Trial Outcomes & Findings for A Study in Advanced Solid Tumors (NCT NCT01063075)
NCT ID: NCT01063075
Last Updated: 2019-09-26
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
34 participants
Primary outcome timeframe
Group D: Cycle 1, Week 1, Day 1; Prior to Carboplatin Infusion, 1hour (H), 1:30 H, 2 H, 3 H, 5 H, 8 H, 24 H, 72 H (after the Start of Carboplatin Infusion)
Results posted on
2019-09-26
Participant Flow
Due to protocol amendment in September 2011, any newly enrolled participants were placed into cetuximab and carboplatin (C) arm only. After protocol amendment February 2014, any newly enrolled participants were placed into Group D arm only.
Participant milestones
| Measure |
Carboplatin and Cetuximab (A)
Group A:
Cycle 1 (3 weeks, combination therapy):
Carboplatin (AUC=5) administered I.V on week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1.
400 milligrams per square meter (mg/m ²) cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3, day 1.
Cycle 2 (3 weeks, combination therapy):
Carboplatin (AUC=5) administered I.V on week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1. 250 mg/m ² cetuximab administered I.V on weeks 1- 3, day 1.
|
Cetuximab and Carboplatin (B)
Group B:
Cycle 1 (3 weeks, single-agent cetuximab):
400 mg/m² cetuximab administered I.V on week 1, day 1. 250 mg/m ² cetuximab administered I.V on weeks 2 and 3, day 1.
Cycle 2 (3 weeks, combination therapy):
Carboplatin (AUC=5) administered I.V week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1. 250 mg/m ² cetuximab administered I.V weeks 1- 3,day 1.
|
Cetuximab and Carboplatin (C)
Group C:
Cycle 1 (4 weeks, combination therapy):
Carboplatin (AUC=5) administered I.V on week 1, day 1.1000 mg/m ²/day 5-FU administered as a 96-hour C.I. starting on week 1, day 1.
400 mg/m² cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3 and 4, day 1.
Cycle 2-6 (3 weeks, combination therapy):
Carboplatin (AUC=5) administered I.V on week1,day1.1000 mg/m ²/d 5-FU as a 96-hour C.I. starting on week1, day1. 250 mg/m ² cetuximab administered I.V on Week 1-3, day 1.
|
Cetuximab and Carboplatin (D)
Cycle 1 (1 week, combination therapy):
400 milligrams per square meter (mg/m ²) cetuximab administered intravenously (I.V) on week 1, day 1. Carboplatin area under the curve (AUC=5) administered I.V on week 1, day 1.
Optional 5- fluorouracil (FU) administered as a 96-hour continuous infusion (C.I.) of 1000 mg/ m ²/day administered starting on week 1, day 1.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
3
|
14
|
15
|
|
Overall Study
COMPLETED
|
1
|
1
|
9
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
5
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study in Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
All Participants (Group A, B, C and D)
n=34 Participants
Group D:
Cycle 1:400 mg/m² cetuximab week (w) 1,day(d) 1.Carboplatin(AUC=5) on w 1, d 1.Optional 1000 mg/m²/d 5-FU given as a 96-hour C.I. starting(strt) on w 1, d 1.
Group C:
Cycle 1:Carboplatin(AUC=5) on w 1,d 1. 400 mg/m² cetuximab on w 2, d 1.Cetuximab 250 mg/m ² on w 3 and 4, d 1.
Cycle 2-6:Carboplatin(AUC=5) and 250 mg/m² cetuximab on w 1, d 1.1000 mg/m²/d 5-FU given as a 96-hour C.I. strt on w 1, d 1.250 mg/m² cetuximab on w 2 and 3, d 1.
Group B:
Cycle 1:400 mg/m² cetuximab on w 1, d 1. 250 mg/m ² cetuximab on w 2 and 3, d 1.
Cycle 2:Carboplatin(AUC=5) w 1, d 1.1000 mg/m ²/d 5-FU given as 96-hour C.I. strt on w 1, d 1. 250 mg/m ² cetuximab w 1- 3, d 1.
Group A:
Cycle 1:Carboplatin(AUC=5) on w 1, d 1. 1000 mg/m²/d 5-FU given as 96-hour C.I. strt on w 1, d 1.
400 mg/m² cetuximab on w 2, d 1 and 250 mg/m² cetuximab on w 3, d 1. Cycle 2:Carboplatin(AUC=5) given I.V on w 1, d 1.1000 mg/m²/d 5-FU given as 96-hour C.I. strt on w 1, d 1. 250 mg/m² cetuximab on w 1-3, d 1.
|
|---|---|
|
Age, Continuous
|
58.20 years
STANDARD_DEVIATION 12.88 • n=93 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
|
Region of Enrollment
Canada
|
10 participants
n=93 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Group D: Cycle 1, Week 1, Day 1; Prior to Carboplatin Infusion, 1hour (H), 1:30 H, 2 H, 3 H, 5 H, 8 H, 24 H, 72 H (after the Start of Carboplatin Infusion)Population: Participants who received at least 1 dose of study drug who were enrolled in Group(Grp)D \& had evaluable PK data.Study design by intent did not collect data from Grp B.Due to participant recruitment \& retention challenges,there were no PK study completers for Grp A \& C.Participant recruitment \& retention addressed by amending protocol to add Grp D.
Outcome measures
| Measure |
Cetuximab and Carboplatin (D)
n=13 Participants
Group D:
Cycle 1 (1 week, combination therapy):
400 milligrams per square meter (mg/m ²) cetuximab administered intravenously (I.V) on week 1, day 1. Carboplatin area under the curve (AUC=5) administered I.V on week 1, day 1.
Optional 5- fluorouracil (FU) administered as a 96-hour continuous infusion (C.I.) of 1000 mg/ m ²/day administered starting on week 1, day 1.
|
Cetuximab and Carboplatin (B and C)
Group B:
Cycle 1 (3 weeks, single-agent cetuximab):
400 mg/m² cetuximab administered I.V on week 1, day 1. 250 mg/m ² cetuximab administered I.V on weeks 2 and 3, day 1.
Cycle 2 (3 weeks, combination therapy):
Carboplatin (AUC=5) administered I.V week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1. 250 mg/m ² cetuximab administered I.V weeks 1- 3,day 1.
Group C:
Cycle 1 (4 weeks, combination therapy):
Carboplatin (AUC=5) administered I.V on week 1, day 1.1000 mg/m ²/day 5-FU administered as a 96-hour C.I. starting on week 1, day 1.
400 mg/m² cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3 and 4, day 1.
Cycle 2-6 (3 weeks, combination therapy):
Carboplatin (AUC=5) administered I.V on week1,day1.1000 mg/m ²/d 5-FU as a 96-hour C.I. starting on week1, day1. 250 mg/m ² cetuximab administered I.V on Week 1-3, day 1.
|
|---|---|---|
|
Total Carboplatin Pharmacokinetics (PK): Area Under the Concentration (AUC) Versus Time Curve From Time Zero to Infinity (AUC[0-∞])
|
129 micrograms*hour/milliliters (μg•h/mL)
Geometric Coefficient of Variation 14.8
|
—
|
PRIMARY outcome
Timeframe: (Group B: Cycle 1 and Cycle 2+ ; Day 1, 8, 15 and Group C: Cycle 1, Day 8, 15 and 22; Cycle 2+, Day 1,8 and 15): Prior to Cetuximab Infusion, 1 Hour (H), 2 H, 4 H, 8 H, 24 H, 72 H, 120 H, and 168 H (after the start of Cetuximab Infusion)Population: All participants who received at least one dose of study drug who were enrolled in Group B and C and had evaluable PK data. Study design by intent did not collect data from Groups D and A.
Outcome measures
| Measure |
Cetuximab and Carboplatin (D)
n=5 Participants
Group D:
Cycle 1 (1 week, combination therapy):
400 milligrams per square meter (mg/m ²) cetuximab administered intravenously (I.V) on week 1, day 1. Carboplatin area under the curve (AUC=5) administered I.V on week 1, day 1.
Optional 5- fluorouracil (FU) administered as a 96-hour continuous infusion (C.I.) of 1000 mg/ m ²/day administered starting on week 1, day 1.
|
Cetuximab and Carboplatin (B and C)
n=5 Participants
Group B:
Cycle 1 (3 weeks, single-agent cetuximab):
400 mg/m² cetuximab administered I.V on week 1, day 1. 250 mg/m ² cetuximab administered I.V on weeks 2 and 3, day 1.
Cycle 2 (3 weeks, combination therapy):
Carboplatin (AUC=5) administered I.V week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1. 250 mg/m ² cetuximab administered I.V weeks 1- 3,day 1.
Group C:
Cycle 1 (4 weeks, combination therapy):
Carboplatin (AUC=5) administered I.V on week 1, day 1.1000 mg/m ²/day 5-FU administered as a 96-hour C.I. starting on week 1, day 1.
400 mg/m² cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3 and 4, day 1.
Cycle 2-6 (3 weeks, combination therapy):
Carboplatin (AUC=5) administered I.V on week1,day1.1000 mg/m ²/d 5-FU as a 96-hour C.I. starting on week1, day1. 250 mg/m ² cetuximab administered I.V on Week 1-3, day 1.
|
|---|---|---|
|
Cetuximab PK: Area Under the Concentration Versus Time Curve During One Dosing Interval at Steady State (AUC τ,ss)
|
17200 micrograms*hour/milliliters (μg•h/mL)
Geometric Coefficient of Variation 15.8
|
16700 micrograms*hour/milliliters (μg•h/mL)
Geometric Coefficient of Variation 18.5
|
PRIMARY outcome
Timeframe: Group D: Cycle 1, Week 1, Day 1; Prior to Carboplatin Infusion, 1hour (H), 1:30 H, 2 H, 3 H, 5 H, 8 H, 24 H, 72 H (after the Start of Carboplatin Infusion)Population: Participants who received at least 1 dose of study drug who were enrolled in Group(Grp)D \& had evaluable PK data.Study design by intent did not collect data from Grp B.Due to participant recruitment \& retention challenges,there were no PK study completers for Grp A \& C.Participant recruitment \& retention addressed by amending protocol to add Grp D.
Outcome measures
| Measure |
Cetuximab and Carboplatin (D)
n=13 Participants
Group D:
Cycle 1 (1 week, combination therapy):
400 milligrams per square meter (mg/m ²) cetuximab administered intravenously (I.V) on week 1, day 1. Carboplatin area under the curve (AUC=5) administered I.V on week 1, day 1.
Optional 5- fluorouracil (FU) administered as a 96-hour continuous infusion (C.I.) of 1000 mg/ m ²/day administered starting on week 1, day 1.
|
Cetuximab and Carboplatin (B and C)
Group B:
Cycle 1 (3 weeks, single-agent cetuximab):
400 mg/m² cetuximab administered I.V on week 1, day 1. 250 mg/m ² cetuximab administered I.V on weeks 2 and 3, day 1.
Cycle 2 (3 weeks, combination therapy):
Carboplatin (AUC=5) administered I.V week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1. 250 mg/m ² cetuximab administered I.V weeks 1- 3,day 1.
Group C:
Cycle 1 (4 weeks, combination therapy):
Carboplatin (AUC=5) administered I.V on week 1, day 1.1000 mg/m ²/day 5-FU administered as a 96-hour C.I. starting on week 1, day 1.
400 mg/m² cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3 and 4, day 1.
Cycle 2-6 (3 weeks, combination therapy):
Carboplatin (AUC=5) administered I.V on week1,day1.1000 mg/m ²/d 5-FU as a 96-hour C.I. starting on week1, day1. 250 mg/m ² cetuximab administered I.V on Week 1-3, day 1.
|
|---|---|---|
|
Total Carboplatin PK: Maximum Observed Plasma Concentration (Cmax)
|
11.5 micrograms per milliliters (μg/mL)
Geometric Coefficient of Variation 15.8
|
—
|
PRIMARY outcome
Timeframe: (Group B: Cycle 1 and Cycle 2+ ; Day 1, 8, 15 and Group C: Cycle 1, Day 8, 15 and 22; Cycle 2+, Day 1,8 and 15): Prior to Cetuximab Infusion, 1 Hour (H), 2 H, 4 H, 8 H, 24 H, 72 H, 120 H, and 168 H (after the start of Cetuximab Infusion)Population: All participants who received at least one dose of study drug who were enrolled in Group B and C and had evaluable PK data. Study design by intent did not collect data from Groups D and A.
Outcome measures
| Measure |
Cetuximab and Carboplatin (D)
n=5 Participants
Group D:
Cycle 1 (1 week, combination therapy):
400 milligrams per square meter (mg/m ²) cetuximab administered intravenously (I.V) on week 1, day 1. Carboplatin area under the curve (AUC=5) administered I.V on week 1, day 1.
Optional 5- fluorouracil (FU) administered as a 96-hour continuous infusion (C.I.) of 1000 mg/ m ²/day administered starting on week 1, day 1.
|
Cetuximab and Carboplatin (B and C)
n=5 Participants
Group B:
Cycle 1 (3 weeks, single-agent cetuximab):
400 mg/m² cetuximab administered I.V on week 1, day 1. 250 mg/m ² cetuximab administered I.V on weeks 2 and 3, day 1.
Cycle 2 (3 weeks, combination therapy):
Carboplatin (AUC=5) administered I.V week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1. 250 mg/m ² cetuximab administered I.V weeks 1- 3,day 1.
Group C:
Cycle 1 (4 weeks, combination therapy):
Carboplatin (AUC=5) administered I.V on week 1, day 1.1000 mg/m ²/day 5-FU administered as a 96-hour C.I. starting on week 1, day 1.
400 mg/m² cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3 and 4, day 1.
Cycle 2-6 (3 weeks, combination therapy):
Carboplatin (AUC=5) administered I.V on week1,day1.1000 mg/m ²/d 5-FU as a 96-hour C.I. starting on week1, day1. 250 mg/m ² cetuximab administered I.V on Week 1-3, day 1.
|
|---|---|---|
|
Cetuximab PK: Maximum Observed Plasma Concentration at Steady State (Cmax,ss)
|
199 micrograms per milliliters (μg/mL)
Geometric Coefficient of Variation 10.3
|
199 micrograms per milliliters (μg/mL)
Geometric Coefficient of Variation 10.8
|
PRIMARY outcome
Timeframe: Group D: Cycle 1, Week 1, Day 1; Prior to Carboplatin Infusion, 1hour (H), 1:30 H, 2 H, 3 H, 5 H, 8 H, 24 H, 72 H (after the Start of Carboplatin Infusion)Population: Participants who received at least 1 dose of study drug who were enrolled in Group(Grp)D \& had evaluable PK data.Study design by intent did not collect data from Grp B.Due to participant recruitment \& retention challenges,there were no PK study completers for Grp A \& C.Participant recruitment \& retention addressed by amending protocol to add Grp D.
Outcome measures
| Measure |
Cetuximab and Carboplatin (D)
n=13 Participants
Group D:
Cycle 1 (1 week, combination therapy):
400 milligrams per square meter (mg/m ²) cetuximab administered intravenously (I.V) on week 1, day 1. Carboplatin area under the curve (AUC=5) administered I.V on week 1, day 1.
Optional 5- fluorouracil (FU) administered as a 96-hour continuous infusion (C.I.) of 1000 mg/ m ²/day administered starting on week 1, day 1.
|
Cetuximab and Carboplatin (B and C)
Group B:
Cycle 1 (3 weeks, single-agent cetuximab):
400 mg/m² cetuximab administered I.V on week 1, day 1. 250 mg/m ² cetuximab administered I.V on weeks 2 and 3, day 1.
Cycle 2 (3 weeks, combination therapy):
Carboplatin (AUC=5) administered I.V week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1. 250 mg/m ² cetuximab administered I.V weeks 1- 3,day 1.
Group C:
Cycle 1 (4 weeks, combination therapy):
Carboplatin (AUC=5) administered I.V on week 1, day 1.1000 mg/m ²/day 5-FU administered as a 96-hour C.I. starting on week 1, day 1.
400 mg/m² cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3 and 4, day 1.
Cycle 2-6 (3 weeks, combination therapy):
Carboplatin (AUC=5) administered I.V on week1,day1.1000 mg/m ²/d 5-FU as a 96-hour C.I. starting on week1, day1. 250 mg/m ² cetuximab administered I.V on Week 1-3, day 1.
|
|---|---|---|
|
Total Carboplatin PK: Time of Maximum Observed Plasma Concentration (Tmax)
|
1.12 Hour (h)
Interval 1.0 to 1.3
|
—
|
PRIMARY outcome
Timeframe: (Group B: Cycle 1 and Cycle 2+ ; Day 1, 8, 15 and Group C: Cycle 1, Day 8, 15 and 22; Cycle 2+, Day 1,8 and 15): Prior to Cetuximab Infusion, 1 Hour (H), 2 H, 4 H, 8 H, 24 H, 72 H, 120 H, and 168 H (after the start of Cetuximab Infusion)Population: All participants who received at least one dose of study drug who were enrolled in Group B and C and had evaluable PK data. Study design by intent did not collect data from Groups D and A.
Outcome measures
| Measure |
Cetuximab and Carboplatin (D)
n=5 Participants
Group D:
Cycle 1 (1 week, combination therapy):
400 milligrams per square meter (mg/m ²) cetuximab administered intravenously (I.V) on week 1, day 1. Carboplatin area under the curve (AUC=5) administered I.V on week 1, day 1.
Optional 5- fluorouracil (FU) administered as a 96-hour continuous infusion (C.I.) of 1000 mg/ m ²/day administered starting on week 1, day 1.
|
Cetuximab and Carboplatin (B and C)
n=5 Participants
Group B:
Cycle 1 (3 weeks, single-agent cetuximab):
400 mg/m² cetuximab administered I.V on week 1, day 1. 250 mg/m ² cetuximab administered I.V on weeks 2 and 3, day 1.
Cycle 2 (3 weeks, combination therapy):
Carboplatin (AUC=5) administered I.V week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1. 250 mg/m ² cetuximab administered I.V weeks 1- 3,day 1.
Group C:
Cycle 1 (4 weeks, combination therapy):
Carboplatin (AUC=5) administered I.V on week 1, day 1.1000 mg/m ²/day 5-FU administered as a 96-hour C.I. starting on week 1, day 1.
400 mg/m² cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3 and 4, day 1.
Cycle 2-6 (3 weeks, combination therapy):
Carboplatin (AUC=5) administered I.V on week1,day1.1000 mg/m ²/d 5-FU as a 96-hour C.I. starting on week1, day1. 250 mg/m ² cetuximab administered I.V on Week 1-3, day 1.
|
|---|---|---|
|
Cetuximab PK: Time of Maximum Observed Plasma Concentration at Steady State (Tmax,ss)
|
1.15 Hour (h)
Interval 1.02 to 7.83
|
3.17 Hour (h)
Interval 2.0 to 4.07
|
PRIMARY outcome
Timeframe: Group D: Prior to Carboplatin Infusion, Cycle 1, Day 1Population: All participants who received at least one dose of study drug who were enrolled in Group D and had evaluable PK data. Study design by intent did not collect data from Groups A, B, and C.
Outcome measures
| Measure |
Cetuximab and Carboplatin (D)
n=14 Participants
Group D:
Cycle 1 (1 week, combination therapy):
400 milligrams per square meter (mg/m ²) cetuximab administered intravenously (I.V) on week 1, day 1. Carboplatin area under the curve (AUC=5) administered I.V on week 1, day 1.
Optional 5- fluorouracil (FU) administered as a 96-hour continuous infusion (C.I.) of 1000 mg/ m ²/day administered starting on week 1, day 1.
|
Cetuximab and Carboplatin (B and C)
Group B:
Cycle 1 (3 weeks, single-agent cetuximab):
400 mg/m² cetuximab administered I.V on week 1, day 1. 250 mg/m ² cetuximab administered I.V on weeks 2 and 3, day 1.
Cycle 2 (3 weeks, combination therapy):
Carboplatin (AUC=5) administered I.V week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1. 250 mg/m ² cetuximab administered I.V weeks 1- 3,day 1.
Group C:
Cycle 1 (4 weeks, combination therapy):
Carboplatin (AUC=5) administered I.V on week 1, day 1.1000 mg/m ²/day 5-FU administered as a 96-hour C.I. starting on week 1, day 1.
400 mg/m² cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3 and 4, day 1.
Cycle 2-6 (3 weeks, combination therapy):
Carboplatin (AUC=5) administered I.V on week1,day1.1000 mg/m ²/d 5-FU as a 96-hour C.I. starting on week1, day1. 250 mg/m ² cetuximab administered I.V on Week 1-3, day 1.
|
|---|---|---|
|
Cetuximab PK: Confirmatory Serum Concentration
|
195 micrograms per milliliters (µg/mL)
Geometric Coefficient of Variation 16.5
|
—
|
Adverse Events
Carboplatin and Cetuximab (A)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Carboplatin and Cetuximab (B)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Carboplatin and Cetuximab (C)
Serious events: 5 serious events
Other events: 14 other events
Deaths: 0 deaths
Carboplatin and Cetuximab (D)
Serious events: 10 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Carboplatin and Cetuximab (A)
n=2 participants at risk
Group A:
Cycle 1 (3 weeks, combination therapy):
Carboplatin (AUC=5) administered I.V on week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1.
400 mg/m ² cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3, day 1.
Cycle 2 (3 weeks, combination therapy):
Carboplatin (AUC=5) administered I.V on week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1. 250 mg/m ² cetuximab administered I.V on weeks 1- 3, day 1.
|
Carboplatin and Cetuximab (B)
n=3 participants at risk
Group B:
Cycle 1 (3 weeks, single-agent cetuximab):
400 mg/m² cetuximab administered I.V on week 1, day 1. 250 mg/m ² cetuximab administered I.V on weeks 2 and 3, day 1.
Cycle 2 (3 weeks, combination therapy):
Carboplatin (AUC=5) administered I.V week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1. 250 mg/m ² cetuximab administered I.V weeks 1- 3,day 1.
|
Carboplatin and Cetuximab (C)
n=14 participants at risk
Group C:
Cycle 1 (4 weeks, combination therapy):
Carboplatin (AUC=5) administered I.V on week 1, day 1.1000 mg/m ²/day 5-FU administered as a 96-hour C.I. starting on week 1, day 1.
400 mg/m² cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3 and 4, day1.
Cycle 2-6 (3 weeks, combination therapy):
Carboplatin (AUC=5) administered I.V on week1,day1.1000 mg/m ²/d 5-FU as a 96-hour C.I. starting on week1, day1. 250 mg/m ² cetuximab administered I.V on Week 1-3, day 1.
|
Carboplatin and Cetuximab (D)
n=15 participants at risk
Group D:
Cycle 1 (1 week, combination therapy):
400 milligrams per square meter (mg/m ²) cetuximab administered intravenously (I.V) on day 1. Carboplatin area under the curve (AUC=5) administered I.V on day 1.
Optional 5- fluorouracil (FU) administered as a 96-hour continuous infusion (C.I.) of 1000 mg/ m ²/day administered starting on day 1.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 1
|
0.00%
0/15
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 1
|
0.00%
0/15
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 1
|
0.00%
0/15
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 1
|
0.00%
0/15
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 1
|
6.7%
1/15 • Number of events 1
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 1
|
0.00%
0/15
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
General disorders
Non-cardiac chest pain
|
50.0%
1/2 • Number of events 1
|
0.00%
0/3
|
0.00%
0/14
|
0.00%
0/15
|
|
General disorders
Pyrexia
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Infections and infestations
Sepsis
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
13.3%
2/15 • Number of events 2
|
|
Injury, poisoning and procedural complications
Foreign body
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 1
|
0.00%
0/15
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/2
|
33.3%
1/3 • Number of events 1
|
0.00%
0/14
|
0.00%
0/15
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 1
|
0.00%
0/15
|
|
Nervous system disorders
Lethargy
|
0.00%
0/2
|
33.3%
1/3 • Number of events 1
|
0.00%
0/14
|
0.00%
0/15
|
|
Nervous system disorders
Seizure
|
50.0%
1/2 • Number of events 1
|
0.00%
0/3
|
0.00%
0/14
|
0.00%
0/15
|
|
Renal and urinary disorders
Haematuria
|
50.0%
1/2 • Number of events 1
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Renal and urinary disorders
Obstructive uropathy
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 1
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
50.0%
1/2 • Number of events 1
|
0.00%
0/3
|
0.00%
0/14
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal haematoma
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 1
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 1
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
Other adverse events
| Measure |
Carboplatin and Cetuximab (A)
n=2 participants at risk
Group A:
Cycle 1 (3 weeks, combination therapy):
Carboplatin (AUC=5) administered I.V on week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1.
400 mg/m ² cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3, day 1.
Cycle 2 (3 weeks, combination therapy):
Carboplatin (AUC=5) administered I.V on week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1. 250 mg/m ² cetuximab administered I.V on weeks 1- 3, day 1.
|
Carboplatin and Cetuximab (B)
n=3 participants at risk
Group B:
Cycle 1 (3 weeks, single-agent cetuximab):
400 mg/m² cetuximab administered I.V on week 1, day 1. 250 mg/m ² cetuximab administered I.V on weeks 2 and 3, day 1.
Cycle 2 (3 weeks, combination therapy):
Carboplatin (AUC=5) administered I.V week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1. 250 mg/m ² cetuximab administered I.V weeks 1- 3,day 1.
|
Carboplatin and Cetuximab (C)
n=14 participants at risk
Group C:
Cycle 1 (4 weeks, combination therapy):
Carboplatin (AUC=5) administered I.V on week 1, day 1.1000 mg/m ²/day 5-FU administered as a 96-hour C.I. starting on week 1, day 1.
400 mg/m² cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3 and 4, day1.
Cycle 2-6 (3 weeks, combination therapy):
Carboplatin (AUC=5) administered I.V on week1,day1.1000 mg/m ²/d 5-FU as a 96-hour C.I. starting on week1, day1. 250 mg/m ² cetuximab administered I.V on Week 1-3, day 1.
|
Carboplatin and Cetuximab (D)
n=15 participants at risk
Group D:
Cycle 1 (1 week, combination therapy):
400 milligrams per square meter (mg/m ²) cetuximab administered intravenously (I.V) on day 1. Carboplatin area under the curve (AUC=5) administered I.V on day 1.
Optional 5- fluorouracil (FU) administered as a 96-hour continuous infusion (C.I.) of 1000 mg/ m ²/day administered starting on day 1.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
50.0%
1/2 • Number of events 2
|
0.00%
0/3
|
28.6%
4/14 • Number of events 6
|
40.0%
6/15 • Number of events 15
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/2
|
0.00%
0/3
|
14.3%
2/14 • Number of events 2
|
0.00%
0/15
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 1
|
6.7%
1/15 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/2
|
0.00%
0/3
|
14.3%
2/14 • Number of events 8
|
13.3%
2/15 • Number of events 2
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/2
|
0.00%
0/3
|
21.4%
3/14 • Number of events 9
|
20.0%
3/15 • Number of events 5
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 1
|
0.00%
0/15
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 1
|
0.00%
0/15
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 1
|
0.00%
0/15
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
13.3%
2/15 • Number of events 2
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 1
|
0.00%
0/15
|
|
Ear and labyrinth disorders
Hyperacusis
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/2
|
33.3%
1/3 • Number of events 1
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Eye disorders
Eye discharge
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Eye disorders
Eye pain
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 1
|
0.00%
0/15
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Eye disorders
Photophobia
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
13.3%
2/15 • Number of events 2
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Eye disorders
Vision blurred
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 1
|
0.00%
0/15
|
|
Eye disorders
Visual impairment
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 1
|
0.00%
0/15
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/2
|
0.00%
0/3
|
14.3%
2/14 • Number of events 3
|
20.0%
3/15 • Number of events 3
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
50.0%
1/2 • Number of events 1
|
33.3%
1/3 • Number of events 3
|
35.7%
5/14 • Number of events 5
|
13.3%
2/15 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
1/2 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
57.1%
8/14 • Number of events 14
|
20.0%
3/15 • Number of events 3
|
|
Gastrointestinal disorders
Dry mouth
|
50.0%
1/2 • Number of events 1
|
0.00%
0/3
|
7.1%
1/14 • Number of events 1
|
0.00%
0/15
|
|
Gastrointestinal disorders
Dysphagia
|
50.0%
1/2 • Number of events 1
|
0.00%
0/3
|
50.0%
7/14 • Number of events 9
|
0.00%
0/15
|
|
Gastrointestinal disorders
Faeces soft
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 1
|
0.00%
0/15
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/2
|
0.00%
0/3
|
14.3%
2/14 • Number of events 2
|
6.7%
1/15 • Number of events 1
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 2
|
0.00%
0/15
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 1
|
6.7%
1/15 • Number of events 1
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 2
|
0.00%
0/15
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2
|
33.3%
1/3 • Number of events 4
|
78.6%
11/14 • Number of events 25
|
53.3%
8/15 • Number of events 10
|
|
Gastrointestinal disorders
Salivary gland disorder
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 1
|
0.00%
0/15
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/2
|
66.7%
2/3 • Number of events 2
|
35.7%
5/14 • Number of events 8
|
26.7%
4/15 • Number of events 5
|
|
Gastrointestinal disorders
Tongue haemorrhage
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2
|
66.7%
2/3 • Number of events 11
|
42.9%
6/14 • Number of events 14
|
33.3%
5/15 • Number of events 5
|
|
General disorders
Asthenia
|
50.0%
1/2 • Number of events 1
|
0.00%
0/3
|
28.6%
4/14 • Number of events 6
|
6.7%
1/15 • Number of events 1
|
|
General disorders
Catheter site bruise
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 1
|
0.00%
0/15
|
|
General disorders
Catheter site pain
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 1
|
0.00%
0/15
|
|
General disorders
Catheter site rash
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 1
|
0.00%
0/15
|
|
General disorders
Chest pain
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 1
|
0.00%
0/15
|
|
General disorders
Decreased activity
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
General disorders
Face oedema
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 1
|
0.00%
0/15
|
|
General disorders
Fatigue
|
50.0%
1/2 • Number of events 1
|
66.7%
2/3 • Number of events 9
|
50.0%
7/14 • Number of events 10
|
60.0%
9/15 • Number of events 11
|
|
General disorders
Infusion site rash
|
0.00%
0/2
|
33.3%
1/3 • Number of events 1
|
0.00%
0/14
|
0.00%
0/15
|
|
General disorders
Local swelling
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 1
|
0.00%
0/15
|
|
General disorders
Malaise
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
General disorders
Mucosal inflammation
|
50.0%
1/2 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
50.0%
7/14 • Number of events 23
|
20.0%
3/15 • Number of events 4
|
|
General disorders
Oedema peripheral
|
0.00%
0/2
|
0.00%
0/3
|
21.4%
3/14 • Number of events 4
|
13.3%
2/15 • Number of events 2
|
|
General disorders
Pain
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 1
|
0.00%
0/15
|
|
General disorders
Peripheral swelling
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
General disorders
Pyrexia
|
0.00%
0/2
|
33.3%
1/3 • Number of events 2
|
7.1%
1/14 • Number of events 1
|
6.7%
1/15 • Number of events 1
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Infections and infestations
Candida infection
|
0.00%
0/2
|
0.00%
0/3
|
14.3%
2/14 • Number of events 2
|
0.00%
0/15
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Infections and infestations
Folliculitis
|
0.00%
0/2
|
33.3%
1/3 • Number of events 2
|
0.00%
0/14
|
0.00%
0/15
|
|
Infections and infestations
Infection
|
0.00%
0/2
|
33.3%
1/3 • Number of events 1
|
0.00%
0/14
|
0.00%
0/15
|
|
Infections and infestations
Nail infection
|
0.00%
0/2
|
33.3%
1/3 • Number of events 1
|
0.00%
0/14
|
0.00%
0/15
|
|
Infections and infestations
Opportunistic infection
|
0.00%
0/2
|
33.3%
1/3 • Number of events 3
|
0.00%
0/14
|
0.00%
0/15
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
13.3%
2/15 • Number of events 3
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 1
|
0.00%
0/15
|
|
Infections and infestations
Rash pustular
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 1
|
6.7%
1/15 • Number of events 1
|
|
Infections and infestations
Skin infection
|
0.00%
0/2
|
33.3%
1/3 • Number of events 3
|
0.00%
0/14
|
0.00%
0/15
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/2
|
33.3%
1/3 • Number of events 1
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Infections and infestations
Wound infection
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 1
|
0.00%
0/15
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 1
|
0.00%
0/15
|
|
Injury, poisoning and procedural complications
Feeding tube complication
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 1
|
0.00%
0/15
|
|
Injury, poisoning and procedural complications
Human bite
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 1
|
0.00%
0/15
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
0.00%
0/2
|
33.3%
1/3 • Number of events 1
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 2
|
0.00%
0/15
|
|
Investigations
Alanine aminotransferase decreased
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
13.3%
2/15 • Number of events 2
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 2
|
6.7%
1/15 • Number of events 1
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Investigations
Blood creatinine increased
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
13.3%
2/15 • Number of events 2
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Investigations
Breath sounds abnormal
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Investigations
Electrocardiogram qt prolonged
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/2
|
66.7%
2/3 • Number of events 6
|
0.00%
0/14
|
0.00%
0/15
|
|
Investigations
International normalised ratio increased
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Investigations
Monocyte count increased
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/2
|
33.3%
1/3 • Number of events 2
|
14.3%
2/14 • Number of events 2
|
6.7%
1/15 • Number of events 3
|
|
Investigations
Platelet count decreased
|
50.0%
1/2 • Number of events 4
|
33.3%
1/3 • Number of events 3
|
21.4%
3/14 • Number of events 4
|
40.0%
6/15 • Number of events 20
|
|
Investigations
Weight decreased
|
0.00%
0/2
|
33.3%
1/3 • Number of events 2
|
7.1%
1/14 • Number of events 1
|
6.7%
1/15 • Number of events 1
|
|
Investigations
White blood cell count decreased
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 1
|
0.00%
0/15
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/2
|
0.00%
0/3
|
35.7%
5/14 • Number of events 11
|
33.3%
5/15 • Number of events 6
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/2
|
33.3%
1/3 • Number of events 1
|
28.6%
4/14 • Number of events 7
|
13.3%
2/15 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 1
|
6.7%
1/15 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/2
|
33.3%
1/3 • Number of events 1
|
21.4%
3/14 • Number of events 3
|
60.0%
9/15 • Number of events 13
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/2
|
0.00%
0/3
|
28.6%
4/14 • Number of events 9
|
40.0%
6/15 • Number of events 11
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/2
|
33.3%
1/3 • Number of events 1
|
14.3%
2/14 • Number of events 3
|
20.0%
3/15 • Number of events 7
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Metabolism and nutrition disorders
Magnesium deficiency
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 1
|
0.00%
0/15
|
|
Metabolism and nutrition disorders
Vitamin d deficiency
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/2
|
33.3%
1/3 • Number of events 1
|
14.3%
2/14 • Number of events 2
|
6.7%
1/15 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 1
|
0.00%
0/15
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 1
|
0.00%
0/15
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 1
|
0.00%
0/15
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 1
|
0.00%
0/15
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/2
|
0.00%
0/3
|
14.3%
2/14 • Number of events 2
|
0.00%
0/15
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 2
|
0.00%
0/15
|
|
Nervous system disorders
Ataxia
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 2
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2
|
0.00%
0/3
|
14.3%
2/14 • Number of events 2
|
0.00%
0/15
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/2
|
0.00%
0/3
|
21.4%
3/14 • Number of events 5
|
6.7%
1/15 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.00%
0/2
|
0.00%
0/3
|
14.3%
2/14 • Number of events 3
|
20.0%
3/15 • Number of events 4
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Nervous system disorders
Muscle tone disorder
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 1
|
0.00%
0/15
|
|
Nervous system disorders
Neuropathy peripheral
|
50.0%
1/2 • Number of events 1
|
0.00%
0/3
|
14.3%
2/14 • Number of events 2
|
0.00%
0/15
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 2
|
|
Nervous system disorders
Reflexes abnormal
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Nervous system disorders
Syncope
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 1
|
0.00%
0/15
|
|
Nervous system disorders
Tremor
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 3
|
0.00%
0/15
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 1
|
13.3%
2/15 • Number of events 2
|
|
Psychiatric disorders
Depression
|
0.00%
0/2
|
0.00%
0/3
|
14.3%
2/14 • Number of events 3
|
0.00%
0/15
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/2
|
0.00%
0/3
|
28.6%
4/14 • Number of events 5
|
6.7%
1/15 • Number of events 1
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 1
|
0.00%
0/15
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 1
|
0.00%
0/15
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 1
|
6.7%
1/15 • Number of events 1
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/2
|
33.3%
1/3 • Number of events 2
|
0.00%
0/14
|
0.00%
0/15
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
25.0%
1/4 • Number of events 1
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
25.0%
1/4 • Number of events 1
|
|
Reproductive system and breast disorders
Vulvovaginal pain
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
25.0%
1/4 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/2
|
33.3%
1/3 • Number of events 1
|
14.3%
2/14 • Number of events 5
|
13.3%
2/15 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 1
|
26.7%
4/15 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/2
|
0.00%
0/3
|
14.3%
2/14 • Number of events 2
|
13.3%
2/15 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 2
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 1
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/2
|
33.3%
1/3 • Number of events 1
|
28.6%
4/14 • Number of events 4
|
6.7%
1/15 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 2
|
6.7%
1/15 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 1
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/2
|
0.00%
0/3
|
35.7%
5/14 • Number of events 5
|
0.00%
0/15
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
50.0%
1/2 • Number of events 1
|
0.00%
0/3
|
50.0%
7/14 • Number of events 15
|
60.0%
9/15 • Number of events 14
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/2
|
0.00%
0/3
|
21.4%
3/14 • Number of events 3
|
0.00%
0/15
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
0.00%
0/2
|
33.3%
1/3 • Number of events 1
|
0.00%
0/14
|
0.00%
0/15
|
|
Skin and subcutaneous tissue disorders
Hirsutism
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
25.0%
1/4 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 1
|
0.00%
0/15
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 1
|
0.00%
0/15
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 1
|
0.00%
0/15
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/2
|
0.00%
0/3
|
28.6%
4/14 • Number of events 11
|
6.7%
1/15 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 1
|
0.00%
0/15
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/2
|
0.00%
0/3
|
35.7%
5/14 • Number of events 6
|
0.00%
0/15
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 1
|
6.7%
1/15 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 1
|
0.00%
0/15
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 1
|
6.7%
1/15 • Number of events 1
|
|
Vascular disorders
Flushing
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Vascular disorders
Hypotension
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 3
|
0.00%
0/15
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/2
|
0.00%
0/3
|
14.3%
2/14 • Number of events 2
|
0.00%
0/15
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/2
|
0.00%
0/3
|
7.1%
1/14 • Number of events 1
|
0.00%
0/15
|
|
Vascular disorders
Pallor
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
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