Trial Outcomes & Findings for A Drug-Interaction Study of Necitumumab (IMC-11F8) in Combination With Gemcitabine-Cisplatin (NCT NCT01606748)
NCT ID: NCT01606748
Last Updated: 2019-09-30
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
Run-In Period Day 3 Cohort 1: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 Hour (h) Post Start of Infusion; Cycle 1, Day 1: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of Infusion
Results posted on
2019-09-30
Participant Flow
Cohort 1 'completers' completed the PK run-in period (3 Weeks) and Cycle 1, Day 1 and Cohort 2 'completers' completed the PK run-in period.
Participant milestones
| Measure |
Necitumumab Cohort 1
Necitumumab administered on Day 3 of the 3-week PK run-in period as an intravenous (IV) infusion at an absolute dose of 800 milligrams (mg). Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.
Participants in Cohort 1 received necitumumab Process C drug product. Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/square meter (m2).
Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2.
|
Necitumumab Cohort 2
Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.
Participants in Cohort 2 received necitumumab drug product manufactured using a new and comparable necitumumab drug substance (Process D drug product).
Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.
Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
17
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
18
|
17
|
|
Overall Study
COMPLETED
|
15
|
17
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
Necitumumab Cohort 1
Necitumumab administered on Day 3 of the 3-week PK run-in period as an intravenous (IV) infusion at an absolute dose of 800 milligrams (mg). Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.
Participants in Cohort 1 received necitumumab Process C drug product. Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/square meter (m2).
Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2.
|
Necitumumab Cohort 2
Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.
Participants in Cohort 2 received necitumumab drug product manufactured using a new and comparable necitumumab drug substance (Process D drug product).
Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.
Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Progressive Disease
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
A Drug-Interaction Study of Necitumumab (IMC-11F8) in Combination With Gemcitabine-Cisplatin
Baseline characteristics by cohort
| Measure |
Necitumumab Cohort 1
n=18 Participants
Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.
Participants in Cohort 1 received necitumumab Process C drug product and participants in Cohort 2 received necitumumab Process D drug product.
Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.
Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2.
|
Necitumumab Cohort 2
n=17 Participants
Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.
Participants in Cohort 1 received necitumumab Process C drug product and participants in Cohort 2 received necitumumab Process D drug product.
Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.
Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2.
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.3 years
STANDARD_DEVIATION 15.54 • n=5 Participants
|
58.2 years
STANDARD_DEVIATION 13.84 • n=7 Participants
|
56.7 years
STANDARD_DEVIATION 14.59 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
17 participants
n=7 Participants
|
35 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) at Baseline
0
|
9 participants
n=5 Participants
|
7 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) at Baseline
1
|
9 participants
n=5 Participants
|
10 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) at Baseline
>=2
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Disease Characteristics - Tumor Type
Breast Carcinoma
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Disease Characteristics - Tumor Type
Ovarian Carcinoma
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Disease Characteristics - Tumor Type
Small Cell Lung Carcinoma
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Disease Characteristics - Tumor Type
Thymic Tumor
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Disease Characteristics - Tumor Type
Nonsmall Cell Lung Carcinoma
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Disease Characteristics - Tumor Type
Melanoma
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Disease Characteristics - Tumor Type
Head and Neck Carcinoma
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Disease Characteristics - Tumor Type
Endometrial Carcinoma
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Disease Characteristics - Tumor Type
Hepatobilliary Carcinoma
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Disease Characteristics - Tumor Type
Left Parotid
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Disease Characteristics - Tumor Type
Liver
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Disease Characteristics - Tumor Type
Granulosa Cell Tumor of the Ovary
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Disease Characteristics - Tumor Type
Mesothelioma
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Disease Characteristics - Tumor Type
Neuroendocrine Tumor
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Disease Characteristics - Tumor Type
Hepatocellular Carcinoma
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Disease Characteristics - Tumor Type
Esophageal Carcinoma
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Disease Characteristics - Tumor Type
Colorectal Carcinoma
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Disease Characteristics - Tumor Type
Sarcoma, soft tissue
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Disease Characteristics - Tumor Type
Adenocarcinoma of the Ampula of Vater
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Disease Characteristics - Tumor Type
Pancreatic Carcinoma
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Prior Anti-Cancer Therapy
Any Prior Radiotherapy
|
13 participants
n=5 Participants
|
10 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Prior Anti-Cancer Therapy
Any Prior (Adjuvant/Neoadjuvant) Systemic Therapy
|
17 participants
n=5 Participants
|
16 participants
n=7 Participants
|
33 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Run-In Period Day 3 Cohort 1: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 Hour (h) Post Start of Infusion; Cycle 1, Day 1: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of InfusionPopulation: All participants who received at least one dose of study drug and had evaluable data for PK.
