Trial Outcomes & Findings for Consolidation Therapy With Hu3S193 for Women With Ovarian, Primary Peritoneal or Fallopian Tube Cancer (NCT NCT01137071)

NCT ID: NCT01137071

Last Updated: 2017-02-23

Results Overview

PFS2 is defined by the interval from the beginning of rescue platinum-based chemotherapy until documented disease progression or death for any cause while the patient was under study or during the prolonged follow-up period. Disease progression is defined by appearance of any new lesion (measurable and non-measurable) by the RECIST criteria. Disease progression date is the date when a new lesion is documented.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 29 participants
• Primary outcome timeframe: 1-Year - From platinum-based rescue chemotherapy start date until documented disease progression or death of any cause whichever occurred first.
• Results posted on: 2017-02-23

Participant Flow

This was a Brazilian, multicentric clinical trial. From April 12, 2011 to October 31, 2013 a total of 37 patients were screened for this study, of whom 29 received at least one dose of the investigational product and 07 were considered noneligible.

Patients were considered included in the study on the day of the first investigational product administration after investigator assured that patients met all the inclusion criterions and none of the exclusion criterions.

Participant milestones

Measure	hu3S193 hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Overall Study STARTED	29
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Measure	hu3S193 hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Overall Study Disease Progression	11
Overall Study Withdrawal by Subject	2
Overall Study Wrongly Included	1

Baseline Characteristics

Consolidation Therapy With Hu3S193 for Women With Ovarian, Primary Peritoneal or Fallopian Tube Cancer

Baseline characteristics by cohort

Measure	Monoclonal Antibody hu3S193 n=29 Participants hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Age, Continuous	55.69 Years n=5 Participants
Gender Female	29 Participants n=5 Participants
Gender Male	0 Participants n=5 Participants
Race/Ethnicity, Customized White	24 participants n=5 Participants
Race/Ethnicity, Customized Black	1 participants n=5 Participants
Race/Ethnicity, Customized Yellow	0 participants n=5 Participants
Race/Ethnicity, Customized Brown	4 participants n=5 Participants
Race/Ethnicity, Customized Other	0 participants n=5 Participants
Region of Enrollment Brazil	29 participants n=5 Participants

PRIMARY outcome

Timeframe: 1-Year - From platinum-based rescue chemotherapy start date until documented disease progression or death of any cause whichever occurred first.

Population: In the ITT (intention to treat) population, 25 patients out of the 29 considered for the PFS2 analysis presented disease progression or death and 4 were censored. The median time to disease progression or death was 11.8 months (95% CI (confidence interval), 10.6 to 13.9 months).

PFS2 is defined by the interval from the beginning of rescue platinum-based chemotherapy until documented disease progression or death for any cause while the patient was under study or during the prolonged follow-up period.

Disease progression is defined by appearance of any new lesion (measurable and non-measurable) by the RECIST criteria. Disease progression date is the date when a new lesion is documented.

Outcome measures

Measure	hu3S193 n=29 Participants hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
1-year PFS2 Rate After the Beginning of Rescue Platinum-based Chemotherapy	11.7614 Months Interval 10.5902 to 13.9251

SECONDARY outcome

Timeframe: 1 year from the beginning of platinum-based rescue chemotherapy start date

Population: In the ITT (Intention-to-treat) population, 25 patients out of the 29 considered for the PFS2 analysis presented disease progression or death and 4 were censored.

Outcome measures

Measure	hu3S193 n=29 Participants hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
1-year Disease Progression-free Survival Rate	48.2 percentage of participants

SECONDARY outcome

Timeframe: 2-year overall survival rate after the beginning of rescue platinum-based chemotherapy.

Population: Within the ITT population, 7 patients died and 22 were censored. The 2-year overall survival rate was 70.7%.

Overall survival was calculated as the time interval between the date of beginning of rescue platinum-based chemotherapy and date of death for any cause.

Outcome measures

Measure	hu3S193 n=29 Participants hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Two-year Overall Survival Rate	70.7 percentage of participants

SECONDARY outcome

Timeframe: Baseline, week 2 , week 4 and week 27

Population: All patients enrolled in this study received at least one dose of Hu3S193 (30 mg/m2) - ITT dataset. Baseline n=29, week 2 n=27, week 4 n= 28, week 27 n= 14

Vital signs were assessed throughout the study treatment (consolidation therapy).Through study completion, an average of 27 weeks.

Outcome measures

Measure	hu3S193 n=29 Participants hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Safety - Vital Signs - Heart Rate Week 4	76.00 bpm Standard Deviation 10.58
Safety - Vital Signs - Heart Rate Baseline	78.00 bpm Standard Deviation 12.11
Safety - Vital Signs - Heart Rate Week 2	80.00 bpm Standard Deviation 11.49
Safety - Vital Signs - Heart Rate Week 27	75.00 bpm Standard Deviation 9.84

SECONDARY outcome

Timeframe: Baseline, week 2, week 4 and week 27

Population: All patients enrolled in this study received at least one dose of Hu3S193 (30 mg/m2) - ITT dataset. Baseline n=29, week 2 n=27, week 4 n= 28, week 27 n= 14

Vital signs during the study treatment (consolidation therapy). Through study completion, an average of 27 weeks.

Outcome measures

Measure	hu3S193 n=29 Participants hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Safety - Vital Signs - Respiratory Rate Baseline	19.00 ipm (Incursions per minute) Standard Deviation 2.10
Safety - Vital Signs - Respiratory Rate Week 2	19.00 ipm (Incursions per minute) Standard Deviation 1.62
Safety - Vital Signs - Respiratory Rate Week 4	19.00 ipm (Incursions per minute) Standard Deviation 1.59
Safety - Vital Signs - Respiratory Rate Week 27	19.00 ipm (Incursions per minute) Standard Deviation 1.86

SECONDARY outcome

Timeframe: Baseline, week 2, week 4 and week 27

Population: All patients enrolled in this study received at least one dose of Hu3S193 (30 mg/m2) - ITT dataset. Diastolic Baseline n=29, week 2 n=27, week 4 n= 28, week 27 n= 14/ Systolic Baseline n=28, week 2 n=27, week 4 n= 28, week 27 n= 14

Both parameters were assessed throughout the study treatment. Vital signs during the study treatment (consolidation therapy). Through study completion, an average of 27 weeks.

