Trial Outcomes & Findings for SENS-401 to Prevent the Ototoxicity Induced by Cisplatin in Adult Subjects With a Neoplastic Disease (NCT NCT05628233)

Last Updated: 2026-07-02

Results Overview

Pure tone audiometry (PTA) is a behavioral, subjective hearing test used to assess an individual's hearing threshold levels measured in decibels (dB) and determine the degree of hearing loss. A decrease of hearing threshold is considered as an improvement and an increase as a deterioration of the audition. PTA assessments were conducted at Baseline (prior to the first dose of cisplatin), 4 weeks and 12 weeks after the completion of cisplatin treatment for all participants (Arms A and B). The change in hearing threshold from baseline was evaluated at the average across three contiguous hearing frequencies (8-10-12.5 kHz) using PTA.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

48 participants

Primary outcome timeframe

4 weeks after the completion of cisplatin treatment

Results posted on

2026-07-02

Participant Flow

Participant milestones

Participant milestones
Measure	Arm A (Control Arm) Subjects receiving cisplatin-based chemotherapy without receiving SENS-401. This control arm provided natural history data, particularly on the incidence and the time to onset of hearing impairment due to ototoxicity.	Arm B (Treatment Arm) Subjects receiving 43.5 mg of oral SENS-401 b.i.d for up to 23 weeks. This arm provided data on the potential protective effects of SENS-401 on cisplatin induced ototoxicity. SENS-401 (R-Azasetron Besylate): Patients received SENS-401 ((R)-azasetron besylate) B.I.D. up to 23 weeks: 1 week prior to the initiation of the cisplatin treatment, during the whole duration of the chemotherapy treatment (estimated to last up to 18 weeks) and 4 weeks after stopping chemotherapy.
Overall Study STARTED	24	24
Overall Study COMPLETED	16	19
Overall Study NOT COMPLETED	8	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A (Control Arm) Subjects receiving cisplatin-based chemotherapy without receiving SENS-401. This control arm provided natural history data, particularly on the incidence and the time to onset of hearing impairment due to ototoxicity.	Arm B (Treatment Arm) Subjects receiving 43.5 mg of oral SENS-401 b.i.d for up to 23 weeks. This arm provided data on the potential protective effects of SENS-401 on cisplatin induced ototoxicity. SENS-401 (R-Azasetron Besylate): Patients received SENS-401 ((R)-azasetron besylate) B.I.D. up to 23 weeks: 1 week prior to the initiation of the cisplatin treatment, during the whole duration of the chemotherapy treatment (estimated to last up to 18 weeks) and 4 weeks after stopping chemotherapy.
Overall Study Withdrawal by Subject	7	1
Overall Study Physician Decision	1	4

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A (Control Arm) n=24 Participants Subjects receiving cisplatin-based chemotherapy without receiving SENS-401. This control arm provided natural history data, particularly on the incidence and the time to onset of hearing impairment due to ototoxicity.	Arm B (Treatment Arm) n=23 Participants Subjects receiving 43.5 mg of oral SENS-401 b.i.d for up to 23 weeks. This arm provided data on the potential protective effects of SENS-401 on cisplatin induced ototoxicity. SENS-401 (R-Azasetron Besylate): Patients received SENS-401 ((R)-azasetron besylate) B.I.D. up to 23 weeks: 1 week prior to the initiation of the cisplatin treatment, during the whole duration of the chemotherapy treatment (estimated to last up to 18 weeks) and 4 weeks after stopping chemotherapy.	Total n=47 Participants Total of all reporting groups
Age, Continuous	55.5 years STANDARD_DEVIATION 11 • n=24 Participants	56.9 years STANDARD_DEVIATION 13.6 • n=23 Participants	56.2 years STANDARD_DEVIATION 12.3 • n=47 Participants
Sex: Female, Male Female	4 Participants n=24 Participants	4 Participants n=23 Participants	8 Participants n=47 Participants
Sex: Female, Male Male	20 Participants n=24 Participants	19 Participants n=23 Participants	39 Participants n=47 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment France	22 Participants n=24 Participants	21 Participants n=23 Participants	43 Participants n=47 Participants
Region of Enrollment Israel	2 Participants n=24 Participants	2 Participants n=23 Participants	4 Participants n=47 Participants

PRIMARY outcome

Timeframe: 4 weeks after the completion of cisplatin treatment

Population: The Full Analysis Set (FAS) population was extended to the eligible ears of the randomized subjects for the primary analysis.

