Trial Outcomes & Findings for Study of Taxane/Carboplatin +/- Cetuximab as First-Line Treatment for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer (NCT NCT00112294)
NCT ID: NCT00112294
Last Updated: 2015-12-24
Results Overview
Interval between randomization date \& earliest date of disease progression/death due to any cause, assessed by the Independent Radiology Review Committee (IRRC) using modified World Health Organization (WHO) criteria to define progressive disease (PD): \>=25% increase in sum of products of diameters (SOPD) of lesions compared with smallest SOPD recorded for study period or progression of any non-index lesion/appearance of new lesion. If no progression/death, date of last tumor assessment used. For participants who had no on-study tumor assessments \& were still alive, date of randomization used.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
755 participants
Primary outcome timeframe
From randomization to evidence of disease progression/death or date of last tumor assessment (up to 26 months).
Results posted on
2015-12-24
Participant Flow
755 participants were enrolled and 676 were randomized into the study. 79 participants were not randomized (6 deaths; 1 lost to follow up; 1 poor/non-compliance; 49 no longer met study criteria; 17 participant request; 2 required concurrent radiation; 1 insurance issue; 1 doctor discretion; 1 unknown).
Participant milestones
| Measure |
Cetuximab+Taxane+Carboplatin (C/T/C)
Cetuximab was administered at an initial dose (Week 1) of 400 mg/m\^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m\^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
|
Taxane+Carboplatin (T/C)
A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
325
|
320
|
|
Overall Study
Never Treated
|
13
|
18
|
|
Overall Study
COMPLETED
|
320
|
320
|
|
Overall Study
NOT COMPLETED
|
5
|
0
|
Reasons for withdrawal
| Measure |
Cetuximab+Taxane+Carboplatin (C/T/C)
Cetuximab was administered at an initial dose (Week 1) of 400 mg/m\^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m\^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
|
Taxane+Carboplatin (T/C)
A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
|
|---|---|---|
|
Overall Study
Still on study
|
5
|
0
|
Baseline Characteristics
Study of Taxane/Carboplatin +/- Cetuximab as First-Line Treatment for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Cetuximab+Taxane+Carboplatin (C/T/C)
n=338 Participants
Cetuximab was administered at an initial dose (Week 1) of 400 mg/m\^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m\^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
|
Taxane+Carboplatin (T/C)
n=338 Participants
A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
|
Total
n=676 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.0 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
63.9 years
STANDARD_DEVIATION 10.3 • n=7 Participants
|
64.0 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
|
Age, Customized
<65 years
|
171 participants
n=5 Participants
|
165 participants
n=7 Participants
|
336 participants
n=5 Participants
|
|
Age, Customized
>= 65 years
|
167 participants
n=5 Participants
|
173 participants
n=7 Participants
|
340 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
146 Participants
n=5 Participants
|
134 Participants
n=7 Participants
|
280 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
192 Participants
n=5 Participants
|
204 Participants
n=7 Participants
|
396 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
25 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
296 Participants
n=5 Participants
|
300 Participants
n=7 Participants
|
596 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other race
|
11 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
0=fully active
|
110 Participants
n=5 Participants
|
114 Participants
n=7 Participants
|
224 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
1=restricted physically strenuous activity
|
221 Participants
n=5 Participants
|
220 Participants
n=7 Participants
|
441 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
2=ambulatory but unable to work
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
3=capable of only limited self care
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
4=completely disabled
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
5=dead
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Missing
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Weight
|
75.0 kg
STANDARD_DEVIATION 17.1 • n=5 Participants
|
75.3 kg
STANDARD_DEVIATION 18.1 • n=7 Participants
|
75.1 kg
STANDARD_DEVIATION 17.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: From randomization to evidence of disease progression/death or date of last tumor assessment (up to 26 months).Population: All randomized participants (intention to treat population).
Interval between randomization date \& earliest date of disease progression/death due to any cause, assessed by the Independent Radiology Review Committee (IRRC) using modified World Health Organization (WHO) criteria to define progressive disease (PD): \>=25% increase in sum of products of diameters (SOPD) of lesions compared with smallest SOPD recorded for study period or progression of any non-index lesion/appearance of new lesion. If no progression/death, date of last tumor assessment used. For participants who had no on-study tumor assessments \& were still alive, date of randomization used.
Outcome measures
| Measure |
Cetuximab+Taxane+Carboplatin (C/T/C)
n=338 Participants
Cetuximab was administered at an initial dose (Week 1) of 400 mg/m\^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m\^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
|
Taxane+Carboplatin (T/C)
n=338 Participants
A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
|
|---|---|---|
|
Median Number of Months of Progression-free Survival (PFS)
|
4.40 Months
Interval 4.11 to 5.06
|
4.24 Months
Interval 3.94 to 4.63
|
SECONDARY outcome
Timeframe: From randomization to end of study drug therapy (up to 174 weeks).Population: All randomized participants (intention to treat population).
Tumor response was defined as the number of participants whose best response was CR or PR, per the IRRC assessment, using the modified WHO criteria: CR: disappearance of all index/non-index lesions; PR: \>= 50% reduction in the SOPD of index lesions compared with the baseline SOPD, with no evidence of progression. To qualify as CR or PR, no new lesions could be present.
Outcome measures
| Measure |
Cetuximab+Taxane+Carboplatin (C/T/C)
n=338 Participants
Cetuximab was administered at an initial dose (Week 1) of 400 mg/m\^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m\^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
|
Taxane+Carboplatin (T/C)
n=338 Participants
A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
|
|---|---|---|
|
Number of Participants With Complete Response (CR) or Partial Response (PR)
|
87 Participants
|
58 Participants
|
SECONDARY outcome
Timeframe: From randomization to end of study drug therapy (up to 174 weeks).Population: All randomized participants (intention to treat population).
Disease control was defined as the number of participants whose best response was CR, PR, or SD, per the IRRC assessment, using the modified WHO criteria: CR: disappearance of all index/non-index lesions; PR:\>= 50% reduction in the SOPD of index lesions compared with the baseline SOPD, with no evidence of progression (to qualify as CR or PR, no new lesions could be present); SD: participants who did not meet the criteria for CR, PR, or PD (PD:\>=25% increase in SOPD of lesions compared with smallest SOPD recorded for study period or progression of any non-index lesion/appearance of new lesion).
Outcome measures
| Measure |
Cetuximab+Taxane+Carboplatin (C/T/C)
n=338 Participants
Cetuximab was administered at an initial dose (Week 1) of 400 mg/m\^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m\^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
|
Taxane+Carboplatin (T/C)
n=338 Participants
A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
|
|---|---|---|
|
Number of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD)
|
230 Participants
|
212 Participants
|
SECONDARY outcome
Timeframe: Time from first occurrence of CR or PR (whichever was recorded first) to the date of PD, death or date of last tumor assessment (up to 19 months).Population: All randomized participants with a best response of CR or PR.
Median number of months of response (time from first occurrence of CR/PR to date of PD/death, \[per IRRC assessment,using modified WHO criteria\]) calculated for participants whose best response=CR/PR.For participants who did not progress/die, date of last tumor assessment used.CR:disappearance of all index/non-index lesions;PR:\>= 50% reduction in SOPD of index lesions compared with baseline, no evidence of progression.No new lesions present.PD:\>=25% increase in SOPD of lesions compared with smallest SOPD recorded for study period or progression of any non-index lesion/appearance of new lesion.
Outcome measures
| Measure |
Cetuximab+Taxane+Carboplatin (C/T/C)
n=87 Participants
Cetuximab was administered at an initial dose (Week 1) of 400 mg/m\^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m\^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
|
Taxane+Carboplatin (T/C)
n=58 Participants
A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
|
|---|---|---|
|
Median Number of Months of Response
|
5.55 Months
Interval 4.4 to 6.83
|
4.90 Months
Interval 4.24 to 5.72
|
SECONDARY outcome
Timeframe: Time from first dose of study therapy to the date of PR or CR, whichever occurred first (up to 13 months).Population: All randomized participants with a best response of CR or PR.
The median number of months to response was calculated for participants whose best response was CR or PR. It was defined as the time from the first dose of study therapy to the first date that criteria for PR or CR (whichever occurred first)were met. Response was assessed by the IRRC, using the modified WHO criteria: CR: disappearance of all index/non-index lesions; PR: \>= 50% reduction in the SOPD of index lesions compared with the baseline SOPD, with no evidence of progression. To qualify as CR or PR, no new lesions could be present.
Outcome measures
| Measure |
Cetuximab+Taxane+Carboplatin (C/T/C)
n=87 Participants
Cetuximab was administered at an initial dose (Week 1) of 400 mg/m\^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m\^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
|
Taxane+Carboplatin (T/C)
n=58 Participants
A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
|
|---|---|---|
|
Median Number of Months to Response
|
1.38 Months
Interval 1.08 to 12.65
|
1.35 Months
Interval 0.99 to 4.83
|
SECONDARY outcome
Timeframe: From randomization to death or date of last contact (up to 41 months).Population: All randomized participants (intention to treat population).