Outcome measures

Measure	hu3S193 n=29 Participants hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Safety - Vital Signs - Systolic and Diastolic Blood Pressure Diastolic Baseline	80.00 mmHg Standard Deviation 8.88
Safety - Vital Signs - Systolic and Diastolic Blood Pressure Diastolic Week 2	77.00 mmHg Standard Deviation 9.04
Safety - Vital Signs - Systolic and Diastolic Blood Pressure Diastolic Week 4	70.00 mmHg Standard Deviation 7.92
Safety - Vital Signs - Systolic and Diastolic Blood Pressure Diastolic Week 27	80.00 mmHg Standard Deviation 8.63
Safety - Vital Signs - Systolic and Diastolic Blood Pressure Systolic Baseline	115.00 mmHg Standard Deviation 15.93
Safety - Vital Signs - Systolic and Diastolic Blood Pressure Systolic Week 2	110.00 mmHg Standard Deviation 14.79
Safety - Vital Signs - Systolic and Diastolic Blood Pressure Systolic Week 4	118.00 mmHg Standard Deviation 11.32
Safety - Vital Signs - Systolic and Diastolic Blood Pressure Systolic Week 27	120.00 mmHg Standard Deviation 13.00

SECONDARY outcome

Timeframe: Baseline, week 2, week 4 and week 27

Population: All patients enrolled in this study received at least one dose of Hu3S193 (30 mg/m2) - ITT dataset. Baseline n=29, week 2 n=27, week 4 n= 28, week 27 n= 14

Vital signs during the study treatment (consolidation therapy). Through study completion, an average of 27 weeks.

Outcome measures

Measure	hu3S193 n=29 Participants hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Safety - Vital Signs - Temperature Baseline	36.00 °C Standard Deviation 0.41
Safety - Vital Signs - Temperature Week 2	36.00 °C Standard Deviation 0.50
Safety - Vital Signs - Temperature Week 4	35.90 °C Standard Deviation 0.43
Safety - Vital Signs - Temperature Week 27	35.70 °C Standard Deviation 0.51

SECONDARY outcome

Timeframe: From the first infusion of medication to 30 days after the last one

Population: All patients who received at least one dose of investigational product were included in the safety dataset.

The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.

Outcome measures

Measure	hu3S193 n=29 Participants hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Incidence of Adverse Events (AEs) - Gastrointestinal Disorders Nausea	19 Incidence
Incidence of Adverse Events (AEs) - Gastrointestinal Disorders Vomiting	17 Incidence
Incidence of Adverse Events (AEs) - Gastrointestinal Disorders Abdominal pain	9 Incidence
Incidence of Adverse Events (AEs) - Gastrointestinal Disorders Constipation	7 Incidence
Incidence of Adverse Events (AEs) - Gastrointestinal Disorders Diarrhoea	6 Incidence
Incidence of Adverse Events (AEs) - Gastrointestinal Disorders Abdominal pain upper	3 Incidence
Incidence of Adverse Events (AEs) - Gastrointestinal Disorders Dry Mouth	2 Incidence
Incidence of Adverse Events (AEs) - Gastrointestinal Disorders Dyspepsia	2 Incidence
Incidence of Adverse Events (AEs) - Gastrointestinal Disorders Abdominal pain lower	1 Incidence
Incidence of Adverse Events (AEs) - Gastrointestinal Disorders Intestinal Obstruction	1 Incidence

SECONDARY outcome

Timeframe: From the first infusion of medication to 30 days after the last one

Population: All patients who received at least one dose of investigational product were included in the safety dataset.

The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.

Outcome measures

Measure	hu3S193 n=29 Participants hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Incidence of Adverse Events (AEs) - General Disorders and Administration Site Conditions Influenza like illness	8 Incidence
Incidence of Adverse Events (AEs) - General Disorders and Administration Site Conditions Fatigue	3 Incidence
Incidence of Adverse Events (AEs) - General Disorders and Administration Site Conditions Pain	2 Incidence
Incidence of Adverse Events (AEs) - General Disorders and Administration Site Conditions Pyrexia	1 Incidence

SECONDARY outcome

Timeframe: From the first infusion of medication to 30 days after the last one

Population: All patients who received at least one dose of investigational product were included in the safety dataset.

The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.

Outcome measures

Measure	hu3S193 n=29 Participants hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Incidence of Adverse Events (AEs) - Musculoskeletal and Connective Tissue Disorders Myalgia	4 Incidence
Incidence of Adverse Events (AEs) - Musculoskeletal and Connective Tissue Disorders Back pain	3 Incidence
Incidence of Adverse Events (AEs) - Musculoskeletal and Connective Tissue Disorders Pain in extremity	2 Incidence
Incidence of Adverse Events (AEs) - Musculoskeletal and Connective Tissue Disorders Arthralgia	1 Incidence
Incidence of Adverse Events (AEs) - Musculoskeletal and Connective Tissue Disorders Groin pain	1 Incidence
Incidence of Adverse Events (AEs) - Musculoskeletal and Connective Tissue Disorders Knee pain	1 Incidence
Incidence of Adverse Events (AEs) - Musculoskeletal and Connective Tissue Disorders Muscle tightness	1 Incidence
Incidence of Adverse Events (AEs) - Musculoskeletal and Connective Tissue Disorders Musculoskeletal pain	10 Incidence

SECONDARY outcome

Timeframe: From the first infusion of medication to 30 days after the last one

Population: All patients who received at least one dose of investigational product were included in the safety dataset.

The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.

Outcome measures

Measure	hu3S193 n=29 Participants hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Incidence of Adverse Events (AEs) - Immune System Disorders Hypersensitivity	9 Incidence
Incidence of Adverse Events (AEs) - Immune System Disorders Drug Hypersensitivity	2 Incidence

SECONDARY outcome

Timeframe: From the first infusion of medication to 30 days after the last one

Population: All patients who received at least one dose of investigational product were included in the safety dataset.

The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.

Outcome measures

Measure	hu3S193 n=29 Participants hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Incidence of Adverse Events (AEs) - Nervous System Disorders Headache	9 Incidence
Incidence of Adverse Events (AEs) - Nervous System Disorders Paraesthesia	1 Incidence
Incidence of Adverse Events (AEs) - Nervous System Disorders Peripheral sensory neuropathy	1 Incidence
Incidence of Adverse Events (AEs) - Nervous System Disorders Tremor	1 Incidence

SECONDARY outcome

Timeframe: From the first infusion of medication to 30 days after the last one

Population: All patients who received at least one dose of investigational product were included in the safety dataset.

The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.

Outcome measures

Measure	hu3S193 n=29 Participants hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Incidence of Adverse Events (AEs) - Investigations Neutrophil count decreased	5 Incidence
Incidence of Adverse Events (AEs) - Investigations White blood cell count decreased	3 Incidence

SECONDARY outcome

Timeframe: From the first infusion of medication to 30 days after the last one

Population: All patients who received at least one dose of investigational product were included in the safety dataset.

The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.

Outcome measures

Measure	hu3S193 n=29 Participants hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Incidence of Adverse Events (AEs) - Respiratory, Thoracic and Mediastinal Disorders Cough	6 Incidence
Incidence of Adverse Events (AEs) - Respiratory, Thoracic and Mediastinal Disorders Productive Cough	1 Incidence

SECONDARY outcome

Timeframe: From the first infusion of medication to 30 days after the last one

Population: All patients who received at least one dose of investigational product were included in the safety dataset.

