Trial Outcomes & Findings for Study of Rogaratinib (BAY1163877) vs Chemotherapy in Patients With FGFR (Fibroblast Growth Factor Receptor)-Positive Locally Advanced or Metastatic Urothelial Carcinoma (NCT NCT03410693)

NCT ID: NCT03410693

Last Updated: 2022-09-28

Results Overview

ORR is defined as the percentage of participants with complete response (CR) or partial response (PR). participants for whom overall best response is not CR or PR, as well as participants without any post-baseline tumor assessment will be considered non-responders.

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 175 participants
• Primary outcome timeframe: From start of treatment up to end of active follow-up, approximately 29 months
• Results posted on: 2022-09-28

Participant Flow

This study enrolled participants at 111centers in 28 countries from 31 MAY 2018 (first participant first visit) to 27 OCT 2020 (last participant last visit).

A total of 718 participants signed the informed consent for prescreening, of which 256 participants completed the prescreening, while 462 participants discontinued the prescreening. The discontinuations were due to screening failure (322), other reasons (98), withdrawal by the participant (22), and death (20).

Participant milestones

Measure	Rogaratinib (BAY1163877)_Overall Population Participants who were randomized to this group following a 1:1 ratio received rogaratinib 600 mg orally twice a day (b.i.d.) continuously, during a 21-day treatment cycle.	Chemotherapy_Overall Population Participants who were randomized to this group following a 1:1 ratio received chemotherapy (docetaxel, paclitaxel or vinflunine) at the discretion of the investigator, as intravenous (i.v.) infusion once every three weeks (on day 1 of a 21-day cycle).
Overall Study STARTED	87	88
Overall Study Started Treatment	86	82
Overall Study Active Follow-up Performed	61	56
Overall Study Entered Long Term Follow-up	56	69
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	87	88

Reasons for withdrawal

Measure	Rogaratinib (BAY1163877)_Overall Population Participants who were randomized to this group following a 1:1 ratio received rogaratinib 600 mg orally twice a day (b.i.d.) continuously, during a 21-day treatment cycle.	Chemotherapy_Overall Population Participants who were randomized to this group following a 1:1 ratio received chemotherapy (docetaxel, paclitaxel or vinflunine) at the discretion of the investigator, as intravenous (i.v.) infusion once every three weeks (on day 1 of a 21-day cycle).
Overall Study Disc trt: Withdrawal by participant	6	4
Overall Study Disc trt: Lost to follow up	0	1
Overall Study Disc trt: radiological progression	58	50
Overall Study Disc trt: Other	1	0
Overall Study Study drug never administered	1	6
Overall Study Discontinued (disc) treatment (trt): Death	6	4
Overall Study Disc trt: Adverse Event (AE)	13	9
Overall Study Disc trt: Physician decision	0	5
Overall Study Disc trt: clinical progression	1	5
Overall Study Disc trt:AE not asso. w/ clinical disease progress	1	4

Baseline Characteristics

Study of Rogaratinib (BAY1163877) vs Chemotherapy in Patients With FGFR (Fibroblast Growth Factor Receptor)-Positive Locally Advanced or Metastatic Urothelial Carcinoma