Outcome measures

Outcome measures
Measure	Arm A (Control Arm) n=29 Number of eligible ears Subjects receiving cisplatin-based chemotherapy without receiving SENS-401. This control arm provided natural history data, particularly on the incidence and the time to onset of hearing impairment due to ototoxicity.	Arm B (Treatment Arm) n=26 Number of eligible ears Subjects receiving 43.5 mg of oral SENS-401 b.i.d for up to 23 weeks. This arm provided data on the potential protective effects of SENS-401 on cisplatin induced ototoxicity. SENS-401 (R-Azasetron Besylate): Patients received SENS-401 ((R)-azasetron besylate) B.I.D. up to 23 weeks: 1 week prior to the initiation of the cisplatin treatment, during the whole duration of the chemotherapy treatment (estimated to last up to 18 weeks) and 4 weeks after stopping chemotherapy.
SENS-401 Efficacy Assessment With Change From Baseline of the Average of the Hearing Threshold 4 Weeks After the Completion of Cisplatin Treatment in Each Eligible Ear of Each Subject	13.2 dB Standard Error 2.8	16.8 dB Standard Error 2.8

SECONDARY outcome

Timeframe: 12 weeks after the completion of cisplatin treatment

Outcome measures

Outcome measures
Measure	Arm A (Control Arm) n=28 Number of eligible ears Subjects receiving cisplatin-based chemotherapy without receiving SENS-401. This control arm provided natural history data, particularly on the incidence and the time to onset of hearing impairment due to ototoxicity.	Arm B (Treatment Arm) n=32 Number of eligible ears Subjects receiving 43.5 mg of oral SENS-401 b.i.d for up to 23 weeks. This arm provided data on the potential protective effects of SENS-401 on cisplatin induced ototoxicity. SENS-401 (R-Azasetron Besylate): Patients received SENS-401 ((R)-azasetron besylate) B.I.D. up to 23 weeks: 1 week prior to the initiation of the cisplatin treatment, during the whole duration of the chemotherapy treatment (estimated to last up to 18 weeks) and 4 weeks after stopping chemotherapy.
SENS-401 Efficacy Assessment With Change From Baseline of the Average of the Hearing Threshold 12 Weeks After the Completion of Cisplatin Treatment in Each Eligible Ear of Each Subject.	10 dB Standard Error 2.8	14.9 dB Standard Error 2.5

Adverse Events

Arm A (Control Arm)

Serious events: 8 serious events

Other events: 20 other events

Deaths: 0 deaths

Arm B (Treatment Arm)

Serious events: 15 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Head of Medical