The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.

Outcome measures

Measure	hu3S193 n=29 Participants hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Incidence of Adverse Events (AEs) - Infections and Infestations; Gastrointestinal Disorders Oral Herpes	2 Incidence
Incidence of Adverse Events (AEs) - Infections and Infestations; Gastrointestinal Disorders Clostridium difficile colitis	1 Incidence
Incidence of Adverse Events (AEs) - Infections and Infestations; Gastrointestinal Disorders Gastroenteritis	1 Incidence
Incidence of Adverse Events (AEs) - Infections and Infestations; Gastrointestinal Disorders Tooth abscess	1 Incidence

SECONDARY outcome

Timeframe: From the first infusion of medication to 30 days after the last one

Population: All patients who received at least one dose of investigational product were included in the safety dataset.

The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.

Outcome measures

Measure	hu3S193 n=29 Participants hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Incidence of Adverse Events (AEs) - Blood and Lymphatic System Disorders (Anaemia)	4 Incidence

SECONDARY outcome

Timeframe: From the first infusion of medication to 30 days after the last one

Population: All patients who received at least one dose of investigational product were included in the safety dataset.

The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.

Outcome measures

Measure	hu3S193 n=29 Participants hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Incidence of Adverse Events (AEs) - Infections and Infestations; Respiratory, Thoracic and Mediastinal Disorders Sinusitis	2 Incidence
Incidence of Adverse Events (AEs) - Infections and Infestations; Respiratory, Thoracic and Mediastinal Disorders Respiratory tract infection	1 Incidence
Incidence of Adverse Events (AEs) - Infections and Infestations; Respiratory, Thoracic and Mediastinal Disorders Tonsillitis	1 Incidence

SECONDARY outcome

Timeframe: From the first infusion of medication to 30 days after the last one

Population: All patients who received at least one dose of investigational product were included in the safety dataset.

The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.

Outcome measures

Measure	hu3S193 n=29 Participants hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Incidence of Adverse Events (AEs) - Psychiatric Disorders (Anxiety)	4 Incidence

SECONDARY outcome

Timeframe: From the first infusion of medication to 30 days after the last one

Population: All patients who received at least one dose of investigational product were included in the safety dataset.

The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.

Outcome measures

Measure	hu3S193 n=29 Participants hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Incidence of Adverse Events (AEs) - Vascular Disorders Hypertension	2 Incidence
Incidence of Adverse Events (AEs) - Vascular Disorders Hyperaemia	1 Incidence
Incidence of Adverse Events (AEs) - Vascular Disorders Hypotension	1 Incidence

SECONDARY outcome

Timeframe: From the first infusion of medication to 30 days after the last one

Population: All patients who received at least one dose of investigational product were included in the safety dataset.

The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.

Outcome measures

Measure	hu3S193 n=29 Participants hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Incidence of Adverse Events (AEs) - Cardiac Disorders; General Disorders and Administration Site Conditions; Respiratory, Thoracic and Mediastinal Disorders (Chest Pain)	3 Incidence

SECONDARY outcome

Timeframe: From the first infusion of medication to 30 days after the last one

Population: All patients who received at least one dose of investigational product were included in the safety dataset.

The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.

Outcome measures

Measure	hu3S193 n=29 Participants hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Incidence of Adverse Events (AEs) - General Disorders and Administration Site Conditions; Musculoskeletal and Connective Tissue Disorders (Chills)	3 Incidence

SECONDARY outcome

Timeframe: From the first infusion of medication to 30 days after the last one

Population: All patients who received at least one dose of investigational product were included in the safety dataset.

The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.

Outcome measures

Measure	hu3S193 n=29 Participants hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Incidence of Adverse Events (AEs) - Skin and Subcutaneous Tissue Disorders Erythema	2 Incidence
Incidence of Adverse Events (AEs) - Skin and Subcutaneous Tissue Disorders Pruritus	2 Incidence

SECONDARY outcome

Timeframe: From the first infusion of medication to 30 days after the last one

Population: All patients who received at least one dose of investigational product were included in the safety dataset.

The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.

Outcome measures

Measure	hu3S193 n=29 Participants hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Incidence of Adverse Events (AEs) - Ear and Labyrinth Disorders Cerumen impaction	1 Incidence
Incidence of Adverse Events (AEs) - Ear and Labyrinth Disorders Ear pain	1 Incidence

SECONDARY outcome

Timeframe: From the first infusion of medication to 30 days after the last one

Population: All patients who received at least one dose of investigational product were included in the safety dataset.

The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.

Outcome measures

Measure	hu3S193 n=29 Participants hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Incidence of Adverse Events (AEs) - Hepatobiliary Disorders; Injury, Poisoning and Procedural Complications (Hepatotoxicity)	2 Incidence

SECONDARY outcome

Timeframe: From the first infusion of medication to 30 days after the last one

Population: All patients who received at least one dose of investigational product were included in the safety dataset.

The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.

Outcome measures

Measure	hu3S193 n=29 Participants hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Incidence of Adverse Events (AEs) - Immune System Disorders; General Disorders and Administration Site Conditions; Injury, Poisoning and Procedural Complications (Infusion Related Reaction)	2 Incidence

SECONDARY outcome

Timeframe: From the first infusion of medication to 30 days after the last one

Population: All patients who received at least one dose of investigational product were included in the safety dataset.

The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.

Outcome measures

Measure	hu3S193 n=29 Participants hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Incidence of Adverse Events (AEs) - Immune System Disorders; Respiratory, Thoracic and Mediastinal Disorders Bronchospasm	1 Incidence
Incidence of Adverse Events (AEs) - Immune System Disorders; Respiratory, Thoracic and Mediastinal Disorders Rhinitis allergic	1 Incidence

SECONDARY outcome

Timeframe: From the first infusion of medication to 30 days after the last one

Population: All patients who received at least one dose of investigational product were included in the safety dataset.

The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.

Outcome measures

Measure	hu3S193 n=29 Participants hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Incidence of Adverse Events (AEs) - Musculoskeletal and Connective Tissue Disorders; General Disorders and Administration Site Conditions; Nervous System Disorders (Spinal Pain)	2 Incidence

SECONDARY outcome

Timeframe: From the first infusion of medication to 30 days after the last one

Population: All patients who received at least one dose of investigational product were included in the safety dataset.

The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.