Baseline characteristics by cohort

Measure	Rogaratinib (BAY1163877)_Overall Population n=87 Participants Participants who were randomized to this group following a 1:1 ratio received rogaratinib 600 mg orally twice a day (b.i.d.) continuously, during a 21-day treatment cycle.	Chemotherapy_Overall Population n=88 Participants Participants who were randomized to this group following a 1:1 ratio received chemotherapy (docetaxel, paclitaxel or vinflunine) at the discretion of the investigator, as intravenous (i.v.) infusion once every three weeks (on day 1 of a 21-day cycle).	Total n=175 Participants Total of all reporting groups
Age, Continuous	67.7 years STANDARD_DEVIATION 8.3 • n=5 Participants	66.4 years STANDARD_DEVIATION 10.3 • n=7 Participants	67.0 years STANDARD_DEVIATION 9.3 • n=5 Participants
Sex: Female, Male Female	75 Participants n=5 Participants	70 Participants n=7 Participants	145 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	18 Participants n=7 Participants	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	76 Participants n=5 Participants	78 Participants n=7 Participants	154 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	23 Participants n=5 Participants	25 Participants n=7 Participants	48 Participants n=5 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
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	55 Participants n=5 Participants	55 Participants n=7 Participants	110 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Cancer Category Location of primary cancer: bladder	56 Participants n=5 Participants	45 Participants n=7 Participants	101 Participants n=5 Participants
Cancer Category Location of primary cancer: Ureter	17 Participants n=5 Participants	14 Participants n=7 Participants	31 Participants n=5 Participants
Cancer Category Location of primary cancer: Renal pelvis	12 Participants n=5 Participants	28 Participants n=7 Participants	40 Participants n=5 Participants
Cancer Category Location of primary cancer: Proximal urethra	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Cancer stage at study entry Stage III B	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Cancer stage at study entry Stage IV	5 Participants n=5 Participants	12 Participants n=7 Participants	17 Participants n=5 Participants
Cancer stage at study entry Stage IV A	13 Participants n=5 Participants	24 Participants n=7 Participants	37 Participants n=5 Participants
Cancer stage at study entry Stage IV B	67 Participants n=5 Participants	48 Participants n=7 Participants	115 Participants n=5 Participants
Cancer stage at study entry Unknown	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
PIK3CA and/or RAS activating mutations Absent	65 Participants n=5 Participants	69 Participants n=7 Participants	134 Participants n=5 Participants
PIK3CA and/or RAS activating mutations Present	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
PIK3CA and/or RAS activating mutations Unknown	12 Participants n=5 Participants	9 Participants n=7 Participants	21 Participants n=5 Participants
FGFR expression from Targos Negative	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants
FGFR expression from Targos Positive	69 Participants n=5 Participants	69 Participants n=7 Participants	138 Participants n=5 Participants
FGFR expression from Targos Not assessed	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: From start of treatment up to end of active follow-up, approximately 29 months

ORR is defined as the percentage of participants with complete response (CR) or partial response (PR). participants for whom overall best response is not CR or PR, as well as participants without any post-baseline tumor assessment will be considered non-responders.

Outcome measures

Measure	Rogaratinib (BAY1163877)_Overall Population n=87 Participants Participants who were randomized to this group following a 1:1 ratio received rogaratinib 600 mg orally twice a day (b.i.d.) continuously, during a 21-day treatment cycle.	Chemotherapy_Overall Population n=88 Participants Participants who were randomized to this group following a 1:1 ratio received chemotherapy (docetaxel, paclitaxel or vinflunine) at the discretion of the investigator, as intravenous (i.v.) infusion once every three weeks (on day 1 of a 21-day cycle).	Rogaratinib_WT Population n=62 Participants Rogaratinib arm, wild type population	Chemotherapy_WT Population n=63 Participants Chemotherapy group, wild type population
Objective Response Rate (ORR) - Central Assessment	19.5 percentage of participants Interval 11.8 to 29.4	21.6 percentage of participants Interval 13.5 to 31.6	19.4 percentage of participants Interval 10.4 to 31.4	23.8 percentage of participants Interval 14.0 to 36.2

SECONDARY outcome

Timeframe: From start of treatment till end of active follow-up, approximately 29 months

DCR was defined as the percentage of participants whose overall best response was not a progressive disease (i.e., CR, PR, stable disease [SD] or Non CR/Non PD).