Outcome measures
| Measure |
Necitumumab Cohort 1 Day 3 Run-in
n=18 Participants
Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Participants in Cohort 1 received necitumumab Process C drug product.
|
Necitumumab Cohort 1 Day 1, Cycle 1, Combination
n=12 Participants
Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg. Participants in Cohort 1 received necitumumab Process C drug product.
|
|---|---|---|
|
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Necitumumab
|
277 microgram/milliliter (ug/mL)
Geometric Coefficient of Variation 22
|
315 microgram/milliliter (ug/mL)
Geometric Coefficient of Variation 23
|
PRIMARY outcome
Timeframe: Run-In Period Day 1 Cohort 1: 0,0.5,1,1.5,3,4,6.67 and 24h Post Start of Infusion; Cycle 1, Day 1: 0, 0.50, 1, 1.5, 3, 4.67, 6.67 and 24 h Post Start of InfusionPopulation: All participants who received at least one dose of study drug and had evaluable data for PK. Per protocol, no data were collected for this assessment for participants in Cohort 2.
Outcome measures
| Measure |
Necitumumab Cohort 1 Day 3 Run-in
n=18 Participants
Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Participants in Cohort 1 received necitumumab Process C drug product.
|
Necitumumab Cohort 1 Day 1, Cycle 1, Combination
n=12 Participants
Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg. Participants in Cohort 1 received necitumumab Process C drug product.
|
|---|---|---|
|
PK: Dose-Normalized Cmax of Gemcitabine
|
4.83 nanogram(ng)/mL/mg
Geometric Coefficient of Variation 66
|
7.87 nanogram(ng)/mL/mg
Geometric Coefficient of Variation 43
|
PRIMARY outcome
Timeframe: Run-In Period Day 1 Cohort 1: 0, 2, 2.03, 2.25, 3, 3.67 and 5.67 h Post Start of Infusion; Cycle 1, Day 1: 0, 2, 2.03, 2.25, 3, 3.67 and 5.67 h Post Start of InfusionPopulation: All participants who received at least one dose of study drug and had evaluable data for PK. Per protocol, no data were collected for this assessment for participants in Cohort 2.
Outcome measures
| Measure |
Necitumumab Cohort 1 Day 3 Run-in
n=18 Participants
Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Participants in Cohort 1 received necitumumab Process C drug product.
|
Necitumumab Cohort 1 Day 1, Cycle 1, Combination
n=12 Participants
Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg. Participants in Cohort 1 received necitumumab Process C drug product.
|
|---|---|---|
|
PK: Dose-Normalized Cmax of Cisplatin
|
19.2 nanogram (ng)/mL/mg
Geometric Coefficient of Variation 21
|
22.1 nanogram (ng)/mL/mg
Geometric Coefficient of Variation 30
|
PRIMARY outcome
Timeframe: Run-In Period Day 3 Cohort 1: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of Infusion; Cycle 1, Day 1: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of InfusionPopulation: All participants who received at least one dose of study drug and had evaluable data for PK. Per protocol, no data were collected for this assessment for participants in Cohort 2.