Outcome measures

Measure	hu3S193 n=29 Participants hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Incidence of Adverse Events (AEs) - Musculoskeletal and Connective Tissue Disorders; Injury, Poisoning and Procedural Complications Hip fracture	1 Incidence
Incidence of Adverse Events (AEs) - Musculoskeletal and Connective Tissue Disorders; Injury, Poisoning and Procedural Complications Upper limb fracture	1 Incidence

SECONDARY outcome

Timeframe: From the first infusion of medication to 30 days after the last one

Population: All patients who received at least one dose of investigational product were included in the safety dataset.

The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.

Outcome measures

Measure	hu3S193 n=29 Participants hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Incidence of Adverse Events (AEs) - Psychiatric Disorders (Depression)	2 Incidence

SECONDARY outcome

Timeframe: From the first infusion of medication to 30 days after the last one

Population: All patients who received at least one dose of investigational product were included in the safety dataset.

The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.

Outcome measures

Measure	hu3S193 n=29 Participants hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Incidence of Adverse Events (AEs) - Renal and Urinary Disorders (Dysuria)	2 Incidence

SECONDARY outcome

Timeframe: From the first infusion of medication to 30 days after the last one

Population: All patients who received at least one dose of investigational product were included in the safety dataset.

The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.

Outcome measures

Measure	hu3S193 n=29 Participants hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Incidence of Adverse Events (AEs) - Renal and Urinary Disorders; Infections and Infestations (Urinary Tract Infection)	2 Incidence

SECONDARY outcome

Timeframe: From the first infusion of medication to 30 days after the last one

Population: All patients who received at least one dose of investigational product were included in the safety dataset.

The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.

Outcome measures

Measure	hu3S193 n=29 Participants hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Incidence of Adverse Events (AEs) - Reproductive System and Breast Disorders (Vulvovaginal Dryness)	2 Incidence

SECONDARY outcome

Timeframe: From the first infusion of medication to 30 days after the last one

Population: All patients who received at least one dose of investigational product were included in the safety dataset.

The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.

Outcome measures

Measure	hu3S193 n=29 Participants hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Incidence of Adverse Events (AEs) - Respiratory, Thoracic and Mediastinal Disorders; Cardiac Disorders (Dyspnoea)	2 Incidence

SECONDARY outcome

Timeframe: From the first infusion of medication to 30 days after the last one

Population: All patients who received at least one dose of investigational product were included in the safety dataset.

The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.

Outcome measures

Measure	hu3S193 n=29 Participants hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Incidence of Adverse Events (AEs) - Skin and Subcutaneous Tissue Disorders; Injury, Poisoning and Procedural Complications Excoriation	1 Incidence
Incidence of Adverse Events (AEs) - Skin and Subcutaneous Tissue Disorders; Injury, Poisoning and Procedural Complications Injection site erythema	1 Incidence

SECONDARY outcome

Timeframe: From the first infusion of medication to 30 days after the last one

Population: All patients who received at least one dose of investigational product were included in the safety dataset.

The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.

Outcome measures

Measure	hu3S193 n=29 Participants hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Incidence of Adverse Events (AEs) - Cardiac Disorders; Vascular Disorders; Nervous System Disorders (Dizziness)	1 Incidence

SECONDARY outcome

Timeframe: From the first infusion of medication to 30 days after the last one

Population: All patients who received at least one dose of investigational product were included in the safety dataset.

The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.

Outcome measures

Measure	hu3S193 n=29 Participants hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Incidence of Adverse Events (AEs) - Ear and Labyrinth Disorders; Nervous System Disorders (Vertigo)	1 Incidence

SECONDARY outcome

Timeframe: From the first infusion of medication to 30 days after the last one

Population: All patients who received at least one dose of investigational product were included in the safety dataset.

The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.

Outcome measures

Measure	hu3S193 n=29 Participants hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Incidence of Adverse Events (AEs) - Endocrine Disorders; Metabolism and Nutrition Disorders (Hyperglycaemia)	1 Incidence

SECONDARY outcome

Timeframe: From the first infusion of medication to 30 days after the last one

Population: All patients who received at least one dose of investigational product were included in the safety dataset.

The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.

Outcome measures

Measure	hu3S193 n=29 Participants hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Incidence of Adverse Events (AEs) - Eye Disorders (Ocular Hyperaemia)	1 Incidence

SECONDARY outcome

Timeframe: From the first infusion of medication to 30 days after the last one

Population: All patients who received at least one dose of investigational product were included in the safety dataset.

The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.

Outcome measures

Measure	hu3S193 n=29 Participants hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Incidence of Adverse Events (AEs) - Gastrointestinal Disorders; Infections and Infestations; Respiratory, Thoracic and Mediastinal Disorders (Pharyngitis)	1 Incidence

SECONDARY outcome

Timeframe: From the first infusion of medication to 30 days after the last one

Population: All patients who received at least one dose of investigational product were included in the safety dataset.

The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.

Outcome measures

Measure	hu3S193 n=29 Participants hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Incidence of Adverse Events (AEs) - Gastrointestinal Disorders; Reproductive System and Breast Disorders; Renal and Urinary Disorders (Pelvic Pain)	1 Incidence

SECONDARY outcome

Timeframe: From the first infusion of medication to 30 days after the last one

Population: All patients who received at least one dose of investigational product were included in the safety dataset.

The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.

Outcome measures

Measure	hu3S193 n=29 Participants hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Incidence of Adverse Events (AEs) - Gastrointestinal Disorders; Vascular Disorders (Anal Haemorrhage)	1 Incidence

SECONDARY outcome

Timeframe: From the first infusion of medication to 30 days after the last one

Population: All patients who received at least one dose of investigational product were included in the safety dataset.

The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.

Outcome measures

Measure	hu3S193 n=29 Participants hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Incidence of Adverse Events (AEs) - General Disorders and Administration Site Conditions; Injury, Poisoning and Procedural Complications (Hyperthermia)	1 Incidence

SECONDARY outcome

Timeframe: From the first infusion of medication to 30 days after the last one

Population: All patients who received at least one dose of investigational product were included in the safety dataset.

The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.

Outcome measures

Measure	hu3S193 n=29 Participants hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Incidence of Adverse Events (AEs) - General Disorders and Administration Site Conditions; Injury, Poisoning and Procedural Complications (Catheter Site Inflammation)	1 Incidence

SECONDARY outcome

Timeframe: From the first infusion of medication to 30 days after the last one

Population: All patients who received at least one dose of investigational product were included in the safety dataset.

The incidence of adverse events (percentage of patients with at least one adverse event and serious adverse events (overall and with reasonable relationship)) was assessed for the safety population

Outcome measures

Measure	hu3S193 n=29 Participants hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Incidence of Adverse Events (AEs) - Immune System Disorders; Blood and Lymphatic System Disorders; Injury, Poisoning and Procedural Complications (Transfusion Reaction)	1 Incidence

SECONDARY outcome

Timeframe: From the first infusion of medication to 30 days after the last one

Population: All patients who received at least one dose of investigational product were included in the safety dataset.

The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.