Outcome measures

Measure	Rogaratinib (BAY1163877)_Overall Population n=87 Participants Participants who were randomized to this group following a 1:1 ratio received rogaratinib 600 mg orally twice a day (b.i.d.) continuously, during a 21-day treatment cycle.	Chemotherapy_Overall Population n=88 Participants Participants who were randomized to this group following a 1:1 ratio received chemotherapy (docetaxel, paclitaxel or vinflunine) at the discretion of the investigator, as intravenous (i.v.) infusion once every three weeks (on day 1 of a 21-day cycle).	Rogaratinib_WT Population n=62 Participants Rogaratinib arm, wild type population	Chemotherapy_WT Population n=63 Participants Chemotherapy group, wild type population
Disease-control Rate (DCR) - Central Assessment	50.6 percentage of participants Interval 39.6 to 61.5	55.7 percentage of participants Interval 44.7 to 66.3	53.2 percentage of participants Interval 40.1 to 66.0	63.5 percentage of participants Interval 50.4 to 75.3

SECONDARY outcome

Timeframe: From start of treatment till end of active follow-up, approximately 29 months

Progression free survival (PFS) was defined as the time (days) from randomization to date of first observed disease progression (radiological or clinical assessment or both) or death due to any cause (if death occurred before progression was documented).

Outcome measures

Measure	Rogaratinib (BAY1163877)_Overall Population n=87 Participants Participants who were randomized to this group following a 1:1 ratio received rogaratinib 600 mg orally twice a day (b.i.d.) continuously, during a 21-day treatment cycle.	Chemotherapy_Overall Population n=88 Participants Participants who were randomized to this group following a 1:1 ratio received chemotherapy (docetaxel, paclitaxel or vinflunine) at the discretion of the investigator, as intravenous (i.v.) infusion once every three weeks (on day 1 of a 21-day cycle).	Rogaratinib_WT Population n=62 Participants Rogaratinib arm, wild type population	Chemotherapy_WT Population n=63 Participants Chemotherapy group, wild type population
Progression-free Survival (PFS) - Central Assessment	2.7 months Interval 1.6 to 4.6	3.2 months Interval 2.7 to 4.4	2.8 months Interval 2.6 to 5.1	4.0 months Interval 2.8 to 6.1

SECONDARY outcome

Timeframe: From start of treatment till end of active follow-up, approximately 29 months

DOR (for patients with PR and CR only) was defined as the time from the first documented objective response of PR or CR, whichever was noted earlier, to disease progression (including symptomatic deterioration) or death, whichever was earlier

Outcome measures

Measure	Rogaratinib (BAY1163877)_Overall Population n=87 Participants Participants who were randomized to this group following a 1:1 ratio received rogaratinib 600 mg orally twice a day (b.i.d.) continuously, during a 21-day treatment cycle.	Chemotherapy_Overall Population n=88 Participants Participants who were randomized to this group following a 1:1 ratio received chemotherapy (docetaxel, paclitaxel or vinflunine) at the discretion of the investigator, as intravenous (i.v.) infusion once every three weeks (on day 1 of a 21-day cycle).	Rogaratinib_WT Population n=62 Participants Rogaratinib arm, wild type population	Chemotherapy_WT Population n=63 Participants Chemotherapy group, wild type population
Duration of Response (DOR) - Central Assessment	4.9 months Interval 2.2 to 7.0	5.8 months Interval 3.5 to 7.7	5.1 months Interval 1.5 to 9.2	7.0 months Interval 2.7 to 8.4

SECONDARY outcome

Timeframe: From start of treatment up to 30 days after the last administration of study treatment, approximately 29 months

A treatment-emergent event was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment

Outcome measures

Measure	Rogaratinib (BAY1163877)_Overall Population n=86 Participants Participants who were randomized to this group following a 1:1 ratio received rogaratinib 600 mg orally twice a day (b.i.d.) continuously, during a 21-day treatment cycle.	Chemotherapy_Overall Population n=82 Participants Participants who were randomized to this group following a 1:1 ratio received chemotherapy (docetaxel, paclitaxel or vinflunine) at the discretion of the investigator, as intravenous (i.v.) infusion once every three weeks (on day 1 of a 21-day cycle).	Rogaratinib_WT Population Rogaratinib arm, wild type population	Chemotherapy_WT Population Chemotherapy group, wild type population
Number of Participants With Treatment Emergent Adverse Events Any drug related TEAE	81 Participants	76 Participants	—	—
Number of Participants With Treatment Emergent Adverse Events Any TEAE	86 Participants	82 Participants	—	—

Adverse Events

Rogaratinib (BAY1163877)

Serious events: 39 serious events

Other events: 85 other events

Deaths: 47 deaths

Chemotherapy

Serious events: 33 serious events

Other events: 77 other events

Deaths: 45 deaths

Serious adverse events

Measure	Rogaratinib (BAY1163877) n=86 participants at risk Participants who were randomized to this group following a 1:1 ratio received rogaratinib 600 mg orally twice a day (b.i.d.) continuously, during a 21-day treatment cycle.	Chemotherapy n=82 participants at risk Participants who were randomized to this group following a 1:1 ratio received chemotherapy (docetaxel, paclitaxel or vinflunine) at the discretion of the investigator, as intravenous (i.v.) infusion once every three weeks (on day 1 of a 21-day cycle).
Investigations Lipase increased	1.2% 1/86 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	0.00% 0/82 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Metabolism and nutrition disorders Dehydration	1.2% 1/86 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	0.00% 0/82 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Metabolism and nutrition disorders Hypercalcaemia	1.2% 1/86 • Number of events 2 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	0.00% 0/82 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/86 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	1.2% 1/82 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/86 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	1.2% 1/82 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Musculoskeletal and connective tissue disorders Back pain	1.2% 1/86 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	0.00% 0/82 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	1.2% 1/86 • Number of events 2 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	0.00% 0/82 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Musculoskeletal and connective tissue disorders Osteonecrosis	1.2% 1/86 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	0.00% 0/82 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/86 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	1.2% 1/82 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Nervous system disorders Epilepsy	0.00% 0/86 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	1.2% 1/82 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Nervous system disorders Hepatic encephalopathy	1.2% 1/86 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	0.00% 0/82 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Nervous system disorders Neurotoxicity	0.00% 0/86 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	1.2% 1/82 • Number of events 2 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/86 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	1.2% 1/82 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Renal and urinary disorders Anuria	0.00% 0/86 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	1.2% 1/82 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Renal and urinary disorders Haematuria	1.2% 1/86 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	3.7% 3/82 • Number of events 4 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Renal and urinary disorders Hydronephrosis	0.00% 0/86 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	1.2% 1/82 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Renal and urinary disorders Nephritis	1.2% 1/86 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	0.00% 0/82 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Renal and urinary disorders Oliguria	0.00% 0/86 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	1.2% 1/82 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Renal and urinary disorders Haemorrhage urinary tract	0.00% 0/86 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	1.2% 1/82 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Renal and urinary disorders Postrenal failure	1.2% 1/86 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	0.00% 0/82 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Renal and urinary disorders Urinary tract obstruction	1.2% 1/86 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	1.2% 1/82 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Renal and urinary disorders Acute kidney injury	3.5% 3/86 • Number of events 4 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	2.4% 2/82 • Number of events 2 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	3.5% 3/86 • Number of events 4 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	0.00% 0/82 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Respiratory, thoracic and mediastinal disorders Emphysema	0.00% 0/86 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	1.2% 1/82 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	1.2% 1/86 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	0.00% 0/82 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/86 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	1.2% 1/82 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/86 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	1.2% 1/82 • Number of events 2 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/86 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	1.2% 1/82 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Surgical and medical procedures Ureteral stent insertion	1.2% 1/86 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	0.00% 0/82 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Blood and lymphatic system disorders Anaemia	0.00% 0/86 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	1.2% 1/82 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/86 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	4.9% 4/82 • Number of events 4 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Blood and lymphatic system disorders Neutropenia	0.00% 0/86 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	4.9% 4/82 • Number of events 6 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Blood and lymphatic system disorders Thrombocytopenia	1.2% 1/86 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	0.00% 0/82 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Cardiac disorders Acute myocardial infarction	1.2% 1/86 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	0.00% 0/82 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Cardiac disorders Cardiopulmonary failure	1.2% 1/86 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	0.00% 0/82 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Gastrointestinal disorders Abdominal pain	3.5% 3/86 • Number of events 3 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	0.00% 0/82 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Gastrointestinal disorders Colitis ischaemic	1.2% 1/86 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	0.00% 0/82 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Gastrointestinal disorders Diarrhoea	0.00% 0/86 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	2.4% 2/82 • Number of events 2 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Gastrointestinal disorders Inguinal hernia	1.2% 1/86 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	