The median number of months of survival was defined as the time from randomization to the date of death. For participants who did not die, the date of last contact was used.
Outcome measures
| Measure |
Cetuximab+Taxane+Carboplatin (C/T/C)
n=338 Participants
Cetuximab was administered at an initial dose (Week 1) of 400 mg/m\^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m\^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
|
Taxane+Carboplatin (T/C)
n=338 Participants
A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
|
|---|---|---|
|
Median Number of Months of Survival
|
9.69 Months
Interval 8.28 to 11.5
|
8.38 Months
Interval 7.33 to 9.92
|
SECONDARY outcome
Timeframe: From randomization to evidence of disease progression/death or date of last symptom assessment (up to 33 weeks).Population: All randomized participants who completed a baseline FACT-LCS questionnaire (ie, who completed a questionnaire \<=14 days prior to treatment, or if they were never treated, \<=14 days prior to randomization) and who had a baseline score of 26 or less.
Symptoms were assessed using the Functional Assessment of Cancer Therapy - Lung Cancer Subscale (FACT-LCS) questionnaire. This 7-item scale has scores ranging from 0 (severely symptomatic in all symptoms assessed) to 28 (symptom-free on all symptoms assessed). Symptom response (improvement) was defined as \>= 2-point increase from baseline in score (maintained for 2 consecutive assessments, at least 3 weeks apart). Participants with a baseline score of \>= 27 were not evaluable, as it would not have been possible to show an improvement. Participants with no baseline data were also not evaluable.
Outcome measures
| Measure |
Cetuximab+Taxane+Carboplatin (C/T/C)
n=328 Participants
Cetuximab was administered at an initial dose (Week 1) of 400 mg/m\^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m\^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
|
Taxane+Carboplatin (T/C)
n=323 Participants
A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
|
|---|---|---|
|
Number of Participants With Improvement of Symptoms
|
107 Participants
|
92 Participants
|
SECONDARY outcome
Timeframe: From randomization to evidence of disease progression/death or date of last symptom assessment (up to 33 weeks).Population: All randomized participants who completed baseline FACT-LCS questionnaire (ie, completed questionnaire \<=14 days prior to treatment, or if they were never treated, \<=14 days prior to randomization) and who had a baseline score greater than or equal to 2. As the median was not reached, no data are presented here (see Outcome Measure 15).
Symptoms were assessed using the FACT-LCS questionnaire. This 7-item scale has scores ranging from 0 (severely symptomatic) to 28 (symptom-free). Symptomatic progression was defined as \>= 2-point decrease from baseline in score (maintained for 2 consecutive assessments at least 3 weeks apart). Time to symptomatic progression was defined as the time from randomization to date of symptoms worsening. For participants with no symptom progression, the date of the last symptom assessment was used. See also Outcome Measure 15.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From start of study drug therapy up to 30 days after the last dose (up to 178 weeks).Population: All treated participants. The AEs represented here include SAEs, which are not included in the AE count represented in the AE xml upload section. As such, these numbers may not match.
An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition (even if not caused by the study drug). An SAE was defined as an AE that resulted in death, was life-threatening, required hospitalization (or prolongation of existing hospitalization), or was an important medical event.
Outcome measures
| Measure |
Cetuximab+Taxane+Carboplatin (C/T/C)
n=325 Participants
Cetuximab was administered at an initial dose (Week 1) of 400 mg/m\^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m\^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
|
Taxane+Carboplatin (T/C)
n=320 Participants
A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
|
|---|---|---|
|
Number of Participants Who Died, or Experienced Other Serious Adverse Events (SAEs) and Adverse Events (AEs)
Death
|
38 Participants
|
27 Participants
|
|
Number of Participants Who Died, or Experienced Other Serious Adverse Events (SAEs) and Adverse Events (AEs)
Serious adverse events
|
183 Participants
|
121 Participants
|
|
Number of Participants Who Died, or Experienced Other Serious Adverse Events (SAEs) and Adverse Events (AEs)
Adverse events
|
324 Participants
|
320 Participants
|
SECONDARY outcome
Timeframe: From start of study drug therapy up to 30 days after the last dose (up to 178 weeks).Population: All treated participants.
An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition (even if not caused by the study drug). The results presented are stratified according to which drug was discontinued.