Outcome measures

Measure	hu3S193 n=29 Participants hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Incidence of Adverse Events (AEs) - Infections and Infestations; Respiratory, Thoracic and Mediastinal Disorders (Bronchitis)	1 Incidence

SECONDARY outcome

Timeframe: From the first infusion of medication to 30 days after the last one

Population: All patients who received at least one dose of investigational product were included in the safety dataset.

The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.

Outcome measures

Measure	hu3S193 n=29 Participants hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Incidence of Adverse Events (AEs) - Infections and Infestations; Renal and Urinary Disorders (Urinary Tract Infection Bacterial)	1 Incidence

SECONDARY outcome

Timeframe: From the first infusion of medication to 30 days after the last one

Population: All patients who received at least one dose of investigational product were included in the safety dataset.

The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.

Outcome measures

Measure	hu3S193 n=29 Participants hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Incidence of Adverse Events (AEs) - Investigations (Blood Cholesterol Increased)	1 Incidence

SECONDARY outcome

Timeframe: From the first infusion of medication to 30 days after the last one

Population: All patients who received at least one dose of investigational product were included in the safety dataset.

The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.

Outcome measures

Measure	hu3S193 n=29 Participants hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Incidence of Adverse Events (AEs) - Musculoskeletal and Connective Tissue Disorders; General Disorders and Administration Site Conditions; Renal and Urinary Disorders (Flank Pain)	1 Incidence

SECONDARY outcome

Timeframe: From the first infusion of medication to 30 days after the last one

Population: All patients who received at least one dose of investigational product were included in the safety dataset.

The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.

Outcome measures

Measure	hu3S193 n=29 Participants hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Incidence of Adverse Events (AEs) - Nervous System Disorders; Psychiatric Disorders; Respiratory, Thoracic and Mediastinal Disorders (Hoarseness)	1 Incidence

SECONDARY outcome

Timeframe: From the first infusion of medication to 30 days after the last one

Population: All patients who received at least one dose of investigational product were included in the safety dataset.

The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.

Outcome measures

Measure	hu3S193 n=29 Participants hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Incidence of Adverse Events (AEs) - Psychiatric Disorders; Nervous System Disorders (Insomnia)	1 Incidence

SECONDARY outcome

Timeframe: From the first infusion of medication to 30 days after the last one

Population: All patients who received at least one dose of investigational product were included in the safety dataset.

The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.

Outcome measures

Measure	hu3S193 n=29 Participants hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Incidence of Adverse Events (AEs) - Skin and Subcutaneous Tissue Disorders; Infections and Infestations (Tinea Pedis)	1 Incidence

SECONDARY outcome

Timeframe: From the first infusion of medication to 30 days after the last one

Population: All patients who received at least one dose of investigational product were included in the safety dataset.

The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.

Outcome measures

Measure	hu3S193 n=29 Participants hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Incidence of Adverse Events (AEs) - Skin and Subcutaneous Tissue Disorders; Reproductive System and Breast Disorders (Vulvovaginal Pruritus)	1 Incidence

SECONDARY outcome

Timeframe: From the first infusion of medication to 30 days after the last one

Population: All patients who received at least one dose of investigational product were included in the safety dataset.

The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.

Outcome measures

Measure	hu3S193 n=29 Participants hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Incidence of Adverse Events (AEs) - Vascular Disorders; Gastrointestinal Disorders (Haemorrhoids)	1 Incidence

SECONDARY outcome

Timeframe: From the first infusion of medication to 30 days after the last one

Population: All patients who received at least one dose of investigational product were included in the safety dataset.

The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.

Outcome measures

Measure	hu3S193 n=29 Participants hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Incidence of Adverse Events (AEs) - Vascular Disorders; Respiratory, Thoracic and Mediastinal Disorders (Epistaxis)	1 Incidence

SECONDARY outcome

Timeframe: From the first infusion of medication to 30 days after the last one

Population: All patients who received at least one dose of investigational product were included in the safety dataset.

A SAE was defined as an AE that met one of the following conditions: Death during the protocol-defined surveillance period; Potentially fatal event (defined as a patient at immediate risk of death at the time of the event); An event requiring the patient's hospitalization or prolongation of an existing hospitalization during the protocol-defined surveillance period; An event resulting in congenital anomaly or birth defect; An event resulting in a persistent or significant disability/incapacity; Any other major medical event that did not result in death, was not life threatening, or did not require hospitalization, but that could be considered a SAE when, based on the appropriate medical judgment, it presented a risk for the patient and required medical or surgical intervention to prevent one of the outcomes listed above.

Outcome measures

Measure	hu3S193 n=29 Participants hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Incidence of Serious Adverse Events (SAEs) - Gastrointestinal Disorders Intestinal obstruction	1 Incidence
Incidence of Serious Adverse Events (SAEs) - Gastrointestinal Disorders Vomiting	1 Incidence

SECONDARY outcome

Timeframe: From the first infusion of medication to 30 days after the last one

Population: All patients who received at least one dose of investigational product were included in the safety dataset.

A SAE was defined as an AE that met one of the following conditions: Death during the protocol-defined surveillance period; Potentially fatal event (defined as a patient at immediate risk of death at the time of the event); An event requiring the patient's hospitalization or prolongation of an existing hospitalization during the protocol-defined surveillance period; An event resulting in congenital anomaly or birth defect; An event resulting in a persistent or significant disability/incapacity; Any other major medical event that did not result in death, was not life threatening, or did not require hospitalization, but that could be considered a SAE when, based on the appropriate medical judgment, it presented a risk for the patient and required medical or surgical intervention to prevent one of the outcomes listed above.

Outcome measures

Measure	hu3S193 n=29 Participants hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Incidence of Serious Adverse Events (SAEs) - Musculoskeletal and Connective Tissue Disorders - Hip Fracture	1 Incidence

SECONDARY outcome

Timeframe: Predose and Postdose on weeks 1, 2, 3, 4, 5, 7 and 9

Population: PK samples were analyzed from 10 patients. Dose: 30 mg/m2 every two weeks

Cmax = Peak (postdosing) Hu3S193 plasma concentration. Cmin = Trough (predosing) Hu3S193 plasma concentration (Cmin). Plasma concentration of Hu3S193 expressed in μg/mL.

Outcome measures

Measure	hu3S193 n=10 Participants hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Overall Mean Pharmacokinetic (PK) Data (Minimum and Maximum Concentrations) Cmin	2.14 (µg/mL) Standard Deviation 0.92
Overall Mean Pharmacokinetic (PK) Data (Minimum and Maximum Concentrations) Cmax	18.32 (µg/mL) Standard Deviation 5.66

SECONDARY outcome

Timeframe: 2-year overall survival rate after the beginning of rescue platinum-based chemotherapy.