Outcome measures
| Measure |
Necitumumab Cohort 1 Day 3 Run-in
n=18 Participants
Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Participants in Cohort 1 received necitumumab Process C drug product.
|
Necitumumab Cohort 1 Day 1, Cycle 1, Combination
n=11 Participants
Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg. Participants in Cohort 1 received necitumumab Process C drug product.
|
|---|---|---|
|
PK: Area Under Concentration-Time Curve From Zero to Time 168 (AUC[-168]) of Necitumumab
|
21900 ug*hour(h)/mL
Geometric Coefficient of Variation 24
|
22900 ug*hour(h)/mL
Geometric Coefficient of Variation 34
|
PRIMARY outcome
Timeframe: Run-In Period Day 1 Cohort 1: 0,0.5,1,1.5,3,4,6.67 and 24h Post Start of Infusion; Cycle 1, Day 1: 0, 0.50, 1, 1.5, 3, 4.67, 6.67 and 24 h Post Start of InfusionPopulation: All participants who received at least one dose of study drug and had evaluable data for PK. Per protocol, no data were collected for this assessment for participants in Cohort 2.
Outcome measures
| Measure |
Necitumumab Cohort 1 Day 3 Run-in
n=17 Participants
Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Participants in Cohort 1 received necitumumab Process C drug product.
|
Necitumumab Cohort 1 Day 1, Cycle 1, Combination
n=9 Participants
Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg. Participants in Cohort 1 received necitumumab Process C drug product.
|
|---|---|---|
|
PK: Dose-Normalized AUC(0-24) of Gemcitabine
|
2.71 ng*h/mL/mg
Geometric Coefficient of Variation 45
|
3.31 ng*h/mL/mg
Geometric Coefficient of Variation 33
|
PRIMARY outcome
Timeframe: Run-In Period Day 1 Cohort 1: 0, 2, 2.03, 2.25, 3, 3.67 and 5.67 h Post Start of Infusion; Cycle 1, Day 1: 0, 2, 2.03, 2.25, 3, 3.67 and 5.67 h Post Start of InfusionPopulation: All participants who received at least one dose of study drug and had evaluable data for PK. Per protocol, no data were collected for this assessment for participants in Cohort 2.
Outcome measures
| Measure |
Necitumumab Cohort 1 Day 3 Run-in
n=17 Participants
Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Participants in Cohort 1 received necitumumab Process C drug product.
|
Necitumumab Cohort 1 Day 1, Cycle 1, Combination
n=12 Participants
Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg. Participants in Cohort 1 received necitumumab Process C drug product.
|
|---|---|---|
|
PK: Dose-Normalized AUC(0-5) of Cisplatin
|
61.5 ng*h/mL/mg
Geometric Coefficient of Variation 20
|
67.3 ng*h/mL/mg
Geometric Coefficient of Variation 24
|
PRIMARY outcome
Timeframe: Run-In Period Day 3 Cohort 1: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of Infusion; Cycle 1 Day 1: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of InfusionPopulation: All participants who received at least one dose of study drug and had evaluable data for PK.
Outcome measures
| Measure |
Necitumumab Cohort 1 Day 3 Run-in
n=14 Participants
Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Participants in Cohort 1 received necitumumab Process C drug product.
|
Necitumumab Cohort 1 Day 1, Cycle 1, Combination
n=8 Participants
Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg. Participants in Cohort 1 received necitumumab Process C drug product.
|
|---|---|---|
|
PK: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity, (AUC[0-∞]) of Necitumumab
|
33800 ug*h/mL
Geometric Coefficient of Variation 33
|
26400 ug*h/mL
Geometric Coefficient of Variation 30
|
PRIMARY outcome
Timeframe: Run-In Period Day 1 Cohort 1: 0,0.5,1,1.5,3,4,6.67 and 24h Post Start of Infusion; Cycle 1, Day 1: 0, 0.50, 1, 1.5, 3, 4.67, 6.67 and 24 h Post Start of InfusionPopulation: All participants who received at least one dose of study drug and had evaluable data for PK. Per protocol, no data were collected for this assessment for participants in Cohort 2.
Outcome measures
| Measure |
Necitumumab Cohort 1 Day 3 Run-in
n=17 Participants
Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Participants in Cohort 1 received necitumumab Process C drug product.
|
Necitumumab Cohort 1 Day 1, Cycle 1, Combination
n=9 Participants
Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg. Participants in Cohort 1 received necitumumab Process C drug product.
|
|---|---|---|
|
PK: Dose Normalized AUC(0-∞) of Gemcitabine
|
2.72 ng*h/mL/mg
Geometric Coefficient of Variation 45
|
3.32 ng*h/mL/mg
Geometric Coefficient of Variation 33
|
SECONDARY outcome
Timeframe: Baseline through, 30-Day Follow-UpPopulation: All participants who received at least one dose of study drug and had evaluable baseline and postbaseline data for antibodies.
A participant was considered to have an anti-necitumumab antibody response if anti-drug antibodies (ADA) were confirmed positive. Treatment emergent antibodies were defined as any anti-necitumumab antibody titer equal to or greater than 4-fold the participant's baseline titer.
Outcome measures
| Measure |
Necitumumab Cohort 1 Day 3 Run-in
n=18 Participants
Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Participants in Cohort 1 received necitumumab Process C drug product.
|
Necitumumab Cohort 1 Day 1, Cycle 1, Combination
n=17 Participants
Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg. Participants in Cohort 1 received necitumumab Process C drug product.
|
|---|---|---|
|
Number of Participants With Anti-Necitumumab Antibodies
ADA Positive
|
3 participants with immunogenicity samples
|
0 participants with immunogenicity samples
|
|
Number of Participants With Anti-Necitumumab Antibodies
TE Antibodies
|
1 participants with immunogenicity samples
|
0 participants with immunogenicity samples
|
|
Number of Participants With Anti-Necitumumab Antibodies
Neutralizing Antibodies
|
0 participants with immunogenicity samples
|
0 participants with immunogenicity samples
|
SECONDARY outcome
Timeframe: Baseline to Measured Progressive Disease (Up to 14 Months)Population: All participants who received at least one dose of study drug.
ORR is confirmed best overall tumor response of CR or PR. According to RECIST v1.1, CR was defined as the disappearance of all target and non-target lesions; PR defined as a \>30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD. Percentage of participants was calculated as: (total number of participants with CR or PR from start of the treatment until disease progression or recurrence)/total number of participants treated) \* 100.
Outcome measures
| Measure |
Necitumumab Cohort 1 Day 3 Run-in
n=18 Participants
Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Participants in Cohort 1 received necitumumab Process C drug product.
|
Necitumumab Cohort 1 Day 1, Cycle 1, Combination
n=17 Participants
Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg. Participants in Cohort 1 received necitumumab Process C drug product.
|
|---|---|---|
|
Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR]) (Antitumor Activity of Necitumumab in Combination With Gemcitabine-cisplatin Chemotherapy)
|
16.7 percentage of participants
Interval 3.6 to 41.4
|
5.9 percentage of participants
Interval 0.1 to 28.7
|
SECONDARY outcome
Timeframe: Run-In Period Day 3 Cohort 1 and Cohort 2: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of InfusionPopulation: All participants who received at least one dose of study drug and had evaluable data for PK.
Outcome measures
| Measure |
Necitumumab Cohort 1 Day 3 Run-in
n=18 Participants
Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Participants in Cohort 1 received necitumumab Process C drug product.
|
Necitumumab Cohort 1 Day 1, Cycle 1, Combination
n=17 Participants
Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg. Participants in Cohort 1 received necitumumab Process C drug product.
|
|---|---|---|
|
PK: Cmax of Necitumumab After Administration of Process C and Process D Drug Product
|
277 ug/mL
Geometric Coefficient of Variation 22
|
300 ug/mL
Geometric Coefficient of Variation 36
|
SECONDARY outcome
Timeframe: Run-In Period Day 3 Cohort 1 and Cohort 2: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of InfusionPopulation: All participants who received at least one dose of study drug and had evaluable data for PK.
Outcome measures
| Measure |
Necitumumab Cohort 1 Day 3 Run-in
n=14 Participants
Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Participants in Cohort 1 received necitumumab Process C drug product.
|
Necitumumab Cohort 1 Day 1, Cycle 1, Combination
n=14 Participants
Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg. Participants in Cohort 1 received necitumumab Process C drug product.
|
|---|---|---|
|
PK: AUC(0-∞) of Necitumumab After Administration of Process C and Process D Drug Product
|
33800 ug*h/mL
Geometric Coefficient of Variation 33
|
35500 ug*h/mL
Geometric Coefficient of Variation 35
|
Adverse Events
Necitumumab Cohort 1
Serious events: 5 serious events
Other events: 18 other events
Deaths: 0 deaths
Necitumumab Cohort 2
Serious events: 8 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Necitumumab Cohort 1
n=18 participants at risk
Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.
Participants in Cohort 1 received necitumumab Process C drug product and participants in Cohort 2 received necitumumab Process D drug product.
Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.
Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2.
|
Necitumumab Cohort 2
n=17 participants at risk
Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.
Participants in Cohort 1 received necitumumab Process C drug product and participants in Cohort 2 received necitumumab Process D drug product.
Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.
Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Cardiac disorders
Acute myocardial infarction
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Eye disorders
Eye pain
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
General disorders
Asthenia
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Catheter site infection
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Implant site cellulitis
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Sepsis
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Skin infection
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Staphylococcal infection
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
11.8%
2/17 • Number of events 2
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 3
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 2
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 2
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Necitumumab Cohort 1
n=18 participants at risk
Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.
Participants in Cohort 1 received necitumumab Process C drug product and participants in Cohort 2 received necitumumab Process D drug product.
Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.
Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2.
|
Necitumumab Cohort 2
n=17 participants at risk
Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.
Participants in Cohort 1 received necitumumab Process C drug product and participants in Cohort 2 received necitumumab Process D drug product.
Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.
Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
55.6%
10/18 • Number of events 51
All participants who received at least one dose of study drug.
|
76.5%
13/17 • Number of events 50
All participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Anisocytosis
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
11.1%
2/18 • Number of events 8
All participants who received at least one dose of study drug.
|
29.4%
5/17 • Number of events 14
All participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
11.1%
2/18 • Number of events 2
All participants who received at least one dose of study drug.
|
23.5%
4/17 • Number of events 10
All participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Macrocytosis
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Microcytosis
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
44.4%
8/18 • Number of events 25
All participants who received at least one dose of study drug.
|
52.9%
9/17 • Number of events 18
All participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
61.1%
11/18 • Number of events 25
All participants who received at least one dose of study drug.
|
35.3%
6/17 • Number of events 26
All participants who received at least one dose of study drug.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
11.8%
2/17 • Number of events 2
All participants who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Deafness
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Tinnitus
|
27.8%
5/18 • Number of events 6
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Eye disorders
Asthenopia
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Eye disorders
Dry eye
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Eye disorders
Eye irritation
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Eye disorders
Eye pain
|
11.1%
2/18 • Number of events 2
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Eye disorders
Growth of eyelashes
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Eye disorders
Lacrimation increased
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Eye disorders
Photophobia
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Eye disorders
Photopsia
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Eye disorders
Trichiasis
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Eye disorders
Vision blurred
|
11.1%
2/18 • Number of events 2
All participants who received at least one dose of study drug.
|
17.6%
3/17 • Number of events 3
All participants who received at least one dose of study drug.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
11.8%
2/17 • Number of events 2
All participants who received at least one dose of study drug.
|
|
Eye disorders
Visual impairment
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
29.4%
5/17 • Number of events 5
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
17.6%
3/17 • Number of events 5
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 2
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Cheilitis
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
38.9%
7/18 • Number of events 7
All participants who received at least one dose of study drug.
|
35.3%
6/17 • Number of events 13
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
6/18 • Number of events 9
All participants who received at least one dose of study drug.
|
41.2%
7/17 • Number of events 11
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
23.5%
4/17 • Number of events 4
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
11.1%
2/18 • Number of events 2
All participants who received at least one dose of study drug.
|
11.8%
2/17 • Number of events 2
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Glossodynia
|
11.1%
2/18 • Number of events 2
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 2
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Lip disorder
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
12/18 • Number of events 15
All participants who received at least one dose of study drug.
|
58.8%
10/17 • Number of events 26
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Sensitivity of teeth
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis necrotising
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
55.6%
10/18 • Number of events 13
All participants who received at least one dose of study drug.
|
35.3%
6/17 • Number of events 16
All participants who received at least one dose of study drug.
|
|
General disorders
Asthenia
|
5.6%
1/18 • Number of events 2
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
General disorders
Catheter site haemorrhage
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
General disorders
Catheter site pain
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
General disorders
Chills
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
17.6%
3/17 • Number of events 4
All participants who received at least one dose of study drug.
|
|
General disorders
Device deployment issue
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
General disorders
Device leakage
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
77.8%
14/18 • Number of events 19
All participants who received at least one dose of study drug.
|
76.5%
13/17 • Number of events 28
All participants who received at least one dose of study drug.
|
|
General disorders
Gait disturbance
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
General disorders
Implant site erythema
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
General disorders
Implant site irritation
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
General disorders
Mucosal dryness
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
11.8%
2/17 • Number of events 2
All participants who received at least one dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
11.8%
2/17 • Number of events 2
All participants who received at least one dose of study drug.
|
|
General disorders
Oedema
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
General disorders
Oedema peripheral
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
11.8%
2/17 • Number of events 5
All participants who received at least one dose of study drug.
|
|
General disorders
Pain
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
17.6%
3/17 • Number of events 4
All participants who received at least one dose of study drug.
|
|
General disorders
Tenderness
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Immune system disorders
Multiple allergies
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Abscess neck
|
5.6%
1/18 • Number of events 2
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Abscess oral
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Bronchitis
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Cellulitis orbital
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Paronychia
|
5.6%
1/18 • Number of events 4
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
17.6%
3/17 • Number of events 6
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Excoriation
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 3
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Gastrostomy failure
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 2
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Laceration
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Wound
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
35.3%
6/17 • Number of events 7
All participants who received at least one dose of study drug.
|
|
Investigations
Alanine aminotransferase decreased
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
44.4%
8/18 • Number of events 15
All participants who received at least one dose of study drug.
|
29.4%
5/17 • Number of events 7
All participants who received at least one dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
61.1%
11/18 • Number of events 16
All participants who received at least one dose of study drug.
|
47.1%
8/17 • Number of events 12
All participants who received at least one dose of study drug.
|
|
Investigations
Blood albumin decreased
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 2
All participants who received at least one dose of study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
22.2%
4/18 • Number of events 9
All participants who received at least one dose of study drug.
|
11.8%
2/17 • Number of events 5
All participants who received at least one dose of study drug.
|
|
Investigations
Blood bilirubin increased
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Investigations
Blood cholesterol increased
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
17.6%
3/17 • Number of events 3
All participants who received at least one dose of study drug.
|
|
Investigations
Blood creatine phosphokinase increased
|
22.2%
4/18 • Number of events 4
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Investigations
Blood creatinine increased
|
22.2%
4/18 • Number of events 11
All participants who received at least one dose of study drug.
|
29.4%
5/17 • Number of events 15
All participants who received at least one dose of study drug.
|
|
Investigations
Blood fibrinogen increased
|
11.1%
2/18 • Number of events 2
All participants who received at least one dose of study drug.
|
11.8%
2/17 • Number of events 2
All participants who received at least one dose of study drug.
|
|
Investigations
Blood magnesium decreased
|
16.7%
3/18 • Number of events 3
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Investigations
Blood magnesium increased
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Investigations
Blood potassium decreased
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Investigations
Blood urea increased
|
22.2%
4/18 • Number of events 9
All participants who received at least one dose of study drug.
|
17.6%
3/17 • Number of events 3
All participants who received at least one dose of study drug.
|
|
Investigations
Blood uric acid increased
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 2
All participants who received at least one dose of study drug.
|
|
Investigations
Blood urine present
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Investigations
Carbohydrate antigen 125 increased
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Investigations
Carbohydrate antigen 19-9 increased
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
11.8%
2/17 • Number of events 2
All participants who received at least one dose of study drug.
|
|
Investigations
Carcinoembryonic antigen increased
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Investigations
Fibrin d dimer increased
|
27.8%
5/18 • Number of events 6
All participants who received at least one dose of study drug.
|
11.8%
2/17 • Number of events 3
All participants who received at least one dose of study drug.
|
|
Investigations
Glucose urine present
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Investigations
Haematocrit decreased
|
16.7%
3/18 • Number of events 4
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Investigations
Haemoglobin decreased
|
16.7%
3/18 • Number of events 5
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Investigations
International normalised ratio increased
|
16.7%
3/18 • Number of events 3
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Investigations
Lymphocyte count decreased
|
38.9%
7/18 • Number of events 13
All participants who received at least one dose of study drug.
|
29.4%
5/17 • Number of events 22
All participants who received at least one dose of study drug.
|
|
Investigations
Lymphocyte count increased
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Investigations
Monocyte count decreased
|
16.7%
3/18 • Number of events 3
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Investigations
Monocyte count increased
|
22.2%
4/18 • Number of events 5
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Investigations
Neutrophil count decreased
|
38.9%
7/18 • Number of events 24
All participants who received at least one dose of study drug.
|
23.5%
4/17 • Number of events 12
All participants who received at least one dose of study drug.
|
|
Investigations
Neutrophil count increased
|
27.8%
5/18 • Number of events 5
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Investigations
Platelet count decreased
|
44.4%
8/18 • Number of events 13
All participants who received at least one dose of study drug.
|
29.4%
5/17 • Number of events 15
All participants who received at least one dose of study drug.
|
|
Investigations
Platelet count increased
|
16.7%
3/18 • Number of events 3
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Investigations
Protein urine present
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
11.8%
2/17 • Number of events 2
All participants who received at least one dose of study drug.
|
|
Investigations
Prothrombin time prolonged
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Investigations
Red blood cell count decreased
|
11.1%
2/18 • Number of events 4
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Investigations
Urine leukocyte esterase
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Investigations
Weight decreased
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
23.5%
4/17 • Number of events 4
All participants who received at least one dose of study drug.
|
|
Investigations
Weight increased
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
11.8%
2/17 • Number of events 2
All participants who received at least one dose of study drug.
|
|
Investigations
White blood cell count decreased
|
55.6%
10/18 • Number of events 23
All participants who received at least one dose of study drug.
|
41.2%
7/17 • Number of events 15
All participants who received at least one dose of study drug.
|
|
Investigations
White blood cell count increased
|
11.1%
2/18 • Number of events 2
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
38.9%
7/18 • Number of events 7
All participants who received at least one dose of study drug.
|
41.2%
7/17 • Number of events 14
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
17.6%
3/17 • Number of events 4
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
23.5%
4/17 • Number of events 7
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
11.1%
2/18 • Number of events 4
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 3
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
22.2%
4/18 • Number of events 12
All participants who received at least one dose of study drug.
|
52.9%
9/17 • Number of events 12
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
16.7%
3/18 • Number of events 6
All participants who received at least one dose of study drug.
|
29.4%
5/17 • Number of events 8
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
44.4%
8/18 • Number of events 20
All participants who received at least one dose of study drug.
|
41.2%
7/17 • Number of events 20
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
55.6%
10/18 • Number of events 30
All participants who received at least one dose of study drug.
|
70.6%
12/17 • Number of events 32
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
22.2%
4/18 • Number of events 7
All participants who received at least one dose of study drug.
|
23.5%
4/17 • Number of events 6
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
11.1%
2/18 • Number of events 2
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Malnutrition
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Vitamin d deficiency
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
17.6%
3/17 • Number of events 3
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
11.1%
2/18 • Number of events 2
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
5.6%
1/18 • Number of events 2
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
17.6%
3/17 • Number of events 5
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Cognitive disorder
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
23.5%
4/17 • Number of events 5
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
11.1%
2/18 • Number of events 2
All participants who received at least one dose of study drug.
|
41.2%
7/17 • Number of events 10
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
22.2%
4/18 • Number of events 6
All participants who received at least one dose of study drug.
|
29.4%
5/17 • Number of events 7
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Neuropathy peripheral
|
16.7%
3/18 • Number of events 3
All participants who received at least one dose of study drug.
|
11.8%
2/17 • Number of events 2
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Presyncope
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
11.8%
2/17 • Number of events 2
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Tremor
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
11.1%
2/18 • Number of events 2
All participants who received at least one dose of study drug.
|
17.6%
3/17 • Number of events 3
All participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Depression
|
16.7%
3/18 • Number of events 4
All participants who received at least one dose of study drug.
|
11.8%
2/17 • Number of events 2
All participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
11.8%
2/17 • Number of events 2
All participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Restlessness
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
11.8%
2/17 • Number of events 2
All participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
11.8%
2/17 • Number of events 2
All participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Nocturia
|
11.1%
2/18 • Number of events 2
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
17.6%
3/17 • Number of events 3
All participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
22.2%
4/18 • Number of events 4
All participants who received at least one dose of study drug.
|
23.5%
4/17 • Number of events 4
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
27.8%
5/18 • Number of events 5
All participants who received at least one dose of study drug.
|
17.6%
3/17 • Number of events 4
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 2
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
23.5%
4/17 • Number of events 7
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
17.6%
3/17 • Number of events 3
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.6%
1/18 • Number of events 2
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 2
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
23.5%
4/17 • Number of events 4
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
11.8%
2/17 • Number of events 2
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
22.2%
4/18 • Number of events 5
All participants who received at least one dose of study drug.
|
47.1%
8/17 • Number of events 8
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.7%
3/18 • Number of events 3
All participants who received at least one dose of study drug.
|
17.6%
3/17 • Number of events 3
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
11.8%
2/17 • Number of events 2
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hirsutism
|
9.1%
1/11 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/10
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
27.8%
5/18 • Number of events 5
All participants who received at least one dose of study drug.
|
11.8%
2/17 • Number of events 2
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.6%
1/18 • Number of events 3
All participants who received at least one dose of study drug.
|
11.8%
2/17 • Number of events 3
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
27.8%
5/18 • Number of events 7
All participants who received at least one dose of study drug.
|
29.4%
5/17 • Number of events 8
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
38.9%
7/18 • Number of events 10
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 2
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
11.8%
2/17 • Number of events 3
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
11.8%
2/17 • Number of events 4
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
11.1%
2/18 • Number of events 2
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Vascular disorders
Flushing
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Vascular disorders
Hot flush
|
5.6%
1/18 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/17
All participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypertension
|
11.1%
2/18 • Number of events 2
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypotension
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/18
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1
All participants who received at least one dose of study drug.
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60