Outcome measures
| Measure |
Cetuximab+Taxane+Carboplatin (C/T/C)
n=325 Participants
Cetuximab was administered at an initial dose (Week 1) of 400 mg/m\^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m\^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
|
Taxane+Carboplatin (T/C)
n=320 Participants
A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
|
|---|---|---|
|
Number of Participants Experiencing AEs Leading to Study Drug Discontinuation
Cetuximab
|
100 participants
|
0 participants
|
|
Number of Participants Experiencing AEs Leading to Study Drug Discontinuation
Taxane
|
80 participants
|
54 participants
|
|
Number of Participants Experiencing AEs Leading to Study Drug Discontinuation
Carboplatin
|
78 participants
|
52 participants
|
SECONDARY outcome
Timeframe: From start of study drug therapy up to 30 days after the last dose (up to 178 weeks).Population: All treated participants.
An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition (even if not caused by the study drug). For this study, it was decided that AEs that were categorized under the composite term "acneform rash" were of particular importance. These AEs were: rash, rash pustular, rash erythematous, dermatitis acneiform, dermatitis exfoliative, rash papular, rash pruritic, rash generalised, rash macular, rash maculo-papular, acne, acne pustular, skin desquamation and dry skin.
Outcome measures
| Measure |
Cetuximab+Taxane+Carboplatin (C/T/C)
n=325 Participants
Cetuximab was administered at an initial dose (Week 1) of 400 mg/m\^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m\^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
|
Taxane+Carboplatin (T/C)
n=320 Participants
A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
|
|---|---|---|
|
Number of Participants Experiencing Other Significant AEs: Acneform Rash
|
246 Participants
|
56 Participants
|
SECONDARY outcome
Timeframe: From start of study drug therapy up to 30 days after the last dose (up to 178 weeks).Population: All treated participants.
AE=any new untoward medical occurrence or worsening of pre-existing medical condition (even if not caused by the study drug). For this study, it was decided that AEs that were categorized under the composite term "infusion reaction" were of particular importance. These AEs were: infusion-related reaction, hypersensitivity, anaphylactic reaction, anaphylactic shock, and anaphylactoid reaction regardless of when they occurred. The terms dyspnea, pyrexia and chills were also grouped under infusion reaction, provided the onset date of these toxicities occurred on the first day of study treatment.
Outcome measures
| Measure |
Cetuximab+Taxane+Carboplatin (C/T/C)
n=325 Participants
Cetuximab was administered at an initial dose (Week 1) of 400 mg/m\^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m\^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
|
Taxane+Carboplatin (T/C)
n=320 Participants
A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
|
|---|---|---|
|
Number of Participants Experiencing Other Significant AEs: Infusion Reaction
|
45 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: From start of study drug therapy up to 30 days after the last dose (up to 178 weeks).Population: All treated participants.
An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition (even if not caused by the study drug). For this study, it was decided that AEs that were categorized under the composite term "cardiac AE" were of particular importance. These AEs, coded as preferred or other level Medical Dictionary for Regulatory Activities \[MedDRA\] terms were: coronary artery disorders, cardiac arrhythmias, heart failures not elsewhere classified, left ventricular failures, sudden cardiac death, cardiac death and sudden death.
Outcome measures
| Measure |
Cetuximab+Taxane+Carboplatin (C/T/C)
n=325 Participants
Cetuximab was administered at an initial dose (Week 1) of 400 mg/m\^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m\^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
|
Taxane+Carboplatin (T/C)
n=320 Participants
A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
|
|---|---|---|
|
Number of Participants Experiencing Other Significant AEs: Cardiac AEs
|
58 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: From start of study drug therapy up to 30 days after the last dose (up to 178 weeks).Population: All treated participants.
Abnormalities were graded according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 3.0. The scale is graded from 1 (least severe) to 4 (life threatening). Grade 3 and 4 criteria are defined as follows: Neutropenia: Grade 3, neutrophils \<1.0 - 0.5 x 10\^9/L; Grade 4, \<0.5 x 10\^9/L. Leukopenia: Grade 3, leukocytes \<2.0 - 1.0 x 10\^9/L; Grade 4, \<1.0 x 10\^9/L. Thrombocytopenia: Grade 3, platelets \<50.0 - 25.0 x 10\^9/L; Grade 4, \<25.0 x 10\^9/L. Anemia: Grade 3, hemoglobin \<4.9 - 4.0 millimoles (mmol)/L, Grade 4, \<4.0 mmol/L.
