Trial Outcomes & Findings for Phase Ib Study to Assess Safety and Preliminary Efficacy of Tafasitamab or Tafasitamab Plus Lenalidomide in Addition to R-CHOP in Patients With Newly Diagnosed DLBCL (NCT NCT04134936)

NCT ID: NCT04134936

Last Updated: 2024-10-16

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 66 participants
• Primary outcome timeframe: 6 months approximately
• Results posted on: 2024-10-16

Participant Flow

Participant milestones

Measure	Arm A Tafasitamab in addition to R-CHOP Tafasitamab: Six 21-day cycles of tafasitamab (12 mg/kg intravenously, on Day 1, 8 and 15) in addition to R-CHOP	Arm B Tafasitamab plus lenalidomide in addition to R-CHOP Tafasitamab plus lenalidomide: Six 21-day cycles of tafasitamab (12 mg/kg intravenously, on Day 1, 8 and 15) plus lenalidomide (starting dose 25 mg orally, on Day 1-10) in addition to R-CHOP
Overall Study STARTED	33	33
Overall Study COMPLETED	26	27
Overall Study NOT COMPLETED	7	6

Reasons for withdrawal

Measure	Arm A Tafasitamab in addition to R-CHOP Tafasitamab: Six 21-day cycles of tafasitamab (12 mg/kg intravenously, on Day 1, 8 and 15) in addition to R-CHOP	Arm B Tafasitamab plus lenalidomide in addition to R-CHOP Tafasitamab plus lenalidomide: Six 21-day cycles of tafasitamab (12 mg/kg intravenously, on Day 1, 8 and 15) plus lenalidomide (starting dose 25 mg orally, on Day 1-10) in addition to R-CHOP
Overall Study Adverse Event	3	2
Overall Study Withdrawal by Subject	2	3
Overall Study Physician Decision	0	1
Overall Study Progressive disease, joined another trial	1	0
Overall Study Progressive disease	1	0

Baseline Characteristics

Phase Ib Study to Assess Safety and Preliminary Efficacy of Tafasitamab or Tafasitamab Plus Lenalidomide in Addition to R-CHOP in Patients With Newly Diagnosed DLBCL

Baseline characteristics by cohort

Measure	Arm A n=33 Participants Tafasitamab in addition to R-CHOP Tafasitamab: Six 21-day cycles of tafasitamab (12 mg/kg intravenously, on Day 1, 8 and 15) in addition to R-CHOP	Arm B n=33 Participants Tafasitamab plus lenalidomide in addition to R-CHOP Tafasitamab plus lenalidomide: Six 21-day cycles of tafasitamab (12 mg/kg intravenously, on Day 1, 8 and 15) plus lenalidomide (starting dose 25 mg orally, on Day 1-10) in addition to R-CHOP	Total n=66 Participants Total of all reporting groups
Age, Continuous	63.8 years STANDARD_DEVIATION 11.64 • n=5 Participants	61.4 years STANDARD_DEVIATION 12.34 • n=7 Participants	62.6 years STANDARD_DEVIATION 11.96 • n=5 Participants
Age, Customized 18-64 years	16 Participants n=5 Participants	17 Participants n=7 Participants	33 Participants n=5 Participants
Age, Customized 65-84 years	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants
Age, Customized Greater than or equal to 85 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	20 Participants n=7 Participants	38 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	13 Participants n=7 Participants	28 Participants n=5 Participants
Race/Ethnicity, Customized White	31 Participants n=5 Participants	33 Participants n=7 Participants	64 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Weight at Baseline (kg)	73.03 kg STANDARD_DEVIATION 16.375 • n=5 Participants	77.27 kg STANDARD_DEVIATION 16.016 • n=7 Participants	75.15 kg STANDARD_DEVIATION 16.213 • n=5 Participants

PRIMARY outcome

Timeframe: 6 months approximately

Population: No participants in the "Arm A" Group were assessed for the "Patients with TEAE related to Lenalidomide only" row, since they did not receive Lenalidomide.

Outcome measures

Measure	Arm A n=33 Participants Tafasitamab in addition to R-CHOP Tafasitamab: Six 21-day cycles of tafasitamab (12 mg/kg intravenously, on Day 1, 8 and 15) in addition to R-CHOP	Arm B n=33 Participants Tafasitamab plus lenalidomide in addition to R-CHOP Tafasitamab plus lenalidomide: Six 21-day cycles of tafasitamab (12 mg/kg intravenously, on Day 1, 8 and 15) plus lenalidomide (starting dose 25 mg orally, on Day 1-10) in addition to R-CHOP
Incidence and Severity of Treatment-emergent Adverse Events (TEAEs) Patients with any TEAE	33 Participants	33 Participants
Incidence and Severity of Treatment-emergent Adverse Events (TEAEs) Patients with any study treatment-related TEAE	31 Participants	32 Participants
Incidence and Severity of Treatment-emergent Adverse Events (TEAEs) Patients with TEAE related to Tafasitamab only	9 Participants	5 Participants
Incidence and Severity of Treatment-emergent Adverse Events (TEAEs) Patients with TEAE related to Lenalidomide only	—	16 Participants
Incidence and Severity of Treatment-emergent Adverse Events (TEAEs) Patients with TEAE related to R-CHOP only	29 Participants	23 Participants
Incidence and Severity of Treatment-emergent Adverse Events (TEAEs) Patients with any grade ≥3 TEAE	27 Participants	30 Participants
Incidence and Severity of Treatment-emergent Adverse Events (TEAEs) Patients with any serious TEAE	14 Participants	17 Participants

SECONDARY outcome

Timeframe: 6 months approximately

The ORR at EOT was defined as the proportion of patients with Complete Response (CR) or Partial response (PR) based on the response achieved at the EOT Visit/early treatment discontinuation visit.

Outcome measures

Measure	Arm A n=33 Participants Tafasitamab in addition to R-CHOP Tafasitamab: Six 21-day cycles of tafasitamab (12 mg/kg intravenously, on Day 1, 8 and 15) in addition to R-CHOP	Arm B n=33 Participants Tafasitamab plus lenalidomide in addition to R-CHOP Tafasitamab plus lenalidomide: Six 21-day cycles of tafasitamab (12 mg/kg intravenously, on Day 1, 8 and 15) plus lenalidomide (starting dose 25 mg orally, on Day 1-10) in addition to R-CHOP
Objective Response Rate (ORR) at the End of Treatment (EOT)	25 Participants	27 Participants

SECONDARY outcome

Timeframe: 6 months approximately

Outcome measures

Measure	Arm A n=33 Participants Tafasitamab in addition to R-CHOP Tafasitamab: Six 21-day cycles of tafasitamab (12 mg/kg intravenously, on Day 1, 8 and 15) in addition to R-CHOP	Arm B n=33 Participants Tafasitamab plus lenalidomide in addition to R-CHOP Tafasitamab plus lenalidomide: Six 21-day cycles of tafasitamab (12 mg/kg intravenously, on Day 1, 8 and 15) plus lenalidomide (starting dose 25 mg orally, on Day 1-10) in addition to R-CHOP
Metabolic, PET-negative Complete Response (CR) Rate at the End of Treatment	24 Participants	22 Participants

SECONDARY outcome

Timeframe: 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events

Outcome measures

Measure	Arm A n=33 Participants Tafasitamab in addition to R-CHOP Tafasitamab: Six 21-day cycles of tafasitamab (12 mg/kg intravenously, on Day 1, 8 and 15) in addition to R-CHOP	Arm B n=33 Participants Tafasitamab plus lenalidomide in addition to R-CHOP Tafasitamab plus lenalidomide: Six 21-day cycles of tafasitamab (12 mg/kg intravenously, on Day 1, 8 and 15) plus lenalidomide (starting dose 25 mg orally, on Day 1-10) in addition to R-CHOP
Incidence and Severity of Adverse Events (AEs) in the Follow-up (FU) Period Patients with at least 1 AE in the FU period	26 Participants	26 Participants
Incidence and Severity of Adverse Events (AEs) in the Follow-up (FU) Period Patients with a Grade ≥3 TEAE in the FU period	9 Participants	13 Participants
Incidence and Severity of Adverse Events (AEs) in the Follow-up (FU) Period Patients with at least 1 treatment related AE in the FU period	9 Participants	7 Participants

SECONDARY outcome

Timeframe: 24 months approximately

The best ORR was defined as the proportion of patients with Complete Response (CR) or Partial Response (PR) as the best response until the EOS.

Outcome measures

Measure	Arm A n=33 Participants Tafasitamab in addition to R-CHOP Tafasitamab: Six 21-day cycles of tafasitamab (12 mg/kg intravenously, on Day 1, 8 and 15) in addition to R-CHOP	Arm B n=33 Participants Tafasitamab plus lenalidomide in addition to R-CHOP Tafasitamab plus lenalidomide: Six 21-day cycles of tafasitamab (12 mg/kg intravenously, on Day 1, 8 and 15) plus lenalidomide (starting dose 25 mg orally, on Day 1-10) in addition to R-CHOP
Best Objective Response Rate (ORR) Until the End of Study (EOS)	30 Participants	31 Participants

SECONDARY outcome

Timeframe: 24 months approximately

Outcome measures

Measure	Arm A n=33 Participants Tafasitamab in addition to R-CHOP Tafasitamab: Six 21-day cycles of tafasitamab (12 mg/kg intravenously, on Day 1, 8 and 15) in addition to R-CHOP	Arm B n=33 Participants Tafasitamab plus lenalidomide in addition to R-CHOP Tafasitamab plus lenalidomide: Six 21-day cycles of tafasitamab (12 mg/kg intravenously, on Day 1, 8 and 15) plus lenalidomide (starting dose 25 mg orally, on Day 1-10) in addition to R-CHOP
Metabolic, PET-negative Complete Response (CR) Rate Until the End of Study	28 Participants	23 Participants

SECONDARY outcome

Timeframe: 24 months approximately

As many patients had their data censored, due to completing the study without disease progression or death due to any cause, the probability of PFS (%) was used.

Outcome measures

Measure	Arm A n=33 Participants Tafasitamab in addition to R-CHOP Tafasitamab: Six 21-day cycles of tafasitamab (12 mg/kg intravenously, on Day 1, 8 and 15) in addition to R-CHOP	Arm B n=33 Participants Tafasitamab plus lenalidomide in addition to R-CHOP Tafasitamab plus lenalidomide: Six 21-day cycles of tafasitamab (12 mg/kg intravenously, on Day 1, 8 and 15) plus lenalidomide (starting dose 25 mg orally, on Day 1-10) in addition to R-CHOP
Progression-free Survival (PFS) at 12 and 24 Months Probability of PFS (%) at 12 months	83.1 percent Interval 64.0 to 92.6	76.8 percent Interval 57.1 to 88.3
Progression-free Survival (PFS) at 12 and 24 Months Probability of PFS (%) at 24 months	72.7 percent Interval 52.7 to 85.3	76.8 percent Interval 57.1 to 88.3

SECONDARY outcome

Timeframe: 24 months approximately

As many patients had their data censored, due to completing the study without disease progression, death due to any cause, or the start of a new anti-lymphoma treatment, the probability of EFS (%) was used.

Outcome measures

Measure	Arm A n=33 Participants Tafasitamab in addition to R-CHOP Tafasitamab: Six 21-day cycles of tafasitamab (12 mg/kg intravenously, on Day 1, 8 and 15) in addition to R-CHOP	Arm B n=33 Participants Tafasitamab plus lenalidomide in addition to R-CHOP Tafasitamab plus lenalidomide: Six 21-day cycles of tafasitamab (12 mg/kg intravenously, on Day 1, 8 and 15) plus lenalidomide (starting dose 25 mg orally, on Day 1-10) in addition to R-CHOP
Event-free Survival (EFS) at 12 and 24 Months Probability of EFS (%) at 12 months	77.4 percent Interval 58.4 to 88.5	68.0 percent Interval 48.6 to 81.4
Event-free Survival (EFS) at 12 and 24 Months Probability of EFS (%) at 24 months	67.7 percent Interval 48.4 to 81.2	68.0 percent Interval 48.6 to 81.4

SECONDARY outcome

Timeframe: 24 months approximately

As many patients had their data censored, due to completing the study without needing to receive another anti-lymphoma treatment, the Probability of TTNT (%) was used. Time to next anti-lymphoma treatment survival % estimate was the estimated probability that a patient remained TTNT-free up to the specified point in time.

Outcome measures

Measure	Arm A n=33 Participants Tafasitamab in addition to R-CHOP Tafasitamab: Six 21-day cycles of tafasitamab (12 mg/kg intravenously, on Day 1, 8 and 15) in addition to R-CHOP	Arm B n=33 Participants Tafasitamab plus lenalidomide in addition to R-CHOP Tafasitamab plus lenalidomide: Six 21-day cycles of tafasitamab (12 mg/kg intravenously, on Day 1, 8 and 15) plus lenalidomide (starting dose 25 mg orally, on Day 1-10) in addition to R-CHOP
Time to Next Anti-lymphoma Treatment (TTNT) Probability of TTNT (%) at 12 months	77.4 percent Interval 58.4 to 88.5	71.9 percent Interval 52.9 to 84.3
Time to Next Anti-lymphoma Treatment (TTNT) Probability of TTNT (%) at 24 months	71.0 percent Interval 51.6 to 83.7	68.8 percent Interval 49.7 to 81.8

SECONDARY outcome

Timeframe: 24 months approximately

As many patients had their data censored, due to completing the study without death from any cause, the probability of OS (%) was used.

Outcome measures

Measure	Arm A n=33 Participants Tafasitamab in addition to R-CHOP Tafasitamab: Six 21-day cycles of tafasitamab (12 mg/kg intravenously, on Day 1, 8 and 15) in addition to R-CHOP	Arm B n=33 Participants Tafasitamab plus lenalidomide in addition to R-CHOP Tafasitamab plus lenalidomide: Six 21-day cycles of tafasitamab (12 mg/kg intravenously, on Day 1, 8 and 15) plus lenalidomide (starting dose 25 mg orally, on Day 1-10) in addition to R-CHOP
Overall Survival at 12 and 24 Months Probability of OS (%) at 12 months	90.3 percent Interval 72.9 to 96.8	93.8 percent Interval 77.3 to 98.4
Overall Survival at 12 and 24 Months Probability of OS (%) at 24 months	90.3 percent Interval 72.9 to 96.8	93.8 percent Interval 77.3 to 98.4

SECONDARY outcome

Timeframe: 12 months approximately

Population: One patient in the Tafasitamab in addition to R-CHOP arm (Arm A) was missing a baseline sample and therefore could not be included in this analysis. In addition, no post-baseline evaluation was available for one patient in Arm A and one patient in Arm B hence the number of analyzed participants differs from overall.

Outcome measures

Measure	Arm A n=32 Participants Tafasitamab in addition to R-CHOP Tafasitamab: Six 21-day cycles of tafasitamab (12 mg/kg intravenously, on Day 1, 8 and 15) in addition to R-CHOP	Arm B n=33 Participants Tafasitamab plus lenalidomide in addition to R-CHOP Tafasitamab plus lenalidomide: Six 21-day cycles of tafasitamab (12 mg/kg intravenously, on Day 1, 8 and 15) plus lenalidomide (starting dose 25 mg orally, on Day 1-10) in addition to R-CHOP
Anti-tafasitamab Antibodies Formation Patients with pre-existing anti-tafasitamab antibodies	1 Participants	0 Participants
Anti-tafasitamab Antibodies Formation Patients without anti-tafasitamab antibodies after start of treatment	30 Participants	32 Participants
Anti-tafasitamab Antibodies Formation Patients with anti-tafasitamab antibodies after the start of treatment	1 Participants	0 Participants
Anti-tafasitamab Antibodies Formation Patients with treatment-induced anti-tafasitamab antibodies	0 Participants	0 Participants
Anti-tafasitamab Antibodies Formation Patients with treatment-boosted anti-tafasitamab antibodies	0 Participants	0 Participants

Adverse Events

Arm A

Serious events: 14 serious events

Other events: 31 other events

Deaths: 4 deaths

Arm B

Serious events: 17 serious events

Other events: 32 other events

Deaths: 2 deaths

Serious adverse events

Measure	Arm A n=33 participants at risk Tafasitamab in addition to R-CHOP Tafasitamab: Six 21-day cycles of tafasitamab (12 mg/kg intravenously, on Day 1, 8 and 15) in addition to R-CHOP	Arm B n=33 participants at risk Tafasitamab plus lenalidomide in addition to R-CHOP Tafasitamab plus lenalidomide: Six 21-day cycles of tafasitamab (12 mg/kg intravenously, on Day 1, 8 and 15) plus lenalidomide (starting dose 25 mg orally, on Day 1-10) in addition to R-CHOP
Blood and lymphatic system disorders Neutropenia	6.1% 2/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	6.1% 2/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Blood and lymphatic system disorders Anaemia	3.0% 1/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	0.00% 0/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Blood and lymphatic system disorders Thrombocytopenia	3.0% 1/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	0.00% 0/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Blood and lymphatic system disorders Febrile neutropenia	15.2% 5/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	15.2% 5/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Gastrointestinal disorders Abdominal pain	0.00% 0/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	3.0% 1/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	3.0% 1/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Nervous system disorders Syncope	0.00% 0/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	6.1% 2/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Nervous system disorders Generalized tonic-clonic seizure	0.00% 0/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	3.0% 1/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
General disorders Asthenia	3.0% 1/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	0.00% 0/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
General disorders Pyrexia	3.0% 1/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	6.1% 2/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
General disorders Device-related thrombosis	0.00% 0/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	3.0% 1/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Infections and infestations Urinary tract infection	3.0% 1/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	3.0% 1/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Infections and infestations Infection	3.0% 1/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	0.00% 0/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Infections and infestations Pneumocystis jirovecii pneumonia	0.00% 0/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	3.0% 1/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Infections and infestations Sepsis	3.0% 1/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	0.00% 0/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Infections and infestations Bronchitis	0.00% 0/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	3.0% 1/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Infections and infestations COVID-19 pneumonia	0.00% 0/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	3.0% 1/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Infections and infestations Campylobacter gastroenteritis	0.00% 0/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	3.0% 1/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Infections and infestations Cytomegalovirus infection	0.00% 0/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	3.0% 1/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Infections and infestations Enterocolitis infectious	3.0% 1/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	0.00% 0/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Infections and infestations Escherichia sepsis	3.0% 1/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	0.00% 0/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Infections and infestations Paraspinal abscess	3.0% 1/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	0.00% 0/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Infections and infestations Retroperitoneal abscess	0.00% 0/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	3.0% 1/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Infections and infestations Salmonellosis	0.00% 0/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	3.0% 1/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Infections and infestations Urosepsis	3.0% 1/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	0.00% 0/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	3.0% 1/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Metabolism and nutrition disorders Tumour lysis syndrome	3.0% 1/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	0.00% 0/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	6.1% 2/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	0.00% 0/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Injury, poisoning and procedural complications Infusion-related reaction	3.0% 1/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	0.00% 0/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Injury, poisoning and procedural complications Post lumbar puncture syndrome	3.0% 1/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	0.00% 0/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Psychiatric disorders Depression suicidal	3.0% 1/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	0.00% 0/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Vascular disorders Hypotension	0.00% 0/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	6.1% 2/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Vascular disorders Deep vein thrombosis	0.00% 0/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	3.0% 1/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Investigations Electrocardiogram QT prolonged	0.00% 0/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	3.0% 1/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Cardiac disorders Atrial fibrillation	3.0% 1/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	0.00% 0/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Cardiac disorders Acute coronary syndrome	3.0% 1/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	0.00% 0/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Cardiac disorders Cardiac failure	3.0% 1/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	0.00% 0/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Cardiac disorders Cardiac failure acute	3.0% 1/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	0.00% 0/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Cardiac disorders Myocarditis	3.0% 1/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	0.00% 0/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign lung neoplasm	3.0% 1/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	0.00% 0/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Paraneoplastic syndrome	3.0% 1/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	0.00% 0/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	3.0% 1/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	0.00% 0/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Renal and urinary disorders Acute kidney injury	3.0% 1/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	0.00% 0/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Immune system disorders Anaphylactic reaction	0.00% 0/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	3.0% 1/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Endocrine disorders Inappropriate antidiuretic hormone secretion	3.0% 1/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	0.00% 0/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.

Other adverse events

Measure	Arm A n=33 participants at risk Tafasitamab in addition to R-CHOP Tafasitamab: Six 21-day cycles of tafasitamab (12 mg/kg intravenously, on Day 1, 8 and 15) in addition to R-CHOP	Arm B n=33 participants at risk Tafasitamab plus lenalidomide in addition to R-CHOP Tafasitamab plus lenalidomide: Six 21-day cycles of tafasitamab (12 mg/kg intravenously, on Day 1, 8 and 15) plus lenalidomide (starting dose 25 mg orally, on Day 1-10) in addition to R-CHOP
Blood and lymphatic system disorders Neutropenia	54.5% 18/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	78.8% 26/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Blood and lymphatic system disorders Anaemia	48.5% 16/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	60.6% 20/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Blood and lymphatic system disorders Thrombocytopenia	18.2% 6/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	42.4% 14/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Blood and lymphatic system disorders Leukopenia	30.3% 10/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	27.3% 9/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Blood and lymphatic system disorders Lymphopenia	12.1% 4/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	24.2% 8/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Gastrointestinal disorders Stomatitis	18.2% 6/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	21.2% 7/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Gastrointestinal disorders Diarrhoea	30.3% 10/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	33.3% 11/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Gastrointestinal disorders Nausea	30.3% 10/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	27.3% 9/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Gastrointestinal disorders Constipation	30.3% 10/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	24.2% 8/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Gastrointestinal disorders Vomiting	30.3% 10/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	15.2% 5/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Gastrointestinal disorders Abdominal pain	15.2% 5/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	12.1% 4/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Gastrointestinal disorders Dyspepsia	9.1% 3/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	0.00% 0/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Nervous system disorders Neuropathy peripheral	27.3% 9/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	30.3% 10/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Nervous system disorders Dysgeusia	12.1% 4/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	12.1% 4/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Nervous system disorders Peripheral sensory neuropathy	15.2% 5/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	6.1% 2/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Nervous system disorders Paraesthesia	3.0% 1/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	6.1% 2/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Nervous system disorders Aphasia	6.1% 2/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	0.00% 0/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
General disorders Asthenia	18.2% 6/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	24.2% 8/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
General disorders Fatigue	33.3% 11/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	15.2% 5/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
General disorders Oedema peripheral	6.1% 2/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	12.1% 4/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Infections and infestations Oral candidiasis	6.1% 2/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	6.1% 2/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Infections and infestations Oral herpes	3.0% 1/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	6.1% 2/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Injury, poisoning and procedural complications Infusion-related reaction	21.2% 7/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	21.2% 7/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Metabolism and nutrition disorders Hypokalaemia	21.2% 7/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	27.3% 9/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	9.1% 3/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Metabolism and nutrition disorders Dehydration	9.1% 3/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	9.1% 3/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Metabolism and nutrition disorders Hyperphosphataemia	6.1% 2/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	9.1% 3/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	9.1% 3/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Cardiac disorders Sinus tachycardia	6.1% 2/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	0.00% 0/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Investigations Weight decreased	15.2% 5/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	0.00% 0/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Investigations C-reactive protein increased	6.1% 2/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	6.1% 2/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Musculoskeletal and connective tissue disorders Muscle spasms	3.0% 1/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	15.2% 5/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Ear and labyrinth disorders Vertigo	6.1% 2/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	6.1% 2/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Psychiatric disorders Insomnia	27.3% 9/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	18.2% 6/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Vascular disorders Hypotension	15.2% 5/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	15.2% 5/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Gastrointestinal disorders Haemorrhoids	6.1% 2/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	9.1% 3/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Gastrointestinal disorders Abdominal pain lower	3.0% 1/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	9.1% 3/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Gastrointestinal disorders Abdominal distension	6.1% 2/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	0.00% 0/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	6.1% 2/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Nervous system disorders Headache	9.1% 3/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	12.1% 4/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Nervous system disorders Dizziness	6.1% 2/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	9.1% 3/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Nervous system disorders Syncope	6.1% 2/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	0.00% 0/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
General disorders Malaise	0.00% 0/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	9.1% 3/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
General disorders Pyrexia	15.2% 5/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	6.1% 2/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Infections and infestations Infection	6.1% 2/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	0.00% 0/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Infections and infestations Pneumonia	3.0% 1/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	6.1% 2/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Infections and infestations Conjunctivitis	6.1% 2/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	0.00% 0/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Musculoskeletal and connective tissue disorders Back pain	12.1% 4/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	12.1% 4/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Musculoskeletal and connective tissue disorders Pain in extremity	6.1% 2/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	15.2% 5/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Musculoskeletal and connective tissue disorders Bone pain	6.1% 2/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	9.1% 3/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Musculoskeletal and connective tissue disorders Myalgia	12.1% 4/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	3.0% 1/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Musculoskeletal and connective tissue disorders Arthralgia	12.1% 4/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	0.00% 0/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Metabolism and nutrition disorders Hypomagnesaemia	3.0% 1/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	12.1% 4/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Metabolism and nutrition disorders Hypocalcaemia	3.0% 1/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	9.1% 3/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Metabolism and nutrition disorders Hypophosphataemia	3.0% 1/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	9.1% 3/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Metabolism and nutrition disorders Hyponatraemia	6.1% 2/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	3.0% 1/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Metabolism and nutrition disorders Folate deficiency	6.1% 2/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	0.00% 0/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Respiratory, thoracic and mediastinal disorders Dyspnoea	12.1% 4/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	6.1% 2/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	3.0% 1/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	15.2% 5/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Respiratory, thoracic and mediastinal disorders Cough	6.1% 2/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	9.1% 3/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Respiratory, thoracic and mediastinal disorders Dysphonia	6.1% 2/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	0.00% 0/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Respiratory, thoracic and mediastinal disorders Hiccups	6.1% 2/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	0.00% 0/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Psychiatric disorders Anxiety	0.00% 0/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	9.1% 3/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Skin and subcutaneous tissue disorders Alopecia	18.2% 6/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	12.1% 4/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Skin and subcutaneous tissue disorders Rash	3.0% 1/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	12.1% 4/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Skin and subcutaneous tissue disorders Rash maculo-papular	3.0% 1/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	6.1% 2/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Skin and subcutaneous tissue disorders Dry skin	6.1% 2/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	0.00% 0/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	6.1% 2/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Injury, poisoning and procedural complications Contusion	0.00% 0/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	6.1% 2/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Vascular disorders Hypertension	6.1% 2/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	9.1% 3/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Investigations Weight increased	6.1% 2/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	3.0% 1/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Immune system disorders Drug hypersensitivity	0.00% 0/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	6.1% 2/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Ear and labyrinth disorders Tinnitus	6.1% 2/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.	0.00% 0/33 • 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality. Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.

Additional Information

Medical Information

MorphoSys

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Results disclosure agreements

• Principal investigator is a sponsor employee No investigator or institution may publish any results of the trial conducted at their site, before a first multicentre publication is made which covers the data from all sites. The author must coordinate the publication with the sponsor, who has the right to review it at least 60 days before their submission. If publication would affect the patentability of any invention to which the sponsor has rights, the sponsor can request to delay the proposed publication for no more than 90 days.
• Publication restrictions are in place

Restriction type: OTHER