Population: Within the ITT population, 7 patients died and 22 were censored. The median time to death was 25.1 months (95% CI, 16.7 to 32.4 months).

Overall survival was calculated as the time interval between the date of beginning of rescue platinum-based chemotherapy and date of death for any cause.

Outcome measures

Measure	hu3S193 n=29 Participants hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Two-year Overall Survival: Median Time to Death	25.1 months Interval 16.7 to 32.4

Adverse Events

hu3S193

Serious events: 3 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Measure	hu3S193 n=29 participants at risk hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Gastrointestinal disorders Intestinal obstruction	3.4% 1/29 • Number of events 1 • They were collected from first application of treatment to 30 days after last. Ongoing AEs were followed up until resolution, start of a new treatment, at the investigator discretion or if they became chronic. After the 30-day period, the investigator reported the adverse events that in his/her opinion were related to investigational product. In this study, AEs terms were coded using the Medical Dictionary for Regulatory Activities (MedDRA) at the Preferred Term (PT) and System Organ Class (SOC) levels.
Gastrointestinal disorders Vomiting	3.4% 1/29 • Number of events 1 • They were collected from first application of treatment to 30 days after last. Ongoing AEs were followed up until resolution, start of a new treatment, at the investigator discretion or if they became chronic. After the 30-day period, the investigator reported the adverse events that in his/her opinion were related to investigational product. In this study, AEs terms were coded using the Medical Dictionary for Regulatory Activities (MedDRA) at the Preferred Term (PT) and System Organ Class (SOC) levels.
Musculoskeletal and connective tissue disorders Hip fracture	3.4% 1/29 • Number of events 1 • They were collected from first application of treatment to 30 days after last. Ongoing AEs were followed up until resolution, start of a new treatment, at the investigator discretion or if they became chronic. After the 30-day period, the investigator reported the adverse events that in his/her opinion were related to investigational product. In this study, AEs terms were coded using the Medical Dictionary for Regulatory Activities (MedDRA) at the Preferred Term (PT) and System Organ Class (SOC) levels.