0.00% 0/82 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Gastrointestinal disorders Intestinal obstruction	1.2% 1/86 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	0.00% 0/82 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Gastrointestinal disorders Intussusception	1.2% 1/86 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	0.00% 0/82 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Gastrointestinal disorders Nausea	1.2% 1/86 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	0.00% 0/82 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Gastrointestinal disorders Pancreatitis	1.2% 1/86 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	0.00% 0/82 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Gastrointestinal disorders Small intestinal obstruction	1.2% 1/86 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	0.00% 0/82 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Gastrointestinal disorders Volvulus	1.2% 1/86 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	0.00% 0/82 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Gastrointestinal disorders Vomiting	1.2% 1/86 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	1.2% 1/82 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
General disorders Asthenia	1.2% 1/86 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	0.00% 0/82 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
General disorders Condition aggravated	2.3% 2/86 • Number of events 2 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	0.00% 0/82 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
General disorders Death	4.7% 4/86 • Number of events 4 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	2.4% 2/82 • Number of events 2 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
General disorders Mucosal inflammation	1.2% 1/86 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	0.00% 0/82 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
General disorders Oedema peripheral	0.00% 0/86 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	1.2% 1/82 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
General disorders Pain	1.2% 1/86 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	0.00% 0/82 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
General disorders Pyrexia	1.2% 1/86 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	1.2% 1/82 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
General disorders General physical health deterioration	4.7% 4/86 • Number of events 6 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	1.2% 1/82 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
General disorders Multiple organ dysfunction syndrome	1.2% 1/86 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	0.00% 0/82 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Hepatobiliary disorders Cholecystitis	1.2% 1/86 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	0.00% 0/82 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Hepatobiliary disorders Cholelithiasis	1.2% 1/86 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	0.00% 0/82 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Hepatobiliary disorders Hepatic failure	1.2% 1/86 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	0.00% 0/82 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Infections and infestations Bronchitis	0.00% 0/86 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	1.2% 1/82 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Infections and infestations Cellulitis	1.2% 1/86 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	2.4% 2/82 • Number of events 2 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Infections and infestations Pneumonia	0.00% 0/86 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	2.4% 2/82 • Number of events 2 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Infections and infestations Relapsing fever	1.2% 1/86 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	0.00% 0/82 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Infections and infestations Sepsis	0.00% 0/86 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	3.7% 3/82 • Number of events 3 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Infections and infestations Urinary tract infection	1.2% 1/86 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	4.9% 4/82 • Number of events 4 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Infections and infestations Wound infection	1.2% 1/86 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	0.00% 0/82 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Infections and infestations Urosepsis	1.2% 1/86 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	2.4% 2/82 • Number of events 2 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Infections and infestations Groin infection	0.00% 0/86 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	1.2% 1/82 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Infections and infestations Klebsiella infection	0.00% 0/86 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	1.2% 1/82 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Infections and infestations Respiratory tract infection	0.00% 0/86 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	1.2% 1/82 • Number of events 2 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Infections and infestations Device related infection	1.2% 1/86 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	0.00% 0/82 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Infections and infestations Pneumocystis jirovecii pneumonia	0.00% 0/86 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	1.2% 1/82 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Infections and infestations Escherichia pyelonephritis	0.00% 0/86 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	1.2% 1/82 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Injury, poisoning and procedural complications Fall	1.2% 1/86 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	1.2% 1/82 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/86 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	1.2% 1/82 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Injury, poisoning and procedural complications Hip fracture	1.2% 1/86 • Number of events 2 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	0.00% 0/82 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Injury, poisoning and procedural complications Periprosthetic fracture	1.2% 1/86 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	0.00% 0/82 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Investigations Aspartate aminotransferase increased	1.2% 1/86 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	0.00% 0/82 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Investigations Biopsy liver	1.2% 1/86 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	0.00% 0/82 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Investigations Blood creatinine increased	2.3% 2/86 • Number of events 7 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	0.00% 0/82 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.

Other adverse events

Measure	Rogaratinib (BAY1163877) n=86 participants at risk Participants who were randomized to this group following a 1:1 ratio received rogaratinib 600 mg orally twice a day (b.i.d.) continuously, during a 21-day treatment cycle.	Chemotherapy n=82 participants at risk Participants who were randomized to this group following a 1:1 ratio received chemotherapy (docetaxel, paclitaxel or vinflunine) at the discretion of the investigator, as intravenous (i.v.) infusion once every three weeks (on day 1 of a 21-day cycle).
Investigations Aspartate aminotransferase increased	11.6% 10/86 • Number of events 16 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	2.4% 2/82 • Number of events 3 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Investigations Blood creatinine increased	12.8% 11/86 • Number of events 18 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	3.7% 3/82 • Number of events 6 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Investigations Gamma-glutamyltransferase increased	5.8% 5/86 • Number of events 6 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	0.00% 0/82 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Investigations Lipase increased	10.5% 9/86 • Number of events 25 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	3.7% 3/82 • Number of events 11 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Investigations Neutrophil count decreased	0.00% 0/86 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	17.1% 14/82 • Number of events 22 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Investigations White blood cell count decreased	0.00% 0/86 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	6.1% 5/82 • Number of events 5 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Investigations Blood alkaline phosphatase increased	14.0% 12/86 • Number of events 14 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	2.4% 2/82 • Number of events 3 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Investigations Calcium phosphate product increased	9.3% 8/86 • Number of events 10 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	0.00% 0/82 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Metabolism and nutrition disorders Hyperkalaemia	9.3% 8/86 • Number of events 11 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	7.3% 6/82 • Number of events 14 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Metabolism and nutrition disorders Hyperphosphataemia	45.3% 39/86 • Number of events 79 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	0.00% 0/82 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Metabolism and nutrition disorders Hyponatraemia	7.0% 6/86 • Number of events 9 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	6.1% 5/82 • Number of events 7 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Metabolism and nutrition disorders Decreased appetite	41.9% 36/86 • Number of events 55 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	25.6% 21/82 • Number of events 25 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Investigations Weight decreased	11.6% 10/86 • Number of events 11 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	7.3% 6/82 • Number of events 7 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	10.5% 9/86 • Number of events 12 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	8.5% 7/82 • Number of events 7 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Musculoskeletal and connective tissue disorders Back pain	9.3% 8/86 • Number of events 8 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	9.8% 8/82 • Number of events 9 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Musculoskeletal and connective tissue disorders Myalgia	5.8% 5/86 • Number of events 6 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	12.2% 10/82 • Number of events 12 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	8.1% 7/86 • Number of events 10 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	4.9% 4/82 • Number of events 4 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Nervous system disorders Dysgeusia	15.1% 13/86 • Number of events 14 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	6.1% 5/82 • Number of events 6 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Nervous system disorders Headache	7.0% 6/86 • Number of events 7 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	4.9% 4/82 • Number of events 5 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Nervous system disorders Neuropathy peripheral	3.5% 3/86 • Number of events 4 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	12.2% 10/82 • Number of events 12 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Nervous system disorders Peripheral sensory neuropathy	1.2% 1/86 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	12.2% 10/82 • Number of events 14 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Psychiatric disorders Insomnia	5.8% 5/86 • Number of events 5 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	4.9% 4/82 • Number of events 4 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Renal and urinary disorders Haematuria	10.5% 9/86 • Number of events 13 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	7.3% 6/82 • Number of events 8 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Respiratory, thoracic and mediastinal disorders Cough	4.7% 4/86 • Number of events 6 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	7.3% 6/82 • Number of events 7 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	3.5% 3/86 • Number of events 3 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	6.1% 5/82 • Number of events 6 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Respiratory, thoracic and mediastinal disorders Epistaxis	11.6% 10/86 • Number of events 10 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	1.2% 1/82 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Skin and subcutaneous tissue disorders Alopecia	23.3% 20/86 • Number of events 23 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	29.3% 24/82 • Number of events 26 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Skin and subcutaneous tissue disorders Dry skin	8.1% 7/86 • Number of events 9 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	2.4% 2/82 • Number of events 2 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Skin and subcutaneous tissue disorders Nail discolouration	7.0% 6/86 • Number of events 8 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	0.00% 0/82 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Skin and subcutaneous tissue disorders Rash	8.1% 7/86 • Number of events 9 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	3.7% 3/82 • Number of events 5 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Skin and subcutaneous tissue disorders Onychomadesis	8.1% 7/86 • Number of events 8 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	0.00% 0/82 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Skin and subcutaneous tissue disorders Nail toxicity	8.1% 7/86 • Number of events 12 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	0.00% 0/82 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Vascular disorders Hypotension	7.0% 6/86 • Number of events 6 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	1.2% 1/82 • Number of events 1 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	8.1% 7/86 • Number of events 10 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	0.00% 0/82 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Blood and lymphatic system disorders Anaemia	12.8% 11/86 • Number of events 17 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	34.1% 28/82 • Number of events 66 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Blood and lymphatic system disorders Neutropenia	3.5% 3/86 • Number of events 6 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	23.2% 19/82 • Number of events 30 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Eye disorders Dry eye	5.8% 5/86 • Number of events 5 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	3.7% 3/82 • Number of events 3 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Eye disorders Detachment of retinal pigment epithelium	8.1% 7/86 • Number of events 16 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	0.00% 0/82 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Eye disorders Subretinal fluid	8.1% 7/86 • Number of events 8 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	0.00% 0/82 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Gastrointestinal disorders Abdominal pain	17.4% 15/86 • Number of events 18 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	15.9% 13/82 • Number of events 27 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Gastrointestinal disorders Constipation	29.1% 25/86 • Number of events 31 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	35.4% 29/82 • Number of events 54 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Gastrointestinal disorders Diarrhoea	55.8% 48/86 • Number of events 92 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	22.0% 18/82 • Number of events 19 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Gastrointestinal disorders Dry mouth	11.6% 10/86 • Number of events 15 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	2.4% 2/82 • Number of events 2 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Gastrointestinal disorders Mouth ulceration	5.8% 5/86 • Number of events 7 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	3.7% 3/82 • Number of events 3 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Gastrointestinal disorders Nausea	31.4% 27/86 • Number of events 38 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	24.4% 20/82 • Number of events 38 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Gastrointestinal disorders Stomatitis	11.6% 10/86 • Number of events 15 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	12.2% 10/82 • Number of events 14 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Gastrointestinal disorders Vomiting	17.4% 15/86 • Number of events 19 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	22.0% 18/82 • Number of events 26 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
General disorders Asthenia	29.1% 25/86 • Number of events 52 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	23.2% 19/82 • Number of events 40 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
General disorders Fatigue	24.4% 21/86 • Number of events 32 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	34.1% 28/82 • Number of events 41 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
General disorders Mucosal inflammation	8.1% 7/86 • Number of events 20 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	9.8% 8/82 • Number of events 12 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
General disorders Oedema peripheral	9.3% 8/86 • Number of events 9 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	12.2% 10/82 • Number of events 13 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
General disorders Pyrexia	14.0% 12/86 • Number of events 15 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	12.2% 10/82 • Number of events 14 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Infections and infestations Conjunctivitis	5.8% 5/86 • Number of events 8 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	3.7% 3/82 • Number of events 3 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Infections and infestations Influenza	5.8% 5/86 • Number of events 5 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	0.00% 0/82 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Infections and infestations Paronychia	8.1% 7/86 • Number of events 8 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	0.00% 0/82 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Infections and infestations Urinary tract infection	14.0% 12/86 • Number of events 12 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	9.8% 8/82 • Number of events 13 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
Investigations Alanine aminotransferase increased	15.1% 13/86 • Number of events 22 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.	2.4% 2/82 • Number of events 4 • Approximately 29 months A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.

Additional Information

Therapeutic Area Head

Bayer

Phone: (+) 1-888-8422937

Email: clinical-trials-contact@bayer.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER