Trial Outcomes & Findings for Hu3S193 in Treating Women With Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer (NCT NCT00617773)

Last Updated: 2013-11-26

Results Overview

Best response recorded from the start of treatment until disease progression/recurrence. Includes all patients evaluable for efficacy, regardless of used criteria: RECIST or CA-125 (Cancer Antigen 125). Evaluation of target lesions: Complete Response (CR), resolution of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter (LD sum) of target lesions, taking as reference the baseline LD sum; Progressive Disease (PD), a 20% increase in LD sum of target lesions or the appearance of new lesion(s); Stable Disease (SD), no sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD. Evaluation of non-target lesions: CR, resolution of all non-target lesions and normalization of CA-125 level; SD, persistence of one or more non-target lesions and/or maintenance of CA-125 level above the normal limits; PD, appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

31 participants

Primary outcome timeframe

From start of study treatment until the end of Cycle 1 (8 weeks), Cycle 2 (16 weeks) or Cycle 3 (24 weeks).

Results posted on

2013-11-26

Participant Flow

This was a brazilian, multicentric clinical trial. From June 20, 2008 to July 13, 2010 (recruitment period of 24 months) a total of 51 patients were screened for this study, of whom 31 were considered eligible and received at least one dose of the investigational product and 20 were considered non-eligible.

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

Participant milestones
Measure	hu3S193 hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
Overall Study STARTED	31
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	24

Reasons for withdrawal

Reasons for withdrawal
Measure	hu3S193 hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
Overall Study Physician Decision	1
Overall Study Lack of compliance with the protocol	1
Overall Study Withdrawal by Subject	1
Overall Study Death	1
Overall Study Progressive disease	19
Overall Study Protocol Violation	1

Baseline Characteristics

Hu3S193 in Treating Women With Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	hu3S193 n=31 Participants hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment Brazil	31 participants n=5 Participants
Expression of the Lewis Y antigen in tumor tissue Positive (+1)	14 participants n=5 Participants
Expression of the Lewis Y antigen in tumor tissue Positive (+2)	6 participants n=5 Participants
Expression of the Lewis Y antigen in tumor tissue Positive (+3)	8 participants n=5 Participants
Expression of the Lewis Y antigen in tumor tissue Positive (+4)	3 participants n=5 Participants
ABO blood type Type A	11 participants n=5 Participants
ABO blood type Type B	1 participants n=5 Participants
ABO blood type Type AB	2 participants n=5 Participants
ABO blood type Type O	17 participants n=5 Participants

PRIMARY outcome

Timeframe: From start of study treatment until the end of Cycle 1 (8 weeks), Cycle 2 (16 weeks) or Cycle 3 (24 weeks).

Population: All patients enrolled in the study that received at least 4 doses of investigational product were considered to the efficacy evaluation.

Outcome measures

Outcome measures
Measure	hu3S193 n=26 Participants hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
Best Overall Response Complete response	0 participants
Best Overall Response Partial response	0 participants
Best Overall Response Stable disease	13 participants
Best Overall Response Disease progression	11 participants
Best Overall Response Unknown	2 participants

SECONDARY outcome

Timeframe: From the first dose of investigational product up to 30 days after the last dose of investigational product

Population: All patients enrolled in the study that received at least 1 dose of investigational product were considered for safety evaluation.

A listing of all adverse events is located in the Reported Adverse Event module.

Outcome measures

Outcome measures
Measure	hu3S193 n=31 Participants hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
Number of Participants With Adverse Events and Serious Adverse Events Adverse Events	31 participants
Number of Participants With Adverse Events and Serious Adverse Events Serious Adverse Events	9 participants

SECONDARY outcome

Timeframe: From the first dose of investigational product up to 30 days after the last dose of investigational product

Adverse events with possible, probable or definite relationship to the investigational product were considered to be reasonably related.

Outcome measures

Outcome measures
Measure	hu3S193 n=31 Participants hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
Number of Participants With Adverse Events Reasonably Related to the Investigational Product (Incidence Greater Than 5%). Adverse event: Nausea	5 participants
Number of Participants With Adverse Events Reasonably Related to the Investigational Product (Incidence Greater Than 5%). Adverse event: Fatigue	4 participants
Number of Participants With Adverse Events Reasonably Related to the Investigational Product (Incidence Greater Than 5%). Adverse event: Diarrhoea	3 participants
Number of Participants With Adverse Events Reasonably Related to the Investigational Product (Incidence Greater Than 5%). Adverse event: Hypersensitivity	3 participants
Number of Participants With Adverse Events Reasonably Related to the Investigational Product (Incidence Greater Than 5%). Adverse event: Hypertension	3 participants
Number of Participants With Adverse Events Reasonably Related to the Investigational Product (Incidence Greater Than 5%). Adverse event: Pyrexia	3 participants
Number of Participants With Adverse Events Reasonably Related to the Investigational Product (Incidence Greater Than 5%). Adverse event: Constipation	2 participants
Number of Participants With Adverse Events Reasonably Related to the Investigational Product (Incidence Greater Than 5%). Adverse event: Dry mouth	2 participants
Number of Participants With Adverse Events Reasonably Related to the Investigational Product (Incidence Greater Than 5%). Adverse event: Haemoglobin abnormal	2 participants
Number of Participants With Adverse Events Reasonably Related to the Investigational Product (Incidence Greater Than 5%). Adverse event: Tremor	2 participants
Number of Participants With Adverse Events Reasonably Related to the Investigational Product (Incidence Greater Than 5%). Adverse event: Urticaria	2 participants

SECONDARY outcome

Timeframe: Pre-dose (within 10 minutes) and Post-dose (5 minutes after completion of infusion) on weeks 1, 2, 3, and 4 of Cycle 1.

Population: All patients enrolled in the study that received at least 4 doses of investigational product were considered to this analysis.

Cmax = Peak (post-dosing) IP (Investigational Product) plasma concentration. Cmin = Trough (pre-dosing) IP plasma concentration (Cmin). Plasma concentration of Hu3S193 expressed in µg/mL.

Outcome measures

Outcome measures
Measure	hu3S193 n=26 Participants hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
Mean Cmax and Cmin of Hu3S193 Relating to the First 4 Doses. Mean Cmax of Hu3S193	16.7 µg/mL Standard Deviation 3.7
Mean Cmax and Cmin of Hu3S193 Relating to the First 4 Doses. Mean Cmin of Hu3S193	2.1 µg/mL Standard Deviation 1

SECONDARY outcome

Timeframe: Pre-dose (within 10 minutes) and Post-dose (5 minutes after completion of infusion) on weeks 1, 2, 3, 4, 5, 6, 7 and 8 of Cycle 1.

Population: All patients enrolled in the study that received at least 8 doses of investigational product were considered to this analysis.

Cmax = Peak (post-dosing) IP plasma concentration. Cmin = Trough (pre-dosing) IP plasma concentration (Cmin). Plasma concentration of Hu3S193 expressed in µg/mL.

Outcome measures

Outcome measures
Measure	hu3S193 n=17 Participants hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
Mean Cmax and Cmin of Hu3S193 Relating to the First 8 Doses Mean Cmax of Hu3S193	10.9 µg/mL Standard Deviation 4.7
Mean Cmax and Cmin of Hu3S193 Relating to the First 8 Doses Mean Cmin of Hu3S193	2.3 µg/mL Standard Deviation 0.8

OTHER_PRE_SPECIFIED outcome

Timeframe: From start of study treatment until the end of Cycle 3 (24 weeks).

Population: All patients enrolled in the study that received at least 4 doses of investigational product and that were evaluable for response were considered to this analysis.

The clinical benefit was calculated considering all patients with objective response rate (CR + PR) or stable disease (SD) for at least 24 weeks according RECIST or CA-125 if patients were non-assessable or when assessment by RECIST was unknown. Clinical benefit = 100% x (Number of patients with objective response + Number of patients with stable disease for at least 24 weeks) / Number of patients included in the efficacy population. The evaluation of target and non-target lesions is described at the Outcome Measure titled "Best Overall Response". CR: Complete Response; PR: Partial Response; SD: Stable Disease.

Outcome measures

Outcome measures
Measure	hu3S193 n=24 Participants hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
Clinical Benefit	25.0 percentage of participants Interval 9.77 to 46.71

OTHER_PRE_SPECIFIED outcome

Timeframe: From the first day of the investigational product administration until documentation of disease progression or death due to any cause (whichever occurred first). An average of 16.5549 weeks.

Population: All patients enrolled in the study that received at least 4 doses of investigational product and that were evaluable for response were considered to this analysis.

Progression free survival (PFS) is defined as the duration of time from start of treatment to time of disease progression.

Outcome measures

Outcome measures
Measure	hu3S193 n=26 Participants hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
Progression Free Survival (PFS)	8.4286 weeks Interval 4.1429 to 87.0

OTHER_PRE_SPECIFIED outcome

Timeframe: From start of study treatment until death or the date that patients were last known to be alive. An average of 56.126 weeks.

Population: All patients enrolled in the study that received at least 4 doses of investigational product were considered to this analysis.

Measured from the beginning of therapy until the date of death or for patients without a known date of death, they will be censored at the date they were last known to be alive.

Outcome measures

Outcome measures
Measure	hu3S193 n=26 Participants hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
Overall Survival	67.214 weeks Interval 4.714 to 131.143

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months from the start of study treatment.

Population: All patients enrolled in the study that received at least 4 doses of investigational product were considered to this analysis.

Rate of patients alive 12 months after starting therapy with the investigational product.

Outcome measures

Outcome measures
Measure	hu3S193 n=26 Participants hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
12-Month Survival Rate	57.7 percentage of participants Interval 38.7 to 76.7

POST_HOC outcome

Timeframe: From the first day of the investigational product administration until documentation of disease progression or death due to any cause (whichever occurred first) while the patient was on treatment, non-treatment period, or during the long-term follow-up.

Population: All patients enrolled in the study that received at least 4 doses of investigational product were considered to this analysis.

Progression free survival (PFS) is defined as the duration of time from start of treatment to time of disease progression.

Outcome measures

Outcome measures
Measure	hu3S193 n=26 Participants hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
Progression Free Survival in Patients With and Without Ascites at Baseline PFS in patients with ascites at baseline (n=9)	6.0000 weeks Interval 4.7143 to 8.2857
Progression Free Survival in Patients With and Without Ascites at Baseline PFS in patients without ascites at baseline (n=17)	16.1429 weeks Interval 7.1429 to 32.0

POST_HOC outcome

Population: All patients enrolled in the study that received at least 4 doses of investigational product and that were assessed for visceral disease at baseline were considered for this analysis.

Progression free survival (PFS) is defined as the duration of time from start of treatment to time of disease progression

Outcome measures

Outcome measures
Measure	hu3S193 n=25 Participants hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
Progression Free Survival in Patients With and Without Visceral Disease at Baseline PFS in patients with visceral disease (n=5)	6.1429 weeks Interval 4.1429 to 28.0
Progression Free Survival in Patients With and Without Visceral Disease at Baseline PFS in patients without visceral disease (n=20)	8.9286 weeks Interval 5.4286 to 18.2857

POST_HOC outcome

Population: All patients enrolled in the study that received at least 4 doses of investigational product and that were assessed for visceral disease and ascites at baseline were considered for this analysis.

Progression free survival (PFS) is defined as the duration of time from start of treatment to time of disease progression.

Outcome measures

Outcome measures
Measure	hu3S193 n=25 Participants hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
Progression Free Survival in Patients Without Ascites and no Visceral Disease at Baseline Versus Patients With Ascites and/or Visceral Disease at Baseline Without ascites and no visceral disease (n=13)	16.1429 weeks Interval 7.1429 to 32.0
Progression Free Survival in Patients Without Ascites and no Visceral Disease at Baseline Versus Patients With Ascites and/or Visceral Disease at Baseline With ascites and/or visceral disease (n=12)	6.0714 weeks Interval 4.7143 to 8.2857

Adverse Events

hu3S193

Serious events: 9 serious events

Other events: 31 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	hu3S193 n=31 participants at risk hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
Gastrointestinal disorders Intestinal obstruction	6.5% 2/31 • Number of events 3 • From the first dose of investigational product up to 30 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings.
General disorders Asthenia; Performance status decreased	3.2% 1/31 • Number of events 1 • From the first dose of investigational product up to 30 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings.
Infections and infestations Bacteraemia	3.2% 1/31 • Number of events 1 • From the first dose of investigational product up to 30 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings.
Gastrointestinal disorders Constipation	3.2% 1/31 • Number of events 1 • From the first dose of investigational product up to 30 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings.
Psychiatric disorders Depression	3.2% 1/31 • Number of events 1 • From the first dose of investigational product up to 30 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings.
Reproductive system and breast disorders Genital haemorrhage	3.2% 1/31 • Number of events 1 • From the first dose of investigational product up to 30 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	3.2% 1/31 • Number of events 1 • From the first dose of investigational product up to 30 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings.
Respiratory, thoracic and mediastinal disorders Pleural effusion	3.2% 1/31 • Number of events 1 • From the first dose of investigational product up to 30 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	3.2% 1/31 • Number of events 1 • From the first dose of investigational product up to 30 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings.
Infections and infestations Sepsis	3.2% 1/31 • Number of events 1 • From the first dose of investigational product up to 30 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings.
Nervous system disorders Syncope	3.2% 1/31 • Number of events 1 • From the first dose of investigational product up to 30 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings.
Gastrointestinal disorders Vomiting	3.2% 1/31 • Number of events 1 • From the first dose of investigational product up to 30 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings.

Other adverse events

Other adverse events
Measure	hu3S193 n=31 participants at risk hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
Gastrointestinal disorders Nausea	41.9% 13/31 • Number of events 21 • From the first dose of investigational product up to 30 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings.
Gastrointestinal disorders Vomiting	41.9% 13/31 • Number of events 26 • From the first dose of investigational product up to 30 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings.
Gastrointestinal disorders Abdominal pain	38.7% 12/31 • Number of events 16 • From the first dose of investigational product up to 30 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings.
Gastrointestinal disorders Constipation	32.3% 10/31 • Number of events 14 • From the first dose of investigational product up to 30 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings.
Gastrointestinal disorders Diarrhoea	32.3% 10/31 • Number of events 14 • From the first dose of investigational product up to 30 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings.
General disorders Fatigue	25.8% 8/31 • Number of events 15 • From the first dose of investigational product up to 30 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings.
Musculoskeletal and connective tissue disorders Pain in extremity	25.8% 8/31 • Number of events 10 • From the first dose of investigational product up to 30 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings.
Respiratory, thoracic and mediastinal disorders Cough	19.4% 6/31 • Number of events 6 • From the first dose of investigational product up to 30 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings.
General disorders Pyrexia	19.4% 6/31 • Number of events 8 • From the first dose of investigational product up to 30 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings.
Gastrointestinal disorders Anorexia	16.1% 5/31 • Number of events 10 • From the first dose of investigational product up to 30 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings.
Investigations Haemoglobin abnormal	16.1% 5/31 • Number of events 9 • From the first dose of investigational product up to 30 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings.
General disorders Influenza like illness	16.1% 5/31 • Number of events 6 • From the first dose of investigational product up to 30 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings.
Nervous system disorders Tremor	16.1% 5/31 • Number of events 5 • From the first dose of investigational product up to 30 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings.
Gastrointestinal disorders Abdominal distension	12.9% 4/31 • Number of events 6 • From the first dose of investigational product up to 30 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings.
Musculoskeletal and connective tissue disorders Back pain	12.9% 4/31 • Number of events 5 • From the first dose of investigational product up to 30 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings.
Gastrointestinal disorders Dyspepsia	12.9% 4/31 • Number of events 5 • From the first dose of investigational product up to 30 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings.
Nervous system disorders Headache	12.9% 4/31 • Number of events 5 • From the first dose of investigational product up to 30 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings.
General disorders Oedema peripheral	12.9% 4/31 • Number of events 4 • From the first dose of investigational product up to 30 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings.
Reproductive system and breast disorders Vaginal haemorrhage	12.9% 4/31 • Number of events 6 • From the first dose of investigational product up to 30 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings.
General disorders Chest pain	9.7% 3/31 • Number of events 4 • From the first dose of investigational product up to 30 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings.
Gastrointestinal disorders Dry mouth	9.7% 3/31 • Number of events 3 • From the first dose of investigational product up to 30 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings.
Respiratory, thoracic and mediastinal disorders Dyspnoea	9.7% 3/31 • Number of events 7 • From the first dose of investigational product up to 30 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings.
Immune system disorders Hypersensitivity	9.7% 3/31 • Number of events 5 • From the first dose of investigational product up to 30 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings.
Vascular disorders Hypertension	9.7% 3/31 • Number of events 10 • From the first dose of investigational product up to 30 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings.
Psychiatric disorders Insomnia	9.7% 3/31 • Number of events 3 • From the first dose of investigational product up to 30 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings.
Infections and infestations Upper respiratory tract infection	9.7% 3/31 • Number of events 3 • From the first dose of investigational product up to 30 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings.
Infections and infestations Urinary tract infection	9.7% 3/31 • Number of events 3 • From the first dose of investigational product up to 30 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings.
Skin and subcutaneous tissue disorders Urticaria	9.7% 3/31 • Number of events 3 • From the first dose of investigational product up to 30 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings.
General disorders Catheter site pain	6.5% 2/31 • Number of events 2 • From the first dose of investigational product up to 30 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings.
Renal and urinary disorders Dysuria	6.5% 2/31 • Number of events 2 • From the first dose of investigational product up to 30 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings.
Gastrointestinal disorders Intestinal obstruction	6.5% 2/31 • Number of events 4 • From the first dose of investigational product up to 30 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings.
Musculoskeletal and connective tissue disorders Muscle spasms	6.5% 2/31 • Number of events 3 • From the first dose of investigational product up to 30 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings.
Respiratory, thoracic and mediastinal disorders Pleural effusion	6.5% 2/31 • Number of events 3 • From the first dose of investigational product up to 30 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	6.5% 2/31 • Number of events 3 • From the first dose of investigational product up to 30 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings.
Infections and infestations Sinusitis	6.5% 2/31 • Number of events 2 • From the first dose of investigational product up to 30 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings.

Additional Information

Dr. Oren Smaletz, M.D., Medical Director

Recepta Biopharma

Phone: 55 11 3709-2140

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60