Trial Outcomes & Findings for Phase III Trial to Assess Efficacy and Safety of Cetuximab for the Treatment of Chinese Participants With Head and Neck Cancer (NCT NCT02383966)
NCT ID: NCT02383966
Last Updated: 2022-05-13
Results Overview
PFS time was defined as the time in months from the date of randomization until first observation of PD (based on imaging as assessed by IRC), or death due to any cause when death occurs within 60 days after the last tumor assessment or randomization (whichever is later). PD is defined as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on trial; and/or unequivocal progression of existing non-target lesions and/or the presence of new lesions. The sum must also demonstrate an absolute increase of at least 5 millimeter. PFS was measured using Kaplan-Meier (KM) estimates.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
243 participants
Primary outcome timeframe
Every 6 weeks starting from the date of randomization until occurrence of PD, assessed up to data-cutoff (904 days)
Results posted on
2022-05-13
Participant Flow
First participant signed informed consent: 31 Jul 2015, Clinical data cut-off: 19 Jan 2018.
Participant milestones
| Measure |
Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil
Participants received Cetuximab as an intravenous infusion at an initial dose of 400 milligrams per square meter (mg/m\^2) on Day 1 and a subsequent dose of 250 mg/m\^2 on Day 8 and Day 15 of each 21-day treatment cycle. Cisplatin or Carboplatin (at an equivalent dose in case of intolerability of cisplatin) was administered at a dose of 75 mg/m\^2 as an intravenous infusion on Day 1 of each 21-day treatment cycle. After the administration of cisplatin or carboplatin, participants received 5-fluorouracil (5-FU) at a dose of 750 mg/m\^2/day as a continuous intravenous infusion over 24 hours a day from Day 1 to Day 5 of each 21-day treatment cycle. All treatments were administered up to a maximum of 6 treatment cycles, post this participants without progressive disease (PD) continued to receive monotherapy with cetuximab until occurrence of disease progression or unacceptable toxicity.
|
Cisplatin/Carboplatin + 5-Flurouracil
Participants received cisplatin or carboplatin (at an equivalent dose in case of intolerability of cisplatin) was administered at a dose of 75 mg/m\^2 as an intravenous infusion on Day 1 of each 21-day treatment cycle. After the administration of cisplatin or carboplatin, participants received 5-fluorouracil (FU) at a dose of 750 mg/m\^2/day as a continuous intravenous infusion over 24 hours a day from Day 1 to Day 5 of each 21-day treatment cycle. All treatments were administered up to a maximum of 6 treatment cycles.
|
|---|---|---|
|
Overall Study
STARTED
|
164
|
79
|
|
Overall Study
COMPLETED
|
138
|
72
|
|
Overall Study
NOT COMPLETED
|
26
|
7
|
Reasons for withdrawal
| Measure |
Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil
Participants received Cetuximab as an intravenous infusion at an initial dose of 400 milligrams per square meter (mg/m\^2) on Day 1 and a subsequent dose of 250 mg/m\^2 on Day 8 and Day 15 of each 21-day treatment cycle. Cisplatin or Carboplatin (at an equivalent dose in case of intolerability of cisplatin) was administered at a dose of 75 mg/m\^2 as an intravenous infusion on Day 1 of each 21-day treatment cycle. After the administration of cisplatin or carboplatin, participants received 5-fluorouracil (5-FU) at a dose of 750 mg/m\^2/day as a continuous intravenous infusion over 24 hours a day from Day 1 to Day 5 of each 21-day treatment cycle. All treatments were administered up to a maximum of 6 treatment cycles, post this participants without progressive disease (PD) continued to receive monotherapy with cetuximab until occurrence of disease progression or unacceptable toxicity.
|
Cisplatin/Carboplatin + 5-Flurouracil
Participants received cisplatin or carboplatin (at an equivalent dose in case of intolerability of cisplatin) was administered at a dose of 75 mg/m\^2 as an intravenous infusion on Day 1 of each 21-day treatment cycle. After the administration of cisplatin or carboplatin, participants received 5-fluorouracil (FU) at a dose of 750 mg/m\^2/day as a continuous intravenous infusion over 24 hours a day from Day 1 to Day 5 of each 21-day treatment cycle. All treatments were administered up to a maximum of 6 treatment cycles.
|
|---|---|---|
|
Overall Study
Ongoing at clinical cut-off date
|
25
|
4
|
|
Overall Study
Randomized, but not treated
|
1
|
3
|
Baseline Characteristics
Phase III Trial to Assess Efficacy and Safety of Cetuximab for the Treatment of Chinese Participants With Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil
n=164 Participants
Participants received Cetuximab as an intravenous infusion at an initial dose of 400 milligrams per square meter (mg/m\^2) on Day 1 and a subsequent dose of 250 mg/m\^2 on Day 8 and Day 15 of each 21-day treatment cycle. Cisplatin or Carboplatin (at an equivalent dose in case of intolerability of cisplatin) was administered at a dose of 75 mg/m\^2 as an intravenous infusion on Day 1 of each 21-day treatment cycle. After the administration of cisplatin or carboplatin, participants received 5-fluorouracil (5-FU) at a dose of 750 mg/m\^2/day as a continuous intravenous infusion over 24 hours a day from Day 1 to Day 5 of each 21-day treatment cycle. All treatments were administered up to a maximum of 6 treatment cycles, post this participants without progressive disease (PD) continued to receive monotherapy with cetuximab until occurrence of disease progression or unacceptable toxicity.
|
Cisplatin/Carboplatin + 5-Flurouracil
n=79 Participants
Participants received cisplatin or carboplatin (at an equivalent dose in case of intolerability of cisplatin) was administered at a dose of 75 mg/m\^2 as an intravenous infusion on Day 1 of each 21-day treatment cycle. After the administration of cisplatin or carboplatin, participants received 5-fluorouracil (FU) at a dose of 750 mg/m\^2/day as a continuous intravenous infusion over 24 hours a day from Day 1 to Day 5 of each 21-day treatment cycle. All treatments were administered up to a maximum of 6 treatment cycles.
|
Total
n=243 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.1 years
STANDARD_DEVIATION 9.52 • n=5 Participants
|
57.0 years
STANDARD_DEVIATION 8.99 • n=7 Participants
|
57.1 years
STANDARD_DEVIATION 9.34 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
146 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
213 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
164 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
243 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
|
164 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
243 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
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
PRIMARY outcome
Timeframe: Every 6 weeks starting from the date of randomization until occurrence of PD, assessed up to data-cutoff (904 days)Population: ITT analysis set included all participants who were randomized to study treatment.
PFS time was defined as the time in months from the date of randomization until first observation of PD (based on imaging as assessed by IRC), or death due to any cause when death occurs within 60 days after the last tumor assessment or randomization (whichever is later). PD is defined as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on trial; and/or unequivocal progression of existing non-target lesions and/or the presence of new lesions. The sum must also demonstrate an absolute increase of at least 5 millimeter. PFS was measured using Kaplan-Meier (KM) estimates.
Outcome measures
| Measure |
Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil
n=164 Participants
Participants received Cetuximab as an intravenous infusion at an initial dose of 400 milligrams per square meter (mg/m\^2) on Day 1 and a subsequent dose of 250 mg/m\^2 on Day 8 and Day 15 of each 21-day treatment cycle. Cisplatin or Carboplatin (at an equivalent dose in case of intolerability of cisplatin) was administered at a dose of 75 mg/m\^2 as an intravenous infusion on Day 1 of each 21-day treatment cycle. After the administration of cisplatin or carboplatin, participants received 5-fluorouracil (5-FU) at a dose of 750 mg/m\^2/day as a continuous intravenous infusion over 24 hours a day from Day 1 to Day 5 of each 21-day treatment cycle. All treatments were administered up to a maximum of 6 treatment cycles, post this participants without progressive disease (PD) continued to receive monotherapy with cetuximab until occurrence of disease progression or unacceptable toxicity.
|
Cisplatin/Carboplatin + 5-Flurouracil
n=79 Participants
Participants received cisplatin or carboplatin (at an equivalent dose in case of intolerability of cisplatin) was administered at a dose of 75 mg/m\^2 as an intravenous infusion on Day 1 of each 21-day treatment cycle. After the administration of cisplatin or carboplatin, participants received 5-fluorouracil (FU) at a dose of 750 mg/m\^2/day as a continuous intravenous infusion over 24 hours a day from Day 1 to Day 5 of each 21-day treatment cycle. All treatments were administered up to a maximum of 6 treatment cycles.
|
|---|---|---|
|
Progression-free Survival (PFS) Time, as Assessed by an Independent Review Committee (IRC)
|
5.5 months
Interval 5.4 to 5.6
|
4.2 months
Interval 3.0 to 5.3
|
SECONDARY outcome
Timeframe: Every 6 weeks starting from the date of randomization until occurrence of PD, assessed up to data-cutoff (904 days)Population: ITT analysis set included all participants who were randomized to study treatment.
PFS time was defined as the time in months from the date of randomization until first observation of PD (radiologically confirmed by Investigator), or death due to any cause when death occurs within 60 days after the last tumor assessment or randomization (whichever is later). PD is defined as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on trial; and/or unequivocal progression of existing non-target lesions and/or the presence of new lesions. The sum must also demonstrate an absolute increase of at least 5 millimeter. PFS was measured using Kaplan-Meier (KM) estimates.
Outcome measures
| Measure |
Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil
n=164 Participants
Participants received Cetuximab as an intravenous infusion at an initial dose of 400 milligrams per square meter (mg/m\^2) on Day 1 and a subsequent dose of 250 mg/m\^2 on Day 8 and Day 15 of each 21-day treatment cycle. Cisplatin or Carboplatin (at an equivalent dose in case of intolerability of cisplatin) was administered at a dose of 75 mg/m\^2 as an intravenous infusion on Day 1 of each 21-day treatment cycle. After the administration of cisplatin or carboplatin, participants received 5-fluorouracil (5-FU) at a dose of 750 mg/m\^2/day as a continuous intravenous infusion over 24 hours a day from Day 1 to Day 5 of each 21-day treatment cycle. All treatments were administered up to a maximum of 6 treatment cycles, post this participants without progressive disease (PD) continued to receive monotherapy with cetuximab until occurrence of disease progression or unacceptable toxicity.
|
Cisplatin/Carboplatin + 5-Flurouracil
n=79 Participants
Participants received cisplatin or carboplatin (at an equivalent dose in case of intolerability of cisplatin) was administered at a dose of 75 mg/m\^2 as an intravenous infusion on Day 1 of each 21-day treatment cycle. After the administration of cisplatin or carboplatin, participants received 5-fluorouracil (FU) at a dose of 750 mg/m\^2/day as a continuous intravenous infusion over 24 hours a day from Day 1 to Day 5 of each 21-day treatment cycle. All treatments were administered up to a maximum of 6 treatment cycles.
|
|---|---|---|
|
Progression-free Survival (PFS) Time, as Assessed by the Investigator
|
5.5 months
Interval 5.5 to 5.7
|
4.6 months
Interval 2.9 to 5.5
|
SECONDARY outcome
Timeframe: Time from date of randomization up to data cutoff (assessed up to 904 days)Population: ITT analysis set included all participants who were randomized to study treatment.
The OS time was defined as the time from randomization to the date of death. If a participant was alive at the time of analysis, survival time was censored at the last date when the participant was known to be alive. If this date was after data cut-off, participants were censored at the date of data cut-off. OS was measured using Kaplan-Meier (KM) estimates.
Outcome measures
| Measure |
Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil
n=164 Participants
Participants received Cetuximab as an intravenous infusion at an initial dose of 400 milligrams per square meter (mg/m\^2) on Day 1 and a subsequent dose of 250 mg/m\^2 on Day 8 and Day 15 of each 21-day treatment cycle. Cisplatin or Carboplatin (at an equivalent dose in case of intolerability of cisplatin) was administered at a dose of 75 mg/m\^2 as an intravenous infusion on Day 1 of each 21-day treatment cycle. After the administration of cisplatin or carboplatin, participants received 5-fluorouracil (5-FU) at a dose of 750 mg/m\^2/day as a continuous intravenous infusion over 24 hours a day from Day 1 to Day 5 of each 21-day treatment cycle. All treatments were administered up to a maximum of 6 treatment cycles, post this participants without progressive disease (PD) continued to receive monotherapy with cetuximab until occurrence of disease progression or unacceptable toxicity.
|
Cisplatin/Carboplatin + 5-Flurouracil
n=79 Participants
Participants received cisplatin or carboplatin (at an equivalent dose in case of intolerability of cisplatin) was administered at a dose of 75 mg/m\^2 as an intravenous infusion on Day 1 of each 21-day treatment cycle. After the administration of cisplatin or carboplatin, participants received 5-fluorouracil (FU) at a dose of 750 mg/m\^2/day as a continuous intravenous infusion over 24 hours a day from Day 1 to Day 5 of each 21-day treatment cycle. All treatments were administered up to a maximum of 6 treatment cycles.
|
|---|---|---|
|
Overall Survival (OS) Time
|
10.2 months
Interval 9.3 to 11.5
|
8.4 months
Interval 6.5 to 9.9
|
SECONDARY outcome
Timeframe: Every 6 weeks starting from the date of randomization until occurrence of PD, assessed up to data-cutoff (904 days)Population: ITT analysis set included all participants who were randomized to study treatment.
The Best ORR was based on imaging and classified according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria. The BOR rate was defined as the number of participants whose BOR was either complete response (CR) or partial response (PR), relative to the number of participants belonging to the trial set of interest. CR was defined as disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must had reduction in short axis to less than (\<) 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil
n=164 Participants
Participants received Cetuximab as an intravenous infusion at an initial dose of 400 milligrams per square meter (mg/m\^2) on Day 1 and a subsequent dose of 250 mg/m\^2 on Day 8 and Day 15 of each 21-day treatment cycle. Cisplatin or Carboplatin (at an equivalent dose in case of intolerability of cisplatin) was administered at a dose of 75 mg/m\^2 as an intravenous infusion on Day 1 of each 21-day treatment cycle. After the administration of cisplatin or carboplatin, participants received 5-fluorouracil (5-FU) at a dose of 750 mg/m\^2/day as a continuous intravenous infusion over 24 hours a day from Day 1 to Day 5 of each 21-day treatment cycle. All treatments were administered up to a maximum of 6 treatment cycles, post this participants without progressive disease (PD) continued to receive monotherapy with cetuximab until occurrence of disease progression or unacceptable toxicity.
|
Cisplatin/Carboplatin + 5-Flurouracil
n=79 Participants
Participants received cisplatin or carboplatin (at an equivalent dose in case of intolerability of cisplatin) was administered at a dose of 75 mg/m\^2 as an intravenous infusion on Day 1 of each 21-day treatment cycle. After the administration of cisplatin or carboplatin, participants received 5-fluorouracil (FU) at a dose of 750 mg/m\^2/day as a continuous intravenous infusion over 24 hours a day from Day 1 to Day 5 of each 21-day treatment cycle. All treatments were administered up to a maximum of 6 treatment cycles.
|
|---|---|---|
|
Best Overall Response Rate (ORR)
|
50 percentage of participants
Interval 42.1 to 57.9
|
26.6 percentage of participants
Interval 17.3 to 37.7
|
SECONDARY outcome
Timeframe: Every 6 weeks starting from the date of randomization until occurrence of PD, assessed up to data-cutoff (904 days)Population: ITT analysis set included all participants who were randomized to study treatment.
The DCR was based on imaging and classified according to RECIST Version 1.1 criteria. The DCR was defined as the number of participants whose Best Overall Response is either CR, PR or stable disease (SD), divided by the number of participants belonging to the trial set of interest multiplied by 100. CR was defined as disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must had reduction in short axis to less than (\<) 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on trial.
Outcome measures
| Measure |
Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil
n=164 Participants
Participants received Cetuximab as an intravenous infusion at an initial dose of 400 milligrams per square meter (mg/m\^2) on Day 1 and a subsequent dose of 250 mg/m\^2 on Day 8 and Day 15 of each 21-day treatment cycle. Cisplatin or Carboplatin (at an equivalent dose in case of intolerability of cisplatin) was administered at a dose of 75 mg/m\^2 as an intravenous infusion on Day 1 of each 21-day treatment cycle. After the administration of cisplatin or carboplatin, participants received 5-fluorouracil (5-FU) at a dose of 750 mg/m\^2/day as a continuous intravenous infusion over 24 hours a day from Day 1 to Day 5 of each 21-day treatment cycle. All treatments were administered up to a maximum of 6 treatment cycles, post this participants without progressive disease (PD) continued to receive monotherapy with cetuximab until occurrence of disease progression or unacceptable toxicity.
|
Cisplatin/Carboplatin + 5-Flurouracil
n=79 Participants
Participants received cisplatin or carboplatin (at an equivalent dose in case of intolerability of cisplatin) was administered at a dose of 75 mg/m\^2 as an intravenous infusion on Day 1 of each 21-day treatment cycle. After the administration of cisplatin or carboplatin, participants received 5-fluorouracil (FU) at a dose of 750 mg/m\^2/day as a continuous intravenous infusion over 24 hours a day from Day 1 to Day 5 of each 21-day treatment cycle. All treatments were administered up to a maximum of 6 treatment cycles.
|
|---|---|---|
|
Disease Control Rate (DCR)
|
75.6 percentage of participants
Interval 68.3 to 82.0
|
59.5 percentage of participants
Interval 47.9 to 70.4
|
SECONDARY outcome
Timeframe: Every 6 weeks starting from the date of randomization until occurrence of PD, assessed up to data-cutoff (904 days)Population: ITT analysis set included all participants who were randomized to study treatment.
DOR was determined for participants whose BOR was either CR or PR. It was defined as the time from the first assessment of CR or PR until the event defining PFS time. PFS time was defined as the time in months from the date of randomization until first observation of PD (based on imaging as assessed by IRC), or death due to any cause when death occurs within 60 days after the last tumor assessment or randomization (whichever is later). CR was defined as disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must had reduction in short axis to less than (\<) 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil
n=164 Participants
Participants received Cetuximab as an intravenous infusion at an initial dose of 400 milligrams per square meter (mg/m\^2) on Day 1 and a subsequent dose of 250 mg/m\^2 on Day 8 and Day 15 of each 21-day treatment cycle. Cisplatin or Carboplatin (at an equivalent dose in case of intolerability of cisplatin) was administered at a dose of 75 mg/m\^2 as an intravenous infusion on Day 1 of each 21-day treatment cycle. After the administration of cisplatin or carboplatin, participants received 5-fluorouracil (5-FU) at a dose of 750 mg/m\^2/day as a continuous intravenous infusion over 24 hours a day from Day 1 to Day 5 of each 21-day treatment cycle. All treatments were administered up to a maximum of 6 treatment cycles, post this participants without progressive disease (PD) continued to receive monotherapy with cetuximab until occurrence of disease progression or unacceptable toxicity.
|
Cisplatin/Carboplatin + 5-Flurouracil
n=79 Participants
Participants received cisplatin or carboplatin (at an equivalent dose in case of intolerability of cisplatin) was administered at a dose of 75 mg/m\^2 as an intravenous infusion on Day 1 of each 21-day treatment cycle. After the administration of cisplatin or carboplatin, participants received 5-fluorouracil (FU) at a dose of 750 mg/m\^2/day as a continuous intravenous infusion over 24 hours a day from Day 1 to Day 5 of each 21-day treatment cycle. All treatments were administered up to a maximum of 6 treatment cycles.
|
|---|---|---|
|
Duration of Response (DOR)
|
18.1 Weeks
Interval 13.1 to 20.3
|
13.9 Weeks
Interval 8.7 to 18.1
|
SECONDARY outcome
Timeframe: Time from date of randomization up to data cutoff (assessed up to 904 days)Population: Safety analysis set included all participants who had received at least 1 dose of any trial treatment.
An Adverse event (AE) was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug or worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent are events between first dose of study drug that were absent before treatment or that worsened relative to pre-treatment state up to 30 days after last administration. TEAEs included both Serious TEAEs and non-serious TEAEs.
Outcome measures
| Measure |
Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil
n=163 Participants
Participants received Cetuximab as an intravenous infusion at an initial dose of 400 milligrams per square meter (mg/m\^2) on Day 1 and a subsequent dose of 250 mg/m\^2 on Day 8 and Day 15 of each 21-day treatment cycle. Cisplatin or Carboplatin (at an equivalent dose in case of intolerability of cisplatin) was administered at a dose of 75 mg/m\^2 as an intravenous infusion on Day 1 of each 21-day treatment cycle. After the administration of cisplatin or carboplatin, participants received 5-fluorouracil (5-FU) at a dose of 750 mg/m\^2/day as a continuous intravenous infusion over 24 hours a day from Day 1 to Day 5 of each 21-day treatment cycle. All treatments were administered up to a maximum of 6 treatment cycles, post this participants without progressive disease (PD) continued to receive monotherapy with cetuximab until occurrence of disease progression or unacceptable toxicity.
|
Cisplatin/Carboplatin + 5-Flurouracil
n=76 Participants
Participants received cisplatin or carboplatin (at an equivalent dose in case of intolerability of cisplatin) was administered at a dose of 75 mg/m\^2 as an intravenous infusion on Day 1 of each 21-day treatment cycle. After the administration of cisplatin or carboplatin, participants received 5-fluorouracil (FU) at a dose of 750 mg/m\^2/day as a continuous intravenous infusion over 24 hours a day from Day 1 to Day 5 of each 21-day treatment cycle. All treatments were administered up to a maximum of 6 treatment cycles.
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), Treatment Emergent Adverse Events Leading to Death and AEs Leading to Discontinuation
TEAEs
|
163 Participants
|
75 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), Treatment Emergent Adverse Events Leading to Death and AEs Leading to Discontinuation
TESAEs
|
46 Participants
|
21 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), Treatment Emergent Adverse Events Leading to Death and AEs Leading to Discontinuation
TEAEs Leading to Death
|
11 Participants
|
8 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), Treatment Emergent Adverse Events Leading to Death and AEs Leading to Discontinuation
AEs Leading to Discontinuation
|
27 Participants
|
8 Participants
|
Adverse Events
Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil
Serious events: 46 serious events
Other events: 163 other events
Deaths: 105 deaths
Cisplatin/Carboplatin + 5-Flurouracil
Serious events: 21 serious events
Other events: 73 other events
Deaths: 54 deaths
Serious adverse events
| Measure |
Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil
n=163 participants at risk
Participants received Cetuximab as an intravenous infusion at an initial dose of 400 milligrams per square meter (mg/m\^2) on Day 1 and a subsequent dose of 250 mg/m\^2 on Day 8 and Day 15 of each 21-day treatment cycle. Cisplatin or Carboplatin (at an equivalent dose in case of intolerability of cisplatin) was administered at a dose of 75 mg/m\^2 as an intravenous infusion on Day 1 of each 21-day treatment cycle. After the administration of cisplatin or carboplatin, participants received 5-fluorouracil (5-FU) at a dose of 750 mg/m\^2/day as a continuous intravenous infusion over 24 hours a day from Day 1 to Day 5 of each 21-day treatment cycle. All treatments were administered up to a maximum of 6 treatment cycles, post this participants without progressive disease (PD) continued to receive monotherapy with cetuximab until occurrence of disease progression or unacceptable toxicity.
|
Cisplatin/Carboplatin + 5-Flurouracil
n=76 participants at risk
Participants received cisplatin or carboplatin (at an equivalent dose in case of intolerability of cisplatin) was administered at a dose of 75 mg/m\^2 as an intravenous infusion on Day 1 of each 21-day treatment cycle. After the administration of cisplatin or carboplatin, participants received 5-fluorouracil (FU) at a dose of 750 mg/m\^2/day as a continuous intravenous infusion over 24 hours a day from Day 1 to Day 5 of each 21-day treatment cycle. All treatments were administered up to a maximum of 6 treatment cycles.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.61%
1/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
2.6%
2/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
1.3%
1/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.2%
2/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
2.6%
2/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
1.3%
1/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Cardiac disorders
Cardiac arrest
|
0.61%
1/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
0.00%
0/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Cardiac disorders
Cardiac failure
|
0.61%
1/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
0.00%
0/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.61%
1/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
0.00%
0/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.2%
2/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
1.3%
1/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Gastrointestinal disorders
Dysphagia
|
0.61%
1/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
0.00%
0/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Gastrointestinal disorders
Glossodynia
|
0.61%
1/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
0.00%
0/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
1.3%
1/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.61%
1/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
0.00%
0/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Gastrointestinal disorders
Oesophageal polyp
|
0.61%
1/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
0.00%
0/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
1.3%
1/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.61%
1/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
0.00%
0/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Gastrointestinal disorders
Vomiting
|
0.61%
1/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
0.00%
0/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
General disorders
Death
|
1.2%
2/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
0.00%
0/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
General disorders
Pain
|
0.61%
1/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
0.00%
0/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Infections and infestations
Infected fistula
|
0.00%
0/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
1.3%
1/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Infections and infestations
Lung infection
|
3.7%
6/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
5.3%
4/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Infections and infestations
Oral infection
|
0.00%
0/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
1.3%
1/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Infections and infestations
Otitis media acute
|
0.61%
1/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
0.00%
0/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Infections and infestations
Pneumonia
|
1.2%
2/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
0.00%
0/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Infections and infestations
Septic shock
|
0.00%
0/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
1.3%
1/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Infections and infestations
Soft tissue infection
|
0.61%
1/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
0.00%
0/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Infections and infestations
Tracheostomy infection
|
0.61%
1/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
0.00%
0/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
2.6%
2/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Infections and infestations
Wound infection
|
0.61%
1/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
0.00%
0/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
1.3%
1/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.61%
1/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
0.00%
0/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.61%
1/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
0.00%
0/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Investigations
Acid base balance abnormal
|
0.61%
1/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
0.00%
0/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Investigations
Alanine aminotransferase increased
|
0.61%
1/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
0.00%
0/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Investigations
Aspartate aminotransferase increased
|
0.61%
1/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
0.00%
0/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Investigations
Blood creatinine increased
|
0.61%
1/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
0.00%
0/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.61%
1/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
0.00%
0/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
1.3%
1/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Investigations
Platelet count decreased
|
0.61%
1/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
1.3%
1/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
2.6%
2/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
1.3%
1/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.61%
1/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
0.00%
0/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.61%
1/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
0.00%
0/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
1.2%
2/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
0.00%
0/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.00%
0/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
1.3%
1/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oncologic complication
|
0.00%
0/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
1.3%
1/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor haemorrhage
|
0.61%
1/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
3.9%
3/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.61%
1/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
0.00%
0/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Nervous system disorders
Cerebral infarction
|
1.2%
2/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
0.00%
0/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Nervous system disorders
Cerebrovascular insufficiency
|
0.61%
1/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
0.00%
0/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
1.3%
1/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.61%
1/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
0.00%
0/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.61%
1/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
0.00%
0/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.1%
5/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
0.00%
0/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.61%
1/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
0.00%
0/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal obstruction
|
0.61%
1/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
0.00%
0/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.00%
0/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
1.3%
1/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal pain
|
0.61%
1/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
0.00%
0/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.00%
0/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
2.6%
2/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.61%
1/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
0.00%
0/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.61%
1/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
0.00%
0/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.61%
1/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
0.00%
0/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.2%
2/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
0.00%
0/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
1.3%
1/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Vascular disorders
Peripheral artery occlusion
|
0.61%
1/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
0.00%
0/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Vascular disorders
Venous haemorrhage
|
0.61%
1/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
0.00%
0/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Vascular disorders
Venous thrombosis limb
|
0.61%
1/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
0.00%
0/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
Other adverse events
| Measure |
Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil
n=163 participants at risk
Participants received Cetuximab as an intravenous infusion at an initial dose of 400 milligrams per square meter (mg/m\^2) on Day 1 and a subsequent dose of 250 mg/m\^2 on Day 8 and Day 15 of each 21-day treatment cycle. Cisplatin or Carboplatin (at an equivalent dose in case of intolerability of cisplatin) was administered at a dose of 75 mg/m\^2 as an intravenous infusion on Day 1 of each 21-day treatment cycle. After the administration of cisplatin or carboplatin, participants received 5-fluorouracil (5-FU) at a dose of 750 mg/m\^2/day as a continuous intravenous infusion over 24 hours a day from Day 1 to Day 5 of each 21-day treatment cycle. All treatments were administered up to a maximum of 6 treatment cycles, post this participants without progressive disease (PD) continued to receive monotherapy with cetuximab until occurrence of disease progression or unacceptable toxicity.
|
Cisplatin/Carboplatin + 5-Flurouracil
n=76 participants at risk
Participants received cisplatin or carboplatin (at an equivalent dose in case of intolerability of cisplatin) was administered at a dose of 75 mg/m\^2 as an intravenous infusion on Day 1 of each 21-day treatment cycle. After the administration of cisplatin or carboplatin, participants received 5-fluorouracil (FU) at a dose of 750 mg/m\^2/day as a continuous intravenous infusion over 24 hours a day from Day 1 to Day 5 of each 21-day treatment cycle. All treatments were administered up to a maximum of 6 treatment cycles.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
44.8%
73/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
47.4%
36/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Blood and lymphatic system disorders
Leukopenia
|
33.7%
55/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
31.6%
24/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Blood and lymphatic system disorders
Neutropenia
|
35.6%
58/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
28.9%
22/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
14.1%
23/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
9.2%
7/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Cardiac disorders
Palpitations
|
4.3%
7/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
5.3%
4/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Gastrointestinal disorders
Abdominal distension
|
9.2%
15/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
3.9%
3/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
11/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
1.3%
1/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Gastrointestinal disorders
Constipation
|
44.8%
73/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
40.8%
31/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Gastrointestinal disorders
Diarrhoea
|
27.0%
44/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
13.2%
10/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
7.4%
12/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
1.3%
1/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Gastrointestinal disorders
Mouth ulceration
|
18.4%
30/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
10.5%
8/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Gastrointestinal disorders
Nausea
|
57.1%
93/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
67.1%
51/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Gastrointestinal disorders
Oral pain
|
5.5%
9/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
3.9%
3/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Gastrointestinal disorders
Stomatitis
|
27.0%
44/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
17.1%
13/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Gastrointestinal disorders
Vomiting
|
36.8%
60/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
48.7%
37/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
General disorders
Asthenia
|
24.5%
40/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
22.4%
17/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
General disorders
Chest discomfort
|
6.1%
10/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
5.3%
4/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
General disorders
Facial pain
|
1.2%
2/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
7.9%
6/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
General disorders
Fatigue
|
5.5%
9/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
1.3%
1/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
General disorders
Pyrexia
|
25.8%
42/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
15.8%
12/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Infections and infestations
Lung infection
|
9.8%
16/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
2.6%
2/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Infections and infestations
Paronychia
|
8.0%
13/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
0.00%
0/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.0%
13/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
5.3%
4/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
General disorders
Malaise
|
7.4%
12/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
10.5%
8/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Investigations
Alanine aminotransferase increased
|
7.4%
12/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
5.3%
4/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Investigations
Aspartate aminotransferase increased
|
5.5%
9/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
2.6%
2/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Investigations
Blood creatinine increased
|
2.5%
4/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
5.3%
4/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Investigations
Haemoglobin decreased
|
8.6%
14/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
6.6%
5/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Investigations
Lymphocyte count decreased
|
3.7%
6/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
6.6%
5/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Investigations
Neutrophil count decreased
|
28.8%
47/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
26.3%
20/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Investigations
Platelet count decreased
|
12.3%
20/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
14.5%
11/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Investigations
Red blood cell count decreased
|
6.7%
11/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
7.9%
6/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Investigations
Weight decreased
|
63.2%
103/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
40.8%
31/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Investigations
Weight increased
|
5.5%
9/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
3.9%
3/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Investigations
White blood cell count decreased
|
38.0%
62/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
32.9%
25/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Investigations
White blood cell count increased
|
2.5%
4/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
6.6%
5/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
41.1%
67/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
44.7%
34/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.61%
1/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
5.3%
4/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
13.5%
22/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
17.1%
13/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
19.6%
32/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
11.8%
9/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
16.0%
26/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
15.8%
12/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
34.4%
56/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
23.7%
18/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
24.5%
40/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
9.2%
7/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
27.0%
44/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
27.6%
21/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
7.4%
12/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
7.9%
6/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.4%
12/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
3.9%
3/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Nervous system disorders
Dizziness
|
14.1%
23/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
15.8%
12/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Nervous system disorders
Headache
|
6.1%
10/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
6.6%
5/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Nervous system disorders
Poor quality sleep
|
6.1%
10/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
6.6%
5/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Psychiatric disorders
Depressed mood
|
2.5%
4/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
9.2%
7/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Psychiatric disorders
Insomnia
|
9.8%
16/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
5.3%
4/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.4%
30/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
15.8%
12/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
9.2%
15/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
2.6%
2/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
12.9%
21/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
7.9%
6/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.5%
9/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
5.3%
4/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
21.5%
35/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
0.00%
0/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.4%
12/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
0.00%
0/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
7.4%
12/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
2.6%
2/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.2%
15/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
0.00%
0/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Skin and subcutaneous tissue disorders
Rash
|
47.2%
77/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
1.3%
1/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Vascular disorders
Hypertension
|
2.5%
4/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
6.6%
5/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
|
Vascular disorders
Hypotension
|
6.1%
10/163 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
1.3%
1/76 • Time from date of randomization up to data cutoff (assessed up to 904 days)
Treatment emergent serious and non-serious adverse events are reported below.
|
Additional Information
Communication Center
Merck KGaA, Darmstadt, Germany
Phone: +49-6151-72-5200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER