 4 • Baseline up to 14 months Number of events includes all occurrences	25.0% 1/4 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	22.2% 4/18 • Number of events 4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	40.0% 2/5 • Number of events 2 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Investigations Aspartate aminotransferase increased	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	16.7% 1/6 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	30.0% 3/10 • Number of events 6 • Baseline up to 14 months Number of events includes all occurrences	25.0% 1/4 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	27.8% 5/18 • Number of events 6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	40.0% 2/5 • Number of events 2 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Investigations Blood bilirubin increased	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	10.0% 1/10 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	25.0% 1/4 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	22.2% 4/18 • Number of events 5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Investigations Blood calcium increased	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	10.0% 1/10 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/18 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Investigations Blood lactate dehydrogenase increased	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	25.0% 1/4 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	5.6% 1/18 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Investigations Electrocardiogram QT prolonged	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	33.3% 1/3 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/18 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Investigations Lipase increased	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/18 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	20.0% 1/5 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Investigations Liver function test abnormal	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	10.0% 1/10 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/18 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Investigations Lymphocyte count decreased	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	16.7% 1/6 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	11.1% 2/18 • Number of events 2 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Investigations N-terminal prohormone brain natriuretic peptide increased	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	10.0% 1/10 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/18 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Investigations Neutrophil count decreased	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	5.6% 1/18 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	100.0% 1/1 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences
Investigations Platelet count decreased	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	25.0% 1/4 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	11.1% 2/18 • Number of events 2 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Investigations Procalcitonin increased	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	5.6% 1/18 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Investigations Transaminases increased	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	5.6% 1/18 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Investigations Weight decreased	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	16.7% 1/6 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/18 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	20.0% 1/5 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Metabolism and nutrition disorders Cachexia	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	16.7% 1/6 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/18 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Metabolism and nutrition disorders Decreased appetite	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	16.7% 1/6 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	33.3% 1/3 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	10.0% 1/10 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	25.0% 1/4 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	5.6% 1/18 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	60.0% 3/5 • Number of events 3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	5.6% 1/18 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	30.0% 3/10 • Number of events 3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/18 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	25.0% 1/4 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/18 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/18 • Baseline up to 14 months Number of events includes all occurrences	25.0% 1/4 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/18 • Baseline up to 14 months Number of events includes all occurrences	25.0% 1/4 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	33.3% 1/3 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/18 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	20.0% 1/5 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	10.0% 1/10 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	5.6% 1/18 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	33.3% 1/3 • Number of events 2 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	25.0% 1/4 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/18 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	20.0% 2/10 • Number of events 5 • Baseline up to 14 months Number of events includes all occurrences	25.0% 1/4 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/18 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	20.0% 1/5 • Number of events 2 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	10.0% 1/10 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	5.6% 1/18 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/18 • Baseline up to 14 months Number of events includes all occurrences	25.0% 1/4 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	100.0% 1/1 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences
Musculoskeletal and connective tissue disorders Flank pain	25.0% 1/4 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/18 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/18 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	20.0% 1/5 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	10.0% 1/10 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/18 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/18 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	20.0% 1/5 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	5.6% 1/18 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	25.0% 1/4 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	5.6% 1/18 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	16.7% 1/6 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/18 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Nervous system disorders Headache	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	16.7% 1/6 • Number of events 2 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	16.7% 3/18 • Number of events 4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Nervous system disorders Hypoaesthesia	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/18 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	20.0% 1/5 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Nervous system disorders Neurotoxicity	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	10.0% 1/10 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/18 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Psychiatric disorders Insomnia	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/18 • Baseline up to 14 months Number of events includes all occurrences	25.0% 1/4 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Renal and urinary disorders Renal impairment	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	11.1% 2/18 • Number of events 2 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Reproductive system and breast disorders Pelvic pain	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	10.0% 1/10 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/18 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	11.1% 2/18 • Number of events 2 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	25.0% 1/4 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/18 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	5.6% 1/18 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/18 • Baseline up to 14 months Number of events includes all occurrences	25.0% 1/4 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	16.7% 1/6 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/18 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Skin and subcutaneous tissue disorders Macule	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	16.7% 1/6 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/18 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Skin and subcutaneous tissue disorders Pruritus	25.0% 1/4 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	5.6% 1/18 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Skin and subcutaneous tissue disorders Rash	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	16.7% 1/6 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/18 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	100.0% 1/1 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences
Skin and subcutaneous tissue disorders Skin reaction	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/18 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	20.0% 1/5 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/18 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	100.0% 1/1 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences
Vascular disorders Flushing	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	5.6% 1/18 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Vascular disorders Hypotension	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	33.3% 1/3 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/18 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences
Vascular disorders Phlebitis	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/6 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/3 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/10 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	5.6% 1/18 • Number of events 1 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/4 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/5 • Baseline up to 14 months Number of events includes all occurrences	0.00% 0/1 • Baseline up to 14 months Number of events includes all occurrences

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800-821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER