Trial Outcomes & Findings for Study of Patritumab in Combination With Erlotinib in Subjects With Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC). (HER3-Lung) (NCT NCT02134015)
NCT ID: NCT02134015
Last Updated: 2018-01-23
Results Overview
PFS is defined as the time from the date of randomization to the earlier of the dates of first objective documentation of radiographic disease progression (as per RECIST Version 1.1 per investigator assessment) or death resulting from any cause. Kaplan-Meier Estimate. Confidence interval (CI) for median was computed using the Brookmeyer-Crowley method. 80% confidence interval is included in the data table.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
145 participants
Primary outcome timeframe
by trial termination (at 20 months)
Results posted on
2018-01-23
Participant Flow
The first participant was randomized on 11 Jun 2014, and the last patient's last visit occurred on 11 Nov 2016. All randomized participants received study treatment and were included in both the Full Analysis Set and the Safety Analysis Set.
Of 537 patients screened, a total of 145 patients were randomized into this trial in 9 countries: United States (26 at 12 sites), Spain (19 at 5 sites), Hungary (18 at 4 sites), Italy (20 at 6 sites), Great Britain (11 at 5 sites), Poland (30 at 3 sites), Germany (16 at 6 sites), Canada (2 at 1 site) and Belgium (3 at 1 site).
Participant milestones
| Measure |
Placebo + Erlotinib
Placebo infusion every 3 weeks and oral erlotinib 150 mg/day
|
Patritumab + Erlotinib
Infusion of Patritumab (loading dose of 18 mg/kg, followed by 9 mg/kg every 3 weeks) and oral erlotinib 150 mg/day
|
|---|---|---|
|
Overall Study
STARTED
|
71
|
74
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
71
|
74
|
Reasons for withdrawal
| Measure |
Placebo + Erlotinib
Placebo infusion every 3 weeks and oral erlotinib 150 mg/day
|
Patritumab + Erlotinib
Infusion of Patritumab (loading dose of 18 mg/kg, followed by 9 mg/kg every 3 weeks) and oral erlotinib 150 mg/day
|
|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Death
|
2
|
1
|
|
Overall Study
Reason not provided
|
1
|
2
|
|
Overall Study
Clinical progression
|
14
|
7
|
|
Overall Study
Progressive disease (per RECIST 1.1)
|
40
|
43
|
|
Overall Study
Study terminated by sponsor
|
2
|
3
|
|
Overall Study
Adverse Event
|
9
|
10
|
|
Overall Study
Withdrawal by Subject
|
3
|
7
|
Baseline Characteristics
Study of Patritumab in Combination With Erlotinib in Subjects With Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC). (HER3-Lung)
Baseline characteristics by cohort
| Measure |
Placebo + Erlotinib
n=71 Participants
Placebo infusion every 3 weeks and oral erlotinib 150 mg/day
|
Patritumab + Erlotinib
n=74 Participants
Infusion of Patritumab (loading dose of 18 mg/kg, followed by 9 mg/kg every 3 weeks) and oral erlotinib 150 mg/day
|
Total
n=145 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
38 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
78 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
33 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
67 Participants
n=206 Participants
|
|
Age, Continuous
|
63.3 years
STANDARD_DEVIATION 9.15 • n=99 Participants
|
63.9 years
STANDARD_DEVIATION 8.25 • n=107 Participants
|
63.6 years
STANDARD_DEVIATION 8.68 • n=206 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
93 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
59 Participants
n=99 Participants
|
66 Participants
n=107 Participants
|
125 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
71 Participants
n=99 Participants
|
70 Participants
n=107 Participants
|
141 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Histology subtype
Adenocarcinoma
|
39 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
79 Participants
n=206 Participants
|
|
Histology subtype
Squamous
|
28 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
56 Participants
n=206 Participants
|
|
Histology subtype
Large Cell
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Histology subtype
Other
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Histology subtype (for randomization)
Adenocarcinoma
|
38 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
78 Participants
n=206 Participants
|
|
Histology subtype (for randomization)
Squamous-cell carcinoma/Not otherwise specified
|
33 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
67 Participants
n=206 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Score
0 - Fully Active
|
24 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Score
1 - Restricted in Physically Strenuous Activity
|
47 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
96 Participants
n=206 Participants
|
|
Heregulin (HRG) expression from Interactive Web/Voice Response System (IXRS)
HRG High
|
48 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
95 Participants
n=206 Participants
|
|
Heregulin (HRG) expression from Interactive Web/Voice Response System (IXRS)
HRG Low
|
23 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: by trial termination (at 20 months)PFS is defined as the time from the date of randomization to the earlier of the dates of first objective documentation of radiographic disease progression (as per RECIST Version 1.1 per investigator assessment) or death resulting from any cause. Kaplan-Meier Estimate. Confidence interval (CI) for median was computed using the Brookmeyer-Crowley method. 80% confidence interval is included in the data table.