Other adverse events

Measure	hu3S193 n=29 participants at risk hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Gastrointestinal disorders Nausea	65.5% 19/29 • Number of events 69 • They were collected from first application of treatment to 30 days after last. Ongoing AEs were followed up until resolution, start of a new treatment, at the investigator discretion or if they became chronic. After the 30-day period, the investigator reported the adverse events that in his/her opinion were related to investigational product. In this study, AEs terms were coded using the Medical Dictionary for Regulatory Activities (MedDRA) at the Preferred Term (PT) and System Organ Class (SOC) levels.
Gastrointestinal disorders Vomiting	58.6% 17/29 • Number of events 64 • They were collected from first application of treatment to 30 days after last. Ongoing AEs were followed up until resolution, start of a new treatment, at the investigator discretion or if they became chronic. After the 30-day period, the investigator reported the adverse events that in his/her opinion were related to investigational product. In this study, AEs terms were coded using the Medical Dictionary for Regulatory Activities (MedDRA) at the Preferred Term (PT) and System Organ Class (SOC) levels.
Gastrointestinal disorders Abdominal pain	31.0% 9/29 • Number of events 16 • They were collected from first application of treatment to 30 days after last. Ongoing AEs were followed up until resolution, start of a new treatment, at the investigator discretion or if they became chronic. After the 30-day period, the investigator reported the adverse events that in his/her opinion were related to investigational product. In this study, AEs terms were coded using the Medical Dictionary for Regulatory Activities (MedDRA) at the Preferred Term (PT) and System Organ Class (SOC) levels.
Gastrointestinal disorders Constipation	24.1% 7/29 • Number of events 10 • They were collected from first application of treatment to 30 days after last. Ongoing AEs were followed up until resolution, start of a new treatment, at the investigator discretion or if they became chronic. After the 30-day period, the investigator reported the adverse events that in his/her opinion were related to investigational product. In this study, AEs terms were coded using the Medical Dictionary for Regulatory Activities (MedDRA) at the Preferred Term (PT) and System Organ Class (SOC) levels.
Gastrointestinal disorders Diarrhoea	20.7% 6/29 • Number of events 8 • They were collected from first application of treatment to 30 days after last. Ongoing AEs were followed up until resolution, start of a new treatment, at the investigator discretion or if they became chronic. After the 30-day period, the investigator reported the adverse events that in his/her opinion were related to investigational product. In this study, AEs terms were coded using the Medical Dictionary for Regulatory Activities (MedDRA) at the Preferred Term (PT) and System Organ Class (SOC) levels.
Gastrointestinal disorders Abdominal pain upper	10.3% 3/29 • Number of events 3 • They were collected from first application of treatment to 30 days after last. Ongoing AEs were followed up until resolution, start of a new treatment, at the investigator discretion or if they became chronic. After the 30-day period, the investigator reported the adverse events that in his/her opinion were related to investigational product. In this study, AEs terms were coded using the Medical Dictionary for Regulatory Activities (MedDRA) at the Preferred Term (PT) and System Organ Class (SOC) levels.
Gastrointestinal disorders Dry mouth	6.9% 2/29 • Number of events 2 • They were collected from first application of treatment to 30 days after last. Ongoing AEs were followed up until resolution, start of a new treatment, at the investigator discretion or if they became chronic. After the 30-day period, the investigator reported the adverse events that in his/her opinion were related to investigational product. In this study, AEs terms were coded using the Medical Dictionary for Regulatory Activities (MedDRA) at the Preferred Term (PT) and System Organ Class (SOC) levels.
Gastrointestinal disorders Dyspepsia	6.9% 2/29 • Number of events 2 • They were collected from first application of treatment to 30 days after last. Ongoing AEs were followed up until resolution, start of a new treatment, at the investigator discretion or if they became chronic. After the 30-day period, the investigator reported the adverse events that in his/her opinion were related to investigational product. In this study, AEs terms were coded using the Medical Dictionary for Regulatory Activities (MedDRA) at the Preferred Term (PT) and System Organ Class (SOC) levels.
General disorders Influenza like illness	27.6% 8/29 • Number of events 9 • They were collected from first application of treatment to 30 days after last. Ongoing AEs were followed up until resolution, start of a new treatment, at the investigator discretion or if they became chronic. After the 30-day period, the investigator reported the adverse events that in his/her opinion were related to investigational product. In this study, AEs terms were coded using the Medical Dictionary for Regulatory Activities (MedDRA) at the Preferred Term (PT) and System Organ Class (SOC) levels.
General disorders Fatigue	10.3% 3/29 • Number of events 4 • They were collected from first application of treatment to 30 days after last. Ongoing AEs were followed up until resolution, start of a new treatment, at the investigator discretion or if they became chronic. After the 30-day period, the investigator reported the adverse events that in his/her opinion were related to investigational product. In this study, AEs terms were coded using the Medical Dictionary for Regulatory Activities (MedDRA) at the Preferred Term (PT) and System Organ Class (SOC) levels.
General disorders Pain	6.9% 2/29 • Number of events 2 • They were collected from first application of treatment to 30 days after last. Ongoing AEs were followed up until resolution, start of a new treatment, at the investigator discretion or if they became chronic. After the 30-day period, the investigator reported the adverse events that in his/her opinion were related to investigational product. In this study, AEs terms were coded using the Medical Dictionary for Regulatory Activities (MedDRA) at the Preferred Term (PT) and System Organ Class (SOC) levels.
Musculoskeletal and connective tissue disorders Myalgia	13.8% 4/29 • Number of events 13 • They were collected from first application of treatment to 30 days after last. Ongoing AEs were followed up until resolution, start of a new treatment, at the investigator discretion or if they became chronic. After the 30-day period, the investigator reported the adverse events that in his/her opinion were related to investigational product. In this study, AEs terms were coded using the Medical Dictionary for Regulatory Activities (MedDRA) at the Preferred Term (PT) and System Organ Class (SOC) levels.
Musculoskeletal and connective tissue disorders Back pain	10.3% 3/29 • Number of events 4 • They were collected from first application of treatment to 30 days after last. Ongoing AEs were followed up until resolution, start of a new treatment, at the investigator discretion or if they became chronic. After the 30-day period, the investigator reported the adverse events that in his/her opinion were related to investigational product. In this study, AEs terms were coded using the Medical Dictionary for Regulatory Activities (MedDRA) at the Preferred Term (PT) and System Organ Class (SOC) levels.
Musculoskeletal and connective tissue disorders Pain in extremity	6.9% 2/29 • Number of events 5 • They were collected from first application of treatment to 30 days after last. Ongoing AEs were followed up until resolution, start of a new treatment, at the investigator discretion or if they became chronic. After the 30-day period, the investigator reported the adverse events that in his/her opinion were related to investigational product. In this study, AEs terms were coded using the Medical Dictionary for Regulatory Activities (MedDRA) at the Preferred Term (PT) and System Organ Class (SOC) levels.
Immune system disorders Hypersensitivity	31.0% 9/29 • Number of events 9 • They were collected from first application of treatment to 30 days after last. Ongoing AEs were followed up until resolution, start of a new treatment, at the investigator discretion or if they became chronic. After the 30-day period, the investigator reported the adverse events that in his/her opinion were related to investigational product. In this study, AEs terms were coded using the Medical Dictionary for Regulatory Activities (MedDRA) at the Preferred Term (PT) and System Organ Class (SOC) levels.
Immune system disorders Drug hypersensitivity	6.9% 2/29 • Number of events 2 • They were collected from first application of treatment to 30 days after last. Ongoing AEs were followed up until resolution, start of a new treatment, at the investigator discretion or if they became chronic. After the 30-day period, the investigator reported the adverse events that in his/her opinion were related to investigational product. In this study, AEs terms were coded using the Medical Dictionary for Regulatory Activities (MedDRA) at the Preferred Term (PT) and System Organ Class (SOC) levels.
Nervous system disorders Headache	31.0% 9/29 • Number of events 26 • They were collected from first application of treatment to 30 days after last. Ongoing AEs were followed up until resolution, start of a new treatment, at the investigator discretion or if they became chronic. After the 30-day period, the investigator reported the adverse events that in his/her opinion were related to investigational product. In this study, AEs terms were coded using the Medical Dictionary for Regulatory Activities (MedDRA) at the Preferred Term (PT) and System Organ Class (SOC) levels.
Investigations Neutrophil count decreased	17.2% 5/29 • Number of events 6 • They were collected from first application of treatment to 30 days after last. Ongoing AEs were followed up until resolution, start of a new treatment, at the investigator discretion or if they became chronic. After the 30-day period, the investigator reported the adverse events that in his/her opinion were related to investigational product. In this study, AEs terms were coded using the Medical Dictionary for Regulatory Activities (MedDRA) at the Preferred Term (PT) and System Organ Class (SOC) levels.
Investigations White blood cell count decreased	10.3% 3/29 • Number of events 3 • They were collected from first application of treatment to 30 days after last. Ongoing AEs were followed up until resolution, start of a new treatment, at the investigator discretion or if they became chronic. After the 30-day period, the investigator reported the adverse events that in his/her opinion were related to investigational product. In this study, AEs terms were coded using the Medical Dictionary for Regulatory Activities (MedDRA) at the Preferred Term (PT) and System Organ Class (SOC) levels.
Respiratory, thoracic and mediastinal disorders Cough	20.7% 6/29 • Number of events 14 • They were collected from first application of treatment to 30 days after last. Ongoing AEs were followed up until resolution, start of a new treatment, at the investigator discretion or if they became chronic. After the 30-day period, the investigator reported the adverse events that in his/her opinion were related to investigational product. In this study, AEs terms were coded using the Medical Dictionary for Regulatory Activities (MedDRA) at the Preferred Term (PT) and System Organ Class (SOC) levels.
Infections and infestations Oral herpes	6.9% 2/29 • Number of events 2 • They were collected from first application of treatment to 30 days after last. Ongoing AEs were followed up until resolution, start of a new treatment, at the investigator discretion or if they became chronic. After the 30-day period, the investigator reported the adverse events that in his/her opinion were related to investigational product. In this study, AEs terms were coded using the Medical Dictionary for Regulatory Activities (MedDRA) at the Preferred Term (PT) and System Organ Class (SOC) levels.
Blood and lymphatic system disorders Anaemia	13.8% 4/29 • Number of events 4 • They were collected from first application of treatment to 30 days after last. Ongoing AEs were followed up until resolution, start of a new treatment, at the investigator discretion or if they became chronic. After the 30-day period, the investigator reported the adverse events that in his/her opinion were related to investigational product. In this study, AEs terms were coded using the Medical Dictionary for Regulatory Activities (MedDRA) at the Preferred Term (PT) and System Organ Class (SOC) levels.
Infections and infestations Sinusitis	6.9% 2/29 • Number of events 3 • They were collected from first application of treatment to 30 days after last. Ongoing AEs were followed up until resolution, start of a new treatment, at the investigator discretion or if they became chronic. After the 30-day period, the investigator reported the adverse events that in his/her opinion were related to investigational product. In this study, AEs terms were coded using the Medical Dictionary for Regulatory Activities (MedDRA) at the Preferred Term (PT) and System Organ Class (SOC) levels.
Psychiatric disorders Anxiety	13.8% 4/29 • Number of events 8 • They were collected from first application of treatment to 30 days after last. Ongoing AEs were followed up until resolution, start of a new treatment, at the investigator discretion or if they became chronic. After the 30-day period, the investigator reported the adverse events that in his/her opinion were related to investigational product. In this study, AEs terms were coded using the Medical Dictionary for Regulatory Activities (MedDRA) at the Preferred Term (PT) and System Organ Class (SOC) levels.
Vascular disorders Hypertension	6.9% 2/29 • Number of events 2 • They were collected from first application of treatment to 30 days after last. Ongoing AEs were followed up until resolution, start of a new treatment, at the investigator discretion or if they became chronic. After the 30-day period, the investigator reported the adverse events that in his/her opinion were related to investigational product. In this study, AEs terms were coded using the Medical Dictionary for Regulatory Activities (MedDRA) at the Preferred Term (PT) and System Organ Class (SOC) levels.
Cardiac disorders Chest pain	10.3% 3/29 • Number of events 4 • They were collected from first application of treatment to 30 days after last. Ongoing AEs were followed up until resolution, start of a new treatment, at the investigator discretion or if they became chronic. After the 30-day period, the investigator reported the adverse events that in his/her opinion were related to investigational product. In this study, AEs terms were coded using the Medical Dictionary for Regulatory Activities (MedDRA) at the Preferred Term (PT) and System Organ Class (SOC) levels.
General disorders Chills	10.3% 3/29 • Number of events 3 • They were collected from first application of treatment to 30 days after last. Ongoing AEs were followed up until resolution, start of a new treatment, at the investigator discretion or if they became chronic. After the 30-day period, the investigator reported the adverse events that in his/her opinion were related to investigational product. In this study, AEs terms were coded using the Medical Dictionary for Regulatory Activities (MedDRA) at the Preferred Term (PT) and System Organ Class (SOC) levels.
Skin and subcutaneous tissue disorders Erythema	6.9% 2/29 • Number of events 3 • They were collected from first application of treatment to 30 days after last. Ongoing AEs were followed up until resolution, start of a new treatment, at the investigator discretion or if they became chronic. After the 30-day period, the investigator reported the adverse events that in his/her opinion were related to investigational product. In this study, AEs terms were coded using the Medical Dictionary for Regulatory Activities (MedDRA) at the Preferred Term (PT) and System Organ Class (SOC) levels.
Skin and subcutaneous tissue disorders Pruritus	6.9% 2/29 • Number of events 3 • They were collected from first application of treatment to 30 days after last. Ongoing AEs were followed up until resolution, start of a new treatment, at the investigator discretion or if they became chronic. After the 30-day period, the investigator reported the adverse events that in his/her opinion were related to investigational product. In this study, AEs terms were coded using the Medical Dictionary for Regulatory Activities (MedDRA) at the Preferred Term (PT) and System Organ Class (SOC) levels.
Hepatobiliary disorders Hepatotoxicity	6.9% 2/29 • Number of events 3 • They were collected from first application of treatment to 30 days after last. Ongoing AEs were followed up until resolution, start of a new treatment, at the investigator discretion or if they became chronic. After the 30-day period, the investigator reported the adverse events that in his/her opinion were related to investigational product. In this study, AEs terms were coded using the Medical Dictionary for Regulatory Activities (MedDRA) at the Preferred Term (PT) and System Organ Class (SOC) levels.
Immune system disorders Infusion related reaction	6.9% 2/29 • Number of events 2 • They were collected from first application of treatment to 30 days after last. Ongoing AEs were followed up until resolution, start of a new treatment, at the investigator discretion or if they became chronic. After the 30-day period, the investigator reported the adverse events that in his/her opinion were related to investigational product. In this study, AEs terms were coded using the Medical Dictionary for Regulatory Activities (MedDRA) at the Preferred Term (PT) and System Organ Class (SOC) levels.
Musculoskeletal and connective tissue disorders Spinal pain	6.9% 2/29 • Number of events 2 • They were collected from first application of treatment to 30 days after last. Ongoing AEs were followed up until resolution, start of a new treatment, at the investigator discretion or if they became chronic. After the 30-day period, the investigator reported the adverse events that in his/her opinion were related to investigational product. In this study, AEs terms were coded using the Medical Dictionary for Regulatory Activities (MedDRA) at the Preferred Term (PT) and System Organ Class (SOC) levels.
Psychiatric disorders Depression	6.9% 2/29 • Number of events 2 • They were collected from first application of treatment to 30 days after last. Ongoing AEs were followed up until resolution, start of a new treatment, at the investigator discretion or if they became chronic. After the 30-day period, the investigator reported the adverse events that in his/her opinion were related to investigational product. In this study, AEs terms were coded using the Medical Dictionary for Regulatory Activities (MedDRA) at the Preferred Term (PT) and System Organ Class (SOC) levels.
Renal and urinary disorders Dysuria	6.9% 2/29 • Number of events 3 • They were collected from first application of treatment to 30 days after last. Ongoing AEs were followed up until resolution, start of a new treatment, at the investigator discretion or if they became chronic. After the 30-day period, the investigator reported the adverse events that in his/her opinion were related to investigational product. In this study, AEs terms were coded using the Medical Dictionary for Regulatory Activities (MedDRA) at the Preferred Term (PT) and System Organ Class (SOC) levels.
Renal and urinary disorders Urinary tract infection	6.9% 2/29 • Number of events 2 • They were collected from first application of treatment to 30 days after last. Ongoing AEs were followed up until resolution, start of a new treatment, at the investigator discretion or if they became chronic. After the 30-day period, the investigator reported the adverse events that in his/her opinion were related to investigational product. In this study, AEs terms were coded using the Medical Dictionary for Regulatory Activities (MedDRA) at the Preferred Term (PT) and System Organ Class (SOC) levels.
Reproductive system and breast disorders Vulvovaginal dryness	6.9% 2/29 • Number of events 2 • They were collected from first application of treatment to 30 days after last. Ongoing AEs were followed up until resolution, start of a new treatment, at the investigator discretion or if they became chronic. After the 30-day period, the investigator reported the adverse events that in his/her opinion were related to investigational product. In this study, AEs terms were coded using the Medical Dictionary for Regulatory Activities (MedDRA) at the Preferred Term (PT) and System Organ Class (SOC) levels.
Respiratory, thoracic and mediastinal disorders Dyspnoea	6.9% 2/29 • Number of events 2 • They were collected from first application of treatment to 30 days after last. Ongoing AEs were followed up until resolution, start of a new treatment, at the investigator discretion or if they became chronic. After the 30-day period, the investigator reported the adverse events that in his/her opinion were related to investigational product. In this study, AEs terms were coded using the Medical Dictionary for Regulatory Activities (MedDRA) at the Preferred Term (PT) and System Organ Class (SOC) levels.

Additional Information

Director of Clinical Trials

Recepta Biopharma

Phone: 55 11 3709-2140

Email: recepta@receptabio.com.br

Results disclosure agreements

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

Restriction type: LTE60