Sensorion

Phone: +33686831180

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The PI must in advance inform and provide to the sponsor a copy of the proposed publication. The sponsor may request that the PI remove confidential information from the publication.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	Arm A (Control Arm) n=24 participants at risk Subjects receiving cisplatin-based chemotherapy without receiving SENS-401. This control arm provided natural history data, particularly on the incidence and the time to onset of hearing impairment due to ototoxicity.	Arm B (Treatment Arm) n=23 participants at risk Subjects receiving 43.5 mg of oral SENS-401 b.i.d for up to 23 weeks. This arm provided data on the potential protective effects of SENS-401 on cisplatin induced ototoxicity. SENS-401 (R-Azasetron Besylate): Patients received SENS-401 ((R)-azasetron besylate) B.I.D. up to 23 weeks: 1 week prior to the initiation of the cisplatin treatment, during the whole duration of the chemotherapy treatment (estimated to last up to 18 weeks) and 4 weeks after stopping chemotherapy.
Blood and lymphatic system disorders Anaemia	0.00% 0/24 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).	4.3% 1/23 • Number of events 1 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).
Blood and lymphatic system disorders Febrile bone marrow aplasia	4.2% 1/24 • Number of events 1 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).	4.3% 1/23 • Number of events 1 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/24 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).	4.3% 1/23 • Number of events 1 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).
Blood and lymphatic system disorders Neutropenia	4.2% 1/24 • Number of events 1 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).	4.3% 1/23 • Number of events 1 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/24 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).	4.3% 1/23 • Number of events 1 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).
Cardiac disorders Myocardial infarction	4.2% 1/24 • Number of events 1 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).	0.00% 0/23 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).
Gastrointestinal disorders Abdominal pain	0.00% 0/24 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).	4.3% 1/23 • Number of events 1 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).
Gastrointestinal disorders Colitis	0.00% 0/24 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).	4.3% 1/23 • Number of events 1 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).
Gastrointestinal disorders Dysphagia	4.2% 1/24 • Number of events 1 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).	0.00% 0/23 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).
Gastrointestinal disorders Mouth haemorrhage	4.2% 1/24 • Number of events 1 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).	0.00% 0/23 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).
Gastrointestinal disorders Nausea	4.2% 1/24 • Number of events 1 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).	0.00% 0/23 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).
Gastrointestinal disorders Vomiting	12.5% 3/24 • Number of events 3 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).	0.00% 0/23 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).
General disorders Pain	0.00% 0/24 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).	4.3% 1/23 • Number of events 1 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).
Infections and infestations Device related infection	0.00% 0/24 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).	4.3% 1/23 • Number of events 1 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).
Infections and infestations Pyelonephritis	4.2% 1/24 • Number of events 1 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).	0.00% 0/23 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).
Investigations Neutrophil count decreased	0.00% 0/24 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).	13.0% 3/23 • Number of events 4 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).
Metabolism and nutrition disorders Decreased appetite	0.00% 0/24 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).	8.7% 2/23 • Number of events 2 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).
Renal and urinary disorders Acute kidney injury	0.00% 0/24 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).	13.0% 3/23 • Number of events 3 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).
Renal and urinary disorders Bladder perforation	4.2% 1/24 • Number of events 1 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).	0.00% 0/23 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).
Renal and urinary disorders Renal failure	4.2% 1/24 • Number of events 1 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).	0.00% 0/23 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).
Respiratory, thoracic and mediastinal disorders Lung disorder	0.00% 0/24 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).	4.3% 1/23 • Number of events 1 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/24 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).	4.3% 1/23 • Number of events 1 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	4.2% 1/24 • Number of events 1 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).	0.00% 0/23 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).

Other adverse events
Measure	Arm A (Control Arm) n=24 participants at risk Subjects receiving cisplatin-based chemotherapy without receiving SENS-401. This control arm provided natural history data, particularly on the incidence and the time to onset of hearing impairment due to ototoxicity.	Arm B (Treatment Arm) n=23 participants at risk Subjects receiving 43.5 mg of oral SENS-401 b.i.d for up to 23 weeks. This arm provided data on the potential protective effects of SENS-401 on cisplatin induced ototoxicity. SENS-401 (R-Azasetron Besylate): Patients received SENS-401 ((R)-azasetron besylate) B.I.D. up to 23 weeks: 1 week prior to the initiation of the cisplatin treatment, during the whole duration of the chemotherapy treatment (estimated to last up to 18 weeks) and 4 weeks after stopping chemotherapy.
Blood and lymphatic system disorders Anaemia	16.7% 4/24 • Number of events 4 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).	39.1% 9/23 • Number of events 15 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).
Blood and lymphatic system disorders Lymphopenia	12.5% 3/24 • Number of events 10 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).	8.7% 2/23 • Number of events 3 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).
Blood and lymphatic system disorders Neutropenia	12.5% 3/24 • Number of events 3 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).	26.1% 6/23 • Number of events 6 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).
Blood and lymphatic system disorders Thrombocytopenia	8.3% 2/24 • Number of events 2 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).	4.3% 1/23 • Number of events 2 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).
Ear and labyrinth disorders Hypoacusis	4.2% 1/24 • Number of events 1 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).	8.7% 2/23 • Number of events 2 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).
Ear and labyrinth disorders Tinnitus	29.2% 7/24 • Number of events 8 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).	30.4% 7/23 • Number of events 7 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).
Gastrointestinal disorders Abdominal pain upper	0.00% 0/24 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).	8.7% 2/23 • Number of events 2 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).
Gastrointestinal disorders Constipation	29.2% 7/24 • Number of events 7 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).	34.8% 8/23 • Number of events 10 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).
Gastrointestinal disorders Diarrhoea	0.00% 0/24 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).	17.4% 4/23 • Number of events 4 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).
Gastrointestinal disorders Dry mouth	8.3% 2/24 • Number of events 3 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).	13.0% 3/23 • Number of events 3 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).
Gastrointestinal disorders Dysphagia	12.5% 3/24 • Number of events 6 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).	17.4% 4/23 • Number of events 8 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).
Gastrointestinal disorders Nausea	45.8% 11/24 • Number of events 13 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).	43.5% 10/23 • Number of events 15 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).
Gastrointestinal disorders Odynophagia	8.3% 2/24 • Number of events 2 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).	4.3% 1/23 • Number of events 1 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).
Gastrointestinal disorders Stomatitis	0.00% 0/24 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).	8.7% 2/23 • Number of events 3 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).
Gastrointestinal disorders Vomiting	8.3% 2/24 • Number of events 2 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).	13.0% 3/23 • Number of events 4 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).
General disorders Asthenia	33.3% 8/24 • Number of events 11 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).	56.5% 13/23 • Number of events 20 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).
General disorders Fatigue	8.3% 2/24 • Number of events 2 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).	8.7% 2/23 • Number of events 3 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).
General disorders Mucosal inflammation	20.8% 5/24 • Number of events 16 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).	30.4% 7/23 • Number of events 20 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).
General disorders Pyrexia	0.00% 0/24 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).	13.0% 3/23 • Number of events 5 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).
Infections and infestations Tongue fungal infection	4.2% 1/24 • Number of events 1 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).	8.7% 2/23 • Number of events 2 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).
Injury, poisoning and procedural complications Radiation skin injury	16.7% 4/24 • Number of events 10 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).	13.0% 3/23 • Number of events 4 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).
Investigations Alanine aminotransferase increased	4.2% 1/24 • Number of events 1 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).	8.7% 2/23 • Number of events 2 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).
Investigations Aspartate aminotransferase increased	4.2% 1/24 • Number of events 1 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).	8.7% 2/23 • Number of events 2 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).
Investigations Blood creatinine increased	4.2% 1/24 • Number of events 2 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).	8.7% 2/23 • Number of events 6 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).
Investigations Lymphocyte count decreased	4.2% 1/24 • Number of events 1 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).	17.4% 4/23 • Number of events 4 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).
Investigations Weight decreased	0.00% 0/24 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).	13.0% 3/23 • Number of events 3 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).
Metabolism and nutrition disorders Decreased appetite	4.2% 1/24 • Number of events 1 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).	21.7% 5/23 • Number of events 6 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/24 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).	17.4% 4/23 • Number of events 4 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/24 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).	8.7% 2/23 • Number of events 2 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).
Metabolism and nutrition disorders Hypophosphataemia	12.5% 3/24 • Number of events 3 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).	0.00% 0/23 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).
Metabolism and nutrition disorders Malnutrition	8.3% 2/24 • Number of events 2 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).	4.3% 1/23 • Number of events 1 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).
Nervous system disorders Diziness	0.00% 0/24 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).	8.7% 2/23 • Number of events 2 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).
Nervous system disorders Dysgeusia	12.5% 3/24 • Number of events 3 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).	17.4% 4/23 • Number of events 4 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).
Nervous system disorders Headache	8.3% 2/24 • Number of events 2 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).	4.3% 1/23 • Number of events 1 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).
Nervous system disorders Neuropathy peripheral	0.00% 0/24 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).	13.0% 3/23 • Number of events 3 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).
Renal and urinary disorders Acute kidney injury	4.2% 1/24 • Number of events 1 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).	13.0% 3/23 • Number of events 3 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).
Renal and urinary disorders Haematuria	0.00% 0/24 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).	8.7% 2/23 • Number of events 2 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).
Renal and urinary disorders Renal failure	4.2% 1/24 • Number of events 1 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).	8.7% 2/23 • Number of events 2 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).
Respiratory, thoracic and mediastinal disorders Cough	4.2% 1/24 • Number of events 1 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).	8.7% 2/23 • Number of events 3 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).
Respiratory, thoracic and mediastinal disorders Dyspnoea	4.2% 1/24 • Number of events 1 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).	13.0% 3/23 • Number of events 3 • From enrollment until end of follow-up (up to 31 weeks) Other adverse events reported below are Treatment Emergent Adverse Events defined as follow: AEs that first occurred or worsened in severity after the first administration of study treatment (SENS-401 or cisplatin-based chemotherapy) and prior to 30 days after the last administration of study treatment. Safety analyses were performed on the Safety Set, defined as the randomized subjects who received any treatment (either cisplatin-based chemotherapy alone or with SENS-401).