Outcome measures
| Measure |
Placebo + Erlotinib
n=48 Participants
Placebo infusion every 3 weeks and oral erlotinib 150 mg/day
|
Patritumab + Erlotinib
n=47 Participants
Infusion of Patritumab (loading dose of 18 mg/kg, followed by 9 mg/kg every 3 weeks) and oral erlotinib 150 mg/day
|
|---|---|---|
|
Part A: Progression Free Survival (PFS) in Heregulin-high Participants
|
2.7 months
Interval 1.7 to 2.9
|
1.9 months
Interval 1.4 to 3.5
|
PRIMARY outcome
Timeframe: by trial termination (at 20 months)PFS is defined as the time from the date of randomization to the earlier of the dates of first objective documentation of radiographic disease progression (as per RECIST Version 1.1 per investigator assessment) or death resulting from any cause. Kaplan-Meier Estimate. Confidence interval (CI) for median was computed using the Brookmeyer-Crowley method. 80% confidence interval is included in the data table.
Outcome measures
| Measure |
Placebo + Erlotinib
n=23 Participants
Placebo infusion every 3 weeks and oral erlotinib 150 mg/day
|
Patritumab + Erlotinib
n=27 Participants
Infusion of Patritumab (loading dose of 18 mg/kg, followed by 9 mg/kg every 3 weeks) and oral erlotinib 150 mg/day
|
|---|---|---|
|
Part A: Progression Free Survival (PFS) in Heregulin-low Participants
|
2.8 months
Interval 1.4 to 4.2
|
1.5 months
Interval 1.4 to 2.7
|
PRIMARY outcome
Timeframe: 4 yearsPopulation: No participants were analyzed for Part B endpoints because the trial was terminated at the end of Part A.
Percentage of participants still alive at the end of Part B
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: by trial termination (at 20 months)Key secondary efficacy endpoint: Percentage of participants who survived for the length of the trial
Outcome measures
| Measure |
Placebo + Erlotinib
n=48 Participants
Placebo infusion every 3 weeks and oral erlotinib 150 mg/day
|
Patritumab + Erlotinib
n=47 Participants
Infusion of Patritumab (loading dose of 18 mg/kg, followed by 9 mg/kg every 3 weeks) and oral erlotinib 150 mg/day
|
|---|---|---|
|
Part A: Overall Survival in HRG High Participants
|
15 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: by trial termination (at 20 months)Key secondary efficacy endpoint: Percentage of participants who survived for the length of the trial
Outcome measures
| Measure |
Placebo + Erlotinib
n=23 Participants
Placebo infusion every 3 weeks and oral erlotinib 150 mg/day
|
Patritumab + Erlotinib
n=27 Participants
Infusion of Patritumab (loading dose of 18 mg/kg, followed by 9 mg/kg every 3 weeks) and oral erlotinib 150 mg/day
|
|---|---|---|
|
Part A: Key Secondary Efficacy Endpoint: Overall Survival in HRG Low Participants
|
7 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 4 yearsPopulation: No participants were analyzed for Part B endpoints because the trial was terminated at the end of Part A.
PFS is defined as the time from the date of randomization to the earlier of the dates of first objective documentation of radiographic disease progression (TTD, as per RECIST Version 1.1 per investigator assessment) or death resulting from any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: by trial termination (at 20 months)Population: Evaluable participants in the full analysis set
Key secondary efficacy endpoint: Objective response is defined as percentage of participants achieving complete response (CR) or partial response (PR) Denominator for percentages is the number of subjects with measurable disease in the full analysis set. The best overall response is the best response \[in the order of CR, PR, stable disease (SD), and progressive disease (PD)\] among all overall responses recorded from the start of treatment until the subject withdraws from the study. If there is no post-baseline tumor assessment or all post-baseline tumor assessments with overall response being Inevaluable captured in the CRF, the best overall response is classified as Inevaluable.
Outcome measures
| Measure |
Placebo + Erlotinib
n=48 Participants
Placebo infusion every 3 weeks and oral erlotinib 150 mg/day
|
Patritumab + Erlotinib
n=46 Participants
Infusion of Patritumab (loading dose of 18 mg/kg, followed by 9 mg/kg every 3 weeks) and oral erlotinib 150 mg/day
|
|---|---|---|
|
Part A: Objective Response Rate (ORR) in HRG High Participants
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: by trial termination (at 20 months)Population: Evaluable participants in the full analysis set
Key secondary efficacy endpoint: Objective response is defined as percentage of participants achieving complete response or partial response Denominator for percentages is the number of subjects with measurable disease in the full analysis set. The best overall response is the best response (in the order of CR, PR, SD, and PD) among all overall responses recorded from the start of treatment until the subject withdraws from the study. If there is no post-baseline tumor assessment or all post-baseline tumor assessments with overall response being Inevaluable captured in the CRF, the best overall response is classified as Inevaluable.
Outcome measures
| Measure |
Placebo + Erlotinib
n=22 Participants
Placebo infusion every 3 weeks and oral erlotinib 150 mg/day
|
Patritumab + Erlotinib
n=27 Participants
Infusion of Patritumab (loading dose of 18 mg/kg, followed by 9 mg/kg every 3 weeks) and oral erlotinib 150 mg/day
|
|---|---|---|
|
Part A: Objective Response Rate (ORR) in HRG Low Participants
|
3 Participants
|
1 Participants
|
Adverse Events
Placebo + Erlotinib
Serious events: 29 serious events
Other events: 66 other events
Deaths: 5 deaths
Patritumab + Erlotinib