Outcome measures
| Measure |
Cetuximab+Taxane+Carboplatin (C/T/C)
n=325 Participants
Cetuximab was administered at an initial dose (Week 1) of 400 mg/m\^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m\^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
|
Taxane+Carboplatin (T/C)
n=320 Participants
A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
|
|---|---|---|
|
Number of Participants Who Exprienced the Most Frequent Grade 3-4 Hematology Abnormalities Occurring in >=5% Participants
Neutropenia
|
198 Participants
|
177 Participants
|
|
Number of Participants Who Exprienced the Most Frequent Grade 3-4 Hematology Abnormalities Occurring in >=5% Participants
Leukopenia
|
139 Participants
|
97 Participants
|
|
Number of Participants Who Exprienced the Most Frequent Grade 3-4 Hematology Abnormalities Occurring in >=5% Participants
Thrombocytopenia
|
33 Participants
|
29 Participants
|
|
Number of Participants Who Exprienced the Most Frequent Grade 3-4 Hematology Abnormalities Occurring in >=5% Participants
Anemia
|
17 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: From start of study drug therapy up to 30 days after the last dose (up to 178 weeks).Population: All treated participants.
Abnormalities were graded according to the NCI CTC, version 3.0. The scale is graded from 1 (least severe) to 4 (life threatening). Grade 3 and 4 criteria are defined as follows: Hyperglycemia (non-fasting): Grade 3, serum glucose \>13.9 - 27.8 mmol/L; Grade 4 \>27.8 mmol/L or acidosis. Hypomagnesemia: Grade 3, serum magnesium \>1.23 - 3.30 mmol/L; Grade 4 \>3.30 mmol/L. Hyponatremia: Grade 3, serum sodium \<130 - 120 mmol/L; Grade 4 \<120 mmol/L. Low albumin: Grade 3, serum albumin \<20 g/L; Grade 4 not applicable.
Outcome measures
| Measure |
Cetuximab+Taxane+Carboplatin (C/T/C)
n=325 Participants
Cetuximab was administered at an initial dose (Week 1) of 400 mg/m\^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m\^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
|
Taxane+Carboplatin (T/C)
n=320 Participants
A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
|
|---|---|---|
|
Number of Participants Who Experienced the Most Frequent Grade 3-4 Serum Chemistry Abnormalities Occurring in >=5% Participants
Hyperglycemia (non-fasting)
|
33 Participants
|
36 Participants
|
|
Number of Participants Who Experienced the Most Frequent Grade 3-4 Serum Chemistry Abnormalities Occurring in >=5% Participants
Hypomagnesemia
|
26 Participants
|
2 Participants
|
|
Number of Participants Who Experienced the Most Frequent Grade 3-4 Serum Chemistry Abnormalities Occurring in >=5% Participants
Hyponatremia
|
25 Participants
|
21 Participants
|
|
Number of Participants Who Experienced the Most Frequent Grade 3-4 Serum Chemistry Abnormalities Occurring in >=5% Participants
Low albumin
|
17 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Day 1 of each cycle of treatment, at the end of study therapy evaluation and at the first follow-up visit (6 weeks after the end of study therapy evaluation).Population: This analysis was not performed.
Participants were to complete log to collect information on unscheduled visits to physicians,clinics,hospitals \& other unscheduled major procedures.If asked, participants were to complete and return log to site upon routinely scheduled visits.The purpose of this exploratory analysis was to understand the economical implications as a secondary objective.This was not a pivotal study \& therefore not needed to support any arguments with regulatory authorities concerning cost-benefit,hence,it was not necessary to conduct this analysis. There is no intent on conducting this analysis in the future.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From randomization to evidence of disease progression/death or date of last symptom assessment (up to 33 weeks).Population: All randomized participants who completed a baseline FACT-LCS questionnaire (ie, completed questionnaire \<=14 days prior to treatment, or if they were never treated, \<=14 days prior to randomization). n = number of participants with a score at both the baseline and at the specified time point (each arm respectively).
Symptoms were assessed using the FACT-LCS questionnaire. This 7-item scale has scores ranging from 0 (severely symptomatic) to 28 (symptom-free). The median change from baseline score was calculated at 3-weekly intervals. See also Outcome Measure 8.
Outcome measures
| Measure |
Cetuximab+Taxane+Carboplatin (C/T/C)
n=336 Participants
Cetuximab was administered at an initial dose (Week 1) of 400 mg/m\^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m\^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
|
Taxane+Carboplatin (T/C)
n=335 Participants
A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
|
|---|---|---|
|
Median Change From Baseline in Symptoms, by Time Point
3 weeks (n = 286, 257)
|
1.0 Units on a scale
Interval -1.0 to 3.0
|
0.8 Units on a scale
Interval -2.0 to 3.0
|
|
Median Change From Baseline in Symptoms, by Time Point
6 weeks (n = 254, 221)
|
1.0 Units on a scale
Interval -2.0 to 4.0
|
1.0 Units on a scale
Interval -2.0 to 4.0
|
|
Median Change From Baseline in Symptoms, by Time Point
9 weeks (n = 203, 175)
|
1.0 Units on a scale
Interval -2.0 to 4.0
|
1.0 Units on a scale
Interval -2.0 to 4.0
|
|
Median Change From Baseline in Symptoms, by Time Point
12 weeks (n = 178, 161)
|
1.0 Units on a scale
Interval -2.0 to 4.0
|
0.0 Units on a scale
Interval -2.0 to 4.0
|
|
Median Change From Baseline in Symptoms, by Time Point
15 weeks (n = 155, 121)
|
1.0 Units on a scale
Interval -2.0 to 4.0
|
1.0 Units on a scale
Interval -2.0 to 5.0
|
|
Median Change From Baseline in Symptoms, by Time Point
18 weeks (n = 126, 91)
|
1.0 Units on a scale
Interval -1.0 to 4.0
|
2.0 Units on a scale
Interval -2.0 to 5.0
|
|
Median Change From Baseline in Symptoms, by Time Point
21 weeks (n = 96, 43)
|
2.0 Units on a scale
Interval -1.0 to 4.0
|
3.0 Units on a scale
Interval -1.0 to 7.0
|
|
Median Change From Baseline in Symptoms, by Time Point
24 weeks (n = 90, 41)
|
2.0 Units on a scale
Interval -2.0 to 5.0
|
1.0 Units on a scale
Interval -1.0 to 5.0
|
|
Median Change From Baseline in Symptoms, by Time Point
27 weeks (n = 60, 22)
|
3.0 Units on a scale
Interval -1.0 to 5.0
|
3.5 Units on a scale
Interval -1.0 to 7.0
|
|
Median Change From Baseline in Symptoms, by Time Point
30 weeks (n = 56, 15)
|
1.5 Units on a scale
Interval -1.0 to 5.0
|
3.0 Units on a scale
Interval 0.0 to 5.0
|
|
Median Change From Baseline in Symptoms, by Time Point
33 weeks (n = 43, 7)
|
2.1 Units on a scale
Interval -1.0 to 6.0
|
3.0 Units on a scale
Interval -1.0 to 8.0
|
Adverse Events
Cetuximab+Taxane+Carboplatin
Serious events: 183 serious events
Other events: 322 other events
Deaths: 0 deaths
Taxane+Carboplatin
Serious events: 121 serious events
Other events: 317 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cetuximab+Taxane+Carboplatin
n=325 participants at risk
|
Taxane+Carboplatin
n=320 participants at risk
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.31%
1/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.31%
1/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Infections and infestations
Urinary tract infection
|
0.92%
3/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.31%
1/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Infections and infestations
Urosepsis
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.31%
1/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Ear and labyrinth disorders
Vertigo labyrinthine
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Gastrointestinal disorders
Vomiting
|
2.2%
7/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
1.6%
5/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Gastrointestinal disorders
Vomiting projectile
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Renal and urinary disorders
Nephritis
|
0.00%
0/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.31%
1/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.8%
9/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
1.2%
4/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Infections and infestations
Neutropenic infection
|
0.62%
2/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.62%
2/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
General disorders
Non-cardiac chest pain
|
0.62%
2/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.94%
3/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.31%
1/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.31%
1/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.31%
1/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.62%
2/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
General disorders
Pain
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Cardiac disorders
Pericardial effusion
|
1.2%
4/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.31%
1/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pericardial effusion malignant
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Vascular disorders
Peripheral embolism
|
0.00%
0/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.31%
1/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.31%
1/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Investigations
Platelet count decreased
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.31%
1/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.8%
9/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
2.2%
7/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Infections and infestations
Pneumonia
|
5.5%
18/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
3.4%
11/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.62%
2/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.94%
3/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
1.2%
4/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine carcinoma
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.31%
1/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Nervous system disorders
Spinal cord compression
|
1.2%
4/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Infections and infestations
Staphylococcal infection
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Gastrointestinal disorders
Stomatitis
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.31%
1/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Infections and infestations
Streptococcal infection
|
0.00%
0/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.31%
1/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.31%
1/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Vascular disorders
Superior vena caval occlusion
|
0.92%
3/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.62%
2/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Nervous system disorders
Syncope
|
0.62%
2/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
1.6%
5/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Nervous system disorders
Syncope vasovagal
|
0.00%
0/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.31%
1/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Cardiac disorders
Tachycardia
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.31%
1/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.62%
2/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.31%
1/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Vascular disorders
Thrombosis
|
0.92%
3/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.31%
1/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.5%
8/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
1.2%
4/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
General disorders
Pyrexia
|
0.92%
3/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Injury, poisoning and procedural complications
Radiation oesophagitis
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Renal and urinary disorders
Renal failure
|
1.8%
6/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.31%
1/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Renal and urinary disorders
Renal failure acute
|
1.2%
4/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.62%
2/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Renal and urinary disorders
Renal pain
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.5%
5/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
1.2%
4/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Infections and infestations
Sepsis
|
1.8%
6/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.94%
3/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Infections and infestations
Abdominal abscess
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.2%
4/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
1.2%
4/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.31%
1/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Renal and urinary disorders
Acute prerenal failure
|
0.00%
0/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.31%
1/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.31%
1/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.31%
1/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
General disorders
Adverse drug reaction
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.92%
3/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.31%
1/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Immune system disorders
Anaphylactic reaction
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Vascular disorders
Aortic stenosis
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.31%
1/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Injury, poisoning and procedural complications
Arterial injury
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
General disorders
Asthenia
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.62%
2/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Cardiac disorders
Atrial fibrillation
|
1.8%
6/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.31%
1/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.31%
1/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.62%
2/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Infections and infestations
Bacteraemia
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.31%
1/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Psychiatric disorders
Bipolar disorder
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.31%
1/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.31%
1/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.31%
1/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Cardiac disorders
Cardiac arrest
|
0.92%
3/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.94%
3/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.62%
2/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Infections and infestations
Cellulitis
|
0.92%
3/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Nervous system disorders
Cerebral artery embolism
|
0.00%
0/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.31%
1/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.62%
2/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.94%
3/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.5%
5/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
1.2%
4/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Nervous system disorders
Cervical cord compression
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
General disorders
Chest discomfort
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
General disorders
Chills
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.62%
2/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Infections and infestations
Clostridial infection
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Nervous system disorders
Cognitive disorder
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.31%
1/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Gastrointestinal disorders
Colitis
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Psychiatric disorders
Confusional state
|
1.2%
4/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.62%
2/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Gastrointestinal disorders
Constipation
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.94%
3/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Nervous system disorders
Convulsion
|
1.2%
4/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.62%
2/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Vascular disorders
Deep vein thrombosis
|
0.92%
3/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
1.6%
5/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Metabolism and nutrition disorders
Dehydration
|
7.4%
24/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
3.4%
11/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.8%
6/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
1.6%
5/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.31%
1/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Infections and infestations
Diverticulitis
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Gastrointestinal disorders
Diverticulum
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.31%
1/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Gastrointestinal disorders
Dysphagia
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.1%
10/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
2.5%
8/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.31%
1/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Vascular disorders
Embolism
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.31%
1/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Injury, poisoning and procedural complications
Fall
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
General disorders
Fatigue
|
0.92%
3/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.31%
1/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.3%
14/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
2.5%
8/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Gastrointestinal disorders
Gastritis
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.00%
0/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.31%
1/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.62%
2/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
General disorders
General physical health deterioration
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.31%
1/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Vascular disorders
Haematoma
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.31%
1/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.62%
2/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.62%
2/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Nervous system disorders
Headache
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Infections and infestations
Hepatitis C
|
0.00%
0/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.31%
1/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Respiratory, thoracic and mediastinal disorders
Hydropneumothorax
|
0.00%
0/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.31%
1/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Immune system disorders
Hypersensitivity
|
3.4%
11/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.31%
1/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.92%
3/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.92%
3/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.31%
1/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.92%
3/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Vascular disorders
Hypotension
|
0.92%
3/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.31%
1/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.2%
4/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
1.2%
4/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Gastrointestinal disorders
Ileus
|
0.62%
2/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.31%
1/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Infections and infestations
Infection
|
0.62%
2/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.94%
3/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Infections and infestations
Infective myositis
|
0.00%
0/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.31%
1/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
General disorders
Infusion related reaction
|
0.62%
2/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Investigations
International normalised ratio increased
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.31%
1/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Gastrointestinal disorders
Intestinal infarction
|
0.00%
0/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.31%
1/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Infections and infestations
Lobar pneumonia
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Infections and infestations
Localised infection
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Infections and infestations
Lung abscess
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.62%
2/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Infections and infestations
Lung infection
|
0.00%
0/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.31%
1/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.31%
1/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
4.6%
15/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
3.4%
11/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.92%
3/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.31%
1/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.31%
1/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
0.00%
0/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.31%
1/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
General disorders
Mucosal inflammation
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.31%
1/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.62%
2/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.31%
1/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Cardiac disorders
Myocardial infarction
|
1.2%
4/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.31%
1/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Gastrointestinal disorders
Nausea
|
1.5%
5/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.94%
3/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.31%
1/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
2.8%
9/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
1.2%
4/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
Other adverse events
| Measure |
Cetuximab+Taxane+Carboplatin
n=325 participants at risk
|
Taxane+Carboplatin
n=320 participants at risk
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
12.3%
40/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
8.4%
27/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
36.3%
118/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
44.1%
141/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Blood and lymphatic system disorders
Anaemia
|
8.0%
26/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
8.1%
26/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Metabolism and nutrition disorders
Anorexia
|
40.3%
131/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
30.3%
97/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Psychiatric disorders
Anxiety
|
9.8%
32/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
10.0%
32/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.7%
51/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
15.9%
51/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
General disorders
Asthenia
|
11.1%
36/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
6.6%
21/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.1%
49/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
12.8%
41/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.7%
25/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
7.8%
25/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
General disorders
Chills
|
7.7%
25/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
6.9%
22/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Psychiatric disorders
Confusional state
|
4.9%
16/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
5.0%
16/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Gastrointestinal disorders
Constipation
|
45.2%
147/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
30.9%
99/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
30.8%
100/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
25.3%
81/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
8.6%
28/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
6.2%
20/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Metabolism and nutrition disorders
Dehydration
|
24.3%
79/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
14.4%
46/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Psychiatric disorders
Depression
|
11.7%
38/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
8.8%
28/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
17.8%
58/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.62%
2/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Gastrointestinal disorders
Diarrhoea
|
48.0%
156/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
32.8%
105/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Nervous system disorders
Dizziness
|
20.6%
67/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
14.7%
47/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Gastrointestinal disorders
Dry mouth
|
5.5%
18/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
2.5%
8/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
20.9%
68/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
3.4%
11/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Nervous system disorders
Dysgeusia
|
18.5%
60/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
14.4%
46/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Gastrointestinal disorders
Dyspepsia
|
14.8%
48/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
9.1%
29/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Gastrointestinal disorders
Dysphagia
|
6.8%
22/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
3.8%
12/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
5.2%
17/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
2.8%
9/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
32.6%
106/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
32.5%
104/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.7%
38/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
5.6%
18/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
8.0%
26/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.31%
1/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
General disorders
Fatigue
|
74.8%
243/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
71.2%
228/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
5.8%
19/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
5.9%
19/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Nervous system disorders
Headache
|
11.1%
36/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
10.3%
33/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Immune system disorders
Hypersensitivity
|
6.8%
22/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
2.5%
8/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Nervous system disorders
Hypoaesthesia
|
6.2%
20/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
2.8%
9/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
9.5%
31/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.62%
2/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Vascular disorders
Hypotension
|
11.1%
36/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
5.9%
19/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Psychiatric disorders
Insomnia
|
26.5%
86/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
21.6%
69/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Infections and infestations
Localised infection
|
5.8%
19/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
0.00%
0/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
General disorders
Mucosal inflammation
|
15.4%
50/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
5.9%
19/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
8.9%
29/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
4.7%
15/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
7.7%
25/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
8.1%
26/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
13.8%
45/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
9.1%
29/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.2%
33/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
11.2%
36/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
5.2%
17/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
1.6%
5/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Gastrointestinal disorders
Nausea
|
60.9%
198/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
50.3%
161/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Nervous system disorders
Neuropathy peripheral
|
18.8%
61/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
20.0%
64/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Blood and lymphatic system disorders
Neutropenia
|
8.9%
29/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
5.9%
19/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
General disorders
Non-cardiac chest pain
|
9.5%
31/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
9.1%
29/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
General disorders
Oedema peripheral
|
16.9%
55/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
14.4%
46/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
13.8%
45/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
10.6%
34/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Nervous system disorders
Paraesthesia
|
5.8%
19/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
5.3%
17/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
13.2%
43/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
15.9%
51/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
13.8%
45/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
5.3%
17/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
General disorders
Pyrexia
|
13.2%
43/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
9.7%
31/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Skin and subcutaneous tissue disorders
Rash
|
57.2%
186/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
14.7%
47/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Gastrointestinal disorders
Stomatitis
|
22.2%
72/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
12.8%
41/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Cardiac disorders
Tachycardia
|
7.4%
24/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
1.9%
6/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.8%
22/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
4.1%
13/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Infections and infestations
Urinary tract infection
|
8.0%
26/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
4.1%
13/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Eye disorders
Vision blurred
|
6.5%
21/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
3.4%
11/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Gastrointestinal disorders
Vomiting
|
32.9%
107/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
29.1%
93/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
|
Investigations
Weight decreased
|
20.6%
67/325
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
10.3%
33/320
The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER