Trial Outcomes & Findings for Study of Topical SOR007 Ointment for Cutaneous Metastases (NCT NCT03101358)

Last Updated: 2021-11-05

Results Overview

Treatment emergent adverse events will include all reported adverse events, laboratory assessments, physical examination findings, and vital signs.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

23 participants

Primary outcome timeframe

Baseline through Day 59 (for 28 days of treatment) or Day 86 (for 56 days of treatment)

Results posted on

2021-11-05

Participant Flow

Participant milestones

Participant milestones
Measure	SOR007 0.15% 0.15% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.	SOR007 1.0% 1.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.	SOR007 2.0% Group A 2.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.	SOR007 2.0% Group B 2.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 56 days SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.
Overall Study STARTED	4	3	5	11
Overall Study Completed All Dosing	3	3	3	10
Overall Study COMPLETED	1	3	3	5
Overall Study NOT COMPLETED	3	0	2	6

Reasons for withdrawal

Reasons for withdrawal
Measure	SOR007 0.15% 0.15% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.	SOR007 2.0% Group A 2.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.	SOR007 2.0% Group B 2.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 56 days SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.
Overall Study Non-compliance with study schedule	1	0	1
Overall Study Decision to start another clinical trial. Not related to AE.	0	1	0
Overall Study Physician Decision	1	0	3
Overall Study Adverse Event	0	1	0
Overall Study Oncologist decision to start subject on IV chemotherapy prohibited under protocol.	0	0	1
Overall Study Lost to Follow-up	1	0	1

Baseline Characteristics

Study of Topical SOR007 Ointment for Cutaneous Metastases

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SOR007 0.15% n=4 Participants 0.15% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.	SOR007 1.0% n=3 Participants 1.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.	SOR007 2.0% Group A n=5 Participants 2.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.	SOR007 2.0% Group B n=11 Participants 2.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 56 days SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.	Total n=23 Participants Total of all reporting groups
Age, Continuous	62.8 years STANDARD_DEVIATION 12.7 • n=5 Participants	66.3 years STANDARD_DEVIATION 8.3 • n=7 Participants	63.2 years STANDARD_DEVIATION 11.3 • n=5 Participants	63.0 years STANDARD_DEVIATION 10.8 • n=4 Participants	63.4 years STANDARD_DEVIATION 10.3 • n=21 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	10 Participants n=4 Participants	21 Participants n=21 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	5 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	9 Participants n=4 Participants	17 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	6 Participants n=4 Participants	14 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants
Body Mass Index	23.23 kg/m^2 STANDARD_DEVIATION 4.51 • n=5 Participants	26.13 kg/m^2 STANDARD_DEVIATION 3.96 • n=7 Participants	29.54 kg/m^2 STANDARD_DEVIATION 4.94 • n=5 Participants	25.05 kg/m^2 STANDARD_DEVIATION 5.21 • n=4 Participants	25.85 kg/m^2 STANDARD_DEVIATION 5.07 • n=21 Participants
ECOG Performance Status	1.0 units on a scale STANDARD_DEVIATION 0.8 • n=5 Participants	0.7 units on a scale STANDARD_DEVIATION 0.6 • n=7 Participants	0.6 units on a scale STANDARD_DEVIATION 0.9 • n=5 Participants	0.7 units on a scale STANDARD_DEVIATION 0.5 • n=4 Participants	0.7 units on a scale STANDARD_DEVIATION 0.6 • n=21 Participants

PRIMARY outcome

Timeframe: Baseline through Day 59 (for 28 days of treatment) or Day 86 (for 56 days of treatment)

Population: All subjects who received SOR007 were included in the analysis population.

Treatment emergent adverse events will include all reported adverse events, laboratory assessments, physical examination findings, and vital signs.

Outcome measures

Outcome measures
Measure	SOR007 0.15% n=4 Participants 0.15% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.	SOR007 1.0% n=3 Participants 1.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.	SOR007 2.0% Group A n=5 Participants 2.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.	SOR007 2.0% Group B n=11 Participants 2.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 56 days SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.
Incidence of Treatment Emergent Adverse Events	4 Participants	3 Participants	5 Participants	10 Participants

SECONDARY outcome

Timeframe: Baseline and Day 43 (for 28 days of treatment) or Day 70 (for 56 days of treatment)

Population: Of the 23 Subjects enrolled, evaluable photography 14 days after the last dose of SOR007 was provided in 14 (60.9%) Subjects; two in the 0.15% treatment group, three in the 1.0% treatment group, four in 2.0% A treatment group, and five in 2.0% B treatment group.

Objective Clinical Response (Complete Clinical Response (CR) + Partial Response (PR)) is defined as the percentage of study subjects who achieve complete clinical response or partial response 14 days after last treatment (Day 43 or Day 70). Complete clinical response (CR) is defined as absence of any detectable residual disease in the treatment area; partial response (PR) as at least a 30% decrease in the sum of the diameters of eligible lesion(s) within the treatment area compared to baseline; progressive disease (PD) as at least a 20% increase in the sum of diameters of eligible lesion(s) within the treatment area, taking as reference the smallest sum on study (the sum must also demonstrate an absolute increase of at least 5 mm); and stable disease (SD) as between that defined as PR or PD. Eligible lesions will be determined at baseline by the RECIST definition of measurable tumors (≥ 10mm in its longest diameter).

Outcome measures

Outcome measures
Measure	SOR007 0.15% n=2 Participants 0.15% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.	SOR007 1.0% n=3 Participants 1.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.	SOR007 2.0% Group A n=4 Participants 2.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.	SOR007 2.0% Group B n=5 Participants 2.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 56 days SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.
Objective Clinical Response Progressive Disease	1 Participants	0 Participants	3 Participants	0 Participants
Objective Clinical Response Complete Response	0 Participants	0 Participants	0 Participants	1 Participants
Objective Clinical Response Partial Response	0 Participants	2 Participants	0 Participants	0 Participants
Objective Clinical Response Stable Disease	1 Participants	1 Participants	1 Participants	4 Participants

SECONDARY outcome

Timeframe: Baseline and Day 43 (for 28 days of treatment) or Day 70 (for 56 days of treatment)

Population: All subjects who received SOR007 were included in the analysis population.

Change in pain at the treatment area will be measured by the Numeric Rating Scale (NRS-11). The numerical scale ranges from 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable." A lower score equates to less severe pain (better outcome) and a higher score equates to more severe pain (worse outcome).

Outcome measures

Outcome measures
Measure	SOR007 0.15% n=4 Participants 0.15% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.	SOR007 1.0% n=3 Participants 1.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.	SOR007 2.0% Group A n=5 Participants 2.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.	SOR007 2.0% Group B n=11 Participants 2.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 56 days SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.
Change in Pain at the Treatment Area Baseline (Day 1)	0.0 units on a scale Standard Deviation 0.0	0.3 units on a scale Standard Deviation 0.6	1.4 units on a scale Standard Deviation 1.3	1.1 units on a scale Standard Deviation 2.0
Change in Pain at the Treatment Area 2 Weeks after Last Dose (Day 43 for 28-day treatment groups or Day 70 for 56-day treatment groups)	0.0 units on a scale Standard Deviation 0.0	1.0 units on a scale Standard Deviation 1.7	3.8 units on a scale Standard Deviation 2.6	0.3 units on a scale Standard Deviation 0.7

SECONDARY outcome

Timeframe: Baseline and Day 43 (for 28 days of treatment) or Day 70 (for 56 days of treatment)

Population: One subject in SOR007 2.0% Group A was not included in the analysis.

Objective Tumor Response (OTR), defined as the difference in the lesion size within the treatment area between baseline and 14 days after the last dose in the dose group i.e. Day 43 for dose escalation Subjects, and dose expansion Group A Subjects; Day 70 for dose expansion Group B Subjects; or between baseline and last tumor assessment for early terminators. Four OTRs are calculated based on different definitions of "lesion size": 1) Area of the primary eligible lesion, 2) Sum of area of all eligible lesions, 3) Longest diameter of the primary eligible lesion, and 4) Sum of longest diameter of all eligible lesions.

Outcome measures

Outcome measures
Measure	SOR007 0.15% n=4 Participants 0.15% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.	SOR007 1.0% n=3 Participants 1.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.	SOR007 2.0% Group A n=15 Participants 2.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.	SOR007 2.0% Group B 2.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 56 days SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.
Objective Tumor Response (OTR) Based on Longest Diameter of the Primary Eligible Lesion	-5.50 mm^2 Standard Deviation 9.75	5.11 mm^2 Standard Deviation 6.55	-0.96 mm^2 Standard Deviation 16.57	—
Objective Tumor Response (OTR) Based on Area of the Primary Eligible Lesion	-31.03 mm^2 Standard Deviation 22.00	302.63 mm^2 Standard Deviation 330.55	-165.05 mm^2 Standard Deviation 679.24	—
Objective Tumor Response (OTR) Based on Total Area of all Eligible Lesions	-40.57 mm^2 Standard Deviation 25.56	407.33 mm^2 Standard Deviation 499.66	-176.61 mm^2 Standard Deviation 883.76	—
Objective Tumor Response (OTR) Based on Total Longest Diameter of all Eligible Lesions	-5.75 mm^2 Standard Deviation 9.58	4.88 mm^2 Standard Deviation 6.17	1.26 mm^2 Standard Deviation 37.34	—

Adverse Events

SOR007 0.15%

Serious events: 1 serious events

Other events: 4 other events

Deaths: 1 deaths

SOR007 1.0%

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

SOR007 2.0% Group A

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

SOR007 2.0% Group B

Serious events: 4 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	SOR007 0.15% n=4 participants at risk 0.15% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.	SOR007 1.0% n=3 participants at risk 1.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.	SOR007 2.0% Group A n=5 participants at risk 2.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.	SOR007 2.0% Group B n=11 participants at risk 2.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 56 days SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.
General disorders Chest pain	0.00% 0/4 • The Investigator recorded all reportable events with start dates occurring any time after first study drug dose application until 30 days after the last study drug application, or in the case of an TESAE, at least 30 days after onset, whichever was later. AEs were collected at all study visits from the time of first study drug application. Study personnel were required to review the Subject's diary at each visit to confirm it was adequately completed and to address and document discrepancies, missing entries and errors. Study personnel also asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/3 • The Investigator recorded all reportable events with start dates occurring any time after first study drug dose application until 30 days after the last study drug application, or in the case of an TESAE, at least 30 days after onset, whichever was later. AEs were collected at all study visits from the time of first study drug application. Study personnel were required to review the Subject's diary at each visit to confirm it was adequately completed and to address and document discrepancies, missing entries and errors. Study personnel also asked open-ended questions to obtain information about AEs at every visit.	20.0% 1/5 • Number of events 1 • The Investigator recorded all reportable events with start dates occurring any time after first study drug dose application until 30 days after the last study drug application, or in the case of an TESAE, at least 30 days after onset, whichever was later. AEs were collected at all study visits from the time of first study drug application. Study personnel were required to review the Subject's diary at each visit to confirm it was adequately completed and to address and document discrepancies, missing entries and errors. Study personnel also asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/11 • The Investigator recorded all reportable events with start dates occurring any time after first study drug dose application until 30 days after the last study drug application, or in the case of an TESAE, at least 30 days after onset, whichever was later. AEs were collected at all study visits from the time of first study drug application. Study personnel were required to review the Subject's diary at each visit to confirm it was adequately completed and to address and document discrepancies, missing entries and errors. Study personnel also asked open-ended questions to obtain information about AEs at every visit.
Infections and infestations Medical device site infection	0.00% 0/4 • The Investigator recorded all reportable events with start dates occurring any time after first study drug dose application until 30 days after the last study drug application, or in the case of an TESAE, at least 30 days after onset, whichever was later. AEs were collected at all study visits from the time of first study drug application. Study personnel were required to review the Subject's diary at each visit to confirm it was adequately completed and to address and document discrepancies, missing entries and errors. Study personnel also asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/3 • The Investigator recorded all reportable events with start dates occurring any time after first study drug dose application until 30 days after the last study drug application, or in the case of an TESAE, at least 30 days after onset, whichever was later. AEs were collected at all study visits from the time of first study drug application. Study personnel were required to review the Subject's diary at each visit to confirm it was adequately completed and to address and document discrepancies, missing entries and errors. Study personnel also asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/5 • The Investigator recorded all reportable events with start dates occurring any time after first study drug dose application until 30 days after the last study drug application, or in the case of an TESAE, at least 30 days after onset, whichever was later. AEs were collected at all study visits from the time of first study drug application. Study personnel were required to review the Subject's diary at each visit to confirm it was adequately completed and to address and document discrepancies, missing entries and errors. Study personnel also asked open-ended questions to obtain information about AEs at every visit.	9.1% 1/11 • Number of events 1 • The Investigator recorded all reportable events with start dates occurring any time after first study drug dose application until 30 days after the last study drug application, or in the case of an TESAE, at least 30 days after onset, whichever was later. AEs were collected at all study visits from the time of first study drug application. Study personnel were required to review the Subject's diary at each visit to confirm it was adequately completed and to address and document discrepancies, missing entries and errors. Study personnel also asked open-ended questions to obtain information about AEs at every visit.
Metabolism and nutrition disorders Hypercalcaemia	25.0% 1/4 • Number of events 1 • The Investigator recorded all reportable events with start dates occurring any time after first study drug dose application until 30 days after the last study drug application, or in the case of an TESAE, at least 30 days after onset, whichever was later. AEs were collected at all study visits from the time of first study drug application. Study personnel were required to review the Subject's diary at each visit to confirm it was adequately completed and to address and document discrepancies, missing entries and errors. Study personnel also asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/3 • The Investigator recorded all reportable events with start dates occurring any time after first study drug dose application until 30 days after the last study drug application, or in the case of an TESAE, at least 30 days after onset, whichever was later. AEs were collected at all study visits from the time of first study drug application. Study personnel were required to review the Subject's diary at each visit to confirm it was adequately completed and to address and document discrepancies, missing entries and errors. Study personnel also asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/5 • The Investigator recorded all reportable events with start dates occurring any time after first study drug dose application until 30 days after the last study drug application, or in the case of an TESAE, at least 30 days after onset, whichever was later. AEs were collected at all study visits from the time of first study drug application. Study personnel were required to review the Subject's diary at each visit to confirm it was adequately completed and to address and document discrepancies, missing entries and errors. Study personnel also asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/11 • The Investigator recorded all reportable events with start dates occurring any time after first study drug dose application until 30 days after the last study drug application, or in the case of an TESAE, at least 30 days after onset, whichever was later. AEs were collected at all study visits from the time of first study drug application. Study personnel were required to review the Subject's diary at each visit to confirm it was adequately completed and to address and document discrepancies, missing entries and errors. Study personnel also asked open-ended questions to obtain information about AEs at every visit.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/4 • The Investigator recorded all reportable events with start dates occurring any time after first study drug dose application until 30 days after the last study drug application, or in the case of an TESAE, at least 30 days after onset, whichever was later. AEs were collected at all study visits from the time of first study drug application. Study personnel were required to review the Subject's diary at each visit to confirm it was adequately completed and to address and document discrepancies, missing entries and errors. Study personnel also asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/3 • The Investigator recorded all reportable events with start dates occurring any time after first study drug dose application until 30 days after the last study drug application, or in the case of an TESAE, at least 30 days after onset, whichever was later. AEs were collected at all study visits from the time of first study drug application. Study personnel were required to review the Subject's diary at each visit to confirm it was adequately completed and to address and document discrepancies, missing entries and errors. Study personnel also asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/5 • The Investigator recorded all reportable events with start dates occurring any time after first study drug dose application until 30 days after the last study drug application, or in the case of an TESAE, at least 30 days after onset, whichever was later. AEs were collected at all study visits from the time of first study drug application. Study personnel were required to review the Subject's diary at each visit to confirm it was adequately completed and to address and document discrepancies, missing entries and errors. Study personnel also asked open-ended questions to obtain information about AEs at every visit.	9.1% 1/11 • Number of events 1 • The Investigator recorded all reportable events with start dates occurring any time after first study drug dose application until 30 days after the last study drug application, or in the case of an TESAE, at least 30 days after onset, whichever was later. AEs were collected at all study visits from the time of first study drug application. Study personnel were required to review the Subject's diary at each visit to confirm it was adequately completed and to address and document discrepancies, missing entries and errors. Study personnel also asked open-ended questions to obtain information about AEs at every visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	25.0% 1/4 • Number of events 1 • The Investigator recorded all reportable events with start dates occurring any time after first study drug dose application until 30 days after the last study drug application, or in the case of an TESAE, at least 30 days after onset, whichever was later. AEs were collected at all study visits from the time of first study drug application. Study personnel were required to review the Subject's diary at each visit to confirm it was adequately completed and to address and document discrepancies, missing entries and errors. Study personnel also asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/3 • The Investigator recorded all reportable events with start dates occurring any time after first study drug dose application until 30 days after the last study drug application, or in the case of an TESAE, at least 30 days after onset, whichever was later. AEs were collected at all study visits from the time of first study drug application. Study personnel were required to review the Subject's diary at each visit to confirm it was adequately completed and to address and document discrepancies, missing entries and errors. Study personnel also asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/5 • The Investigator recorded all reportable events with start dates occurring any time after first study drug dose application until 30 days after the last study drug application, or in the case of an TESAE, at least 30 days after onset, whichever was later. AEs were collected at all study visits from the time of first study drug application. Study personnel were required to review the Subject's diary at each visit to confirm it was adequately completed and to address and document discrepancies, missing entries and errors. Study personnel also asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/11 • The Investigator recorded all reportable events with start dates occurring any time after first study drug dose application until 30 days after the last study drug application, or in the case of an TESAE, at least 30 days after onset, whichever was later. AEs were collected at all study visits from the time of first study drug application. Study personnel were required to review the Subject's diary at each visit to confirm it was adequately completed and to address and document discrepancies, missing entries and errors. Study personnel also asked open-ended questions to obtain information about AEs at every visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/4 • The Investigator recorded all reportable events with start dates occurring any time after first study drug dose application until 30 days after the last study drug application, or in the case of an TESAE, at least 30 days after onset, whichever was later. AEs were collected at all study visits from the time of first study drug application. Study personnel were required to review the Subject's diary at each visit to confirm it was adequately completed and to address and document discrepancies, missing entries and errors. Study personnel also asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/3 • The Investigator recorded all reportable events with start dates occurring any time after first study drug dose application until 30 days after the last study drug application, or in the case of an TESAE, at least 30 days after onset, whichever was later. AEs were collected at all study visits from the time of first study drug application. Study personnel were required to review the Subject's diary at each visit to confirm it was adequately completed and to address and document discrepancies, missing entries and errors. Study personnel also asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/5 • The Investigator recorded all reportable events with start dates occurring any time after first study drug dose application until 30 days after the last study drug application, or in the case of an TESAE, at least 30 days after onset, whichever was later. AEs were collected at all study visits from the time of first study drug application. Study personnel were required to review the Subject's diary at each visit to confirm it was adequately completed and to address and document discrepancies, missing entries and errors. Study personnel also asked open-ended questions to obtain information about AEs at every visit.	9.1% 1/11 • Number of events 1 • The Investigator recorded all reportable events with start dates occurring any time after first study drug dose application until 30 days after the last study drug application, or in the case of an TESAE, at least 30 days after onset, whichever was later. AEs were collected at all study visits from the time of first study drug application. Study personnel were required to review the Subject's diary at each visit to confirm it was adequately completed and to address and document discrepancies, missing entries and errors. Study personnel also asked open-ended questions to obtain information about AEs at every visit.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/4 • The Investigator recorded all reportable events with start dates occurring any time after first study drug dose application until 30 days after the last study drug application, or in the case of an TESAE, at least 30 days after onset, whichever was later. AEs were collected at all study visits from the time of first study drug application. Study personnel were required to review the Subject's diary at each visit to confirm it was adequately completed and to address and document discrepancies, missing entries and errors. Study personnel also asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/3 • The Investigator recorded all reportable events with start dates occurring any time after first study drug dose application until 30 days after the last study drug application, or in the case of an TESAE, at least 30 days after onset, whichever was later. AEs were collected at all study visits from the time of first study drug application. Study personnel were required to review the Subject's diary at each visit to confirm it was adequately completed and to address and document discrepancies, missing entries and errors. Study personnel also asked open-ended questions to obtain information about AEs at every visit.	20.0% 1/5 • Number of events 1 • The Investigator recorded all reportable events with start dates occurring any time after first study drug dose application until 30 days after the last study drug application, or in the case of an TESAE, at least 30 days after onset, whichever was later. AEs were collected at all study visits from the time of first study drug application. Study personnel were required to review the Subject's diary at each visit to confirm it was adequately completed and to address and document discrepancies, missing entries and errors. Study personnel also asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/11 • The Investigator recorded all reportable events with start dates occurring any time after first study drug dose application until 30 days after the last study drug application, or in the case of an TESAE, at least 30 days after onset, whichever was later. AEs were collected at all study visits from the time of first study drug application. Study personnel were required to review the Subject's diary at each visit to confirm it was adequately completed and to address and document discrepancies, missing entries and errors. Study personnel also asked open-ended questions to obtain information about AEs at every visit.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/4 • The Investigator recorded all reportable events with start dates occurring any time after first study drug dose application until 30 days after the last study drug application, or in the case of an TESAE, at least 30 days after onset, whichever was later. AEs were collected at all study visits from the time of first study drug application. Study personnel were required to review the Subject's diary at each visit to confirm it was adequately completed and to address and document discrepancies, missing entries and errors. Study personnel also asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/3 • The Investigator recorded all reportable events with start dates occurring any time after first study drug dose application until 30 days after the last study drug application, or in the case of an TESAE, at least 30 days after onset, whichever was later. AEs were collected at all study visits from the time of first study drug application. Study personnel were required to review the Subject's diary at each visit to confirm it was adequately completed and to address and document discrepancies, missing entries and errors. Study personnel also asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/5 • The Investigator recorded all reportable events with start dates occurring any time after first study drug dose application until 30 days after the last study drug application, or in the case of an TESAE, at least 30 days after onset, whichever was later. AEs were collected at all study visits from the time of first study drug application. Study personnel were required to review the Subject's diary at each visit to confirm it was adequately completed and to address and document discrepancies, missing entries and errors. Study personnel also asked open-ended questions to obtain information about AEs at every visit.	9.1% 1/11 • Number of events 1 • The Investigator recorded all reportable events with start dates occurring any time after first study drug dose application until 30 days after the last study drug application, or in the case of an TESAE, at least 30 days after onset, whichever was later. AEs were collected at all study visits from the time of first study drug application. Study personnel were required to review the Subject's diary at each visit to confirm it was adequately completed and to address and document discrepancies, missing entries and errors. Study personnel also asked open-ended questions to obtain information about AEs at every visit.

Other adverse events

Additional Information

Gere diZerega, MD

US Biotest, Inc.

Phone: 805.595.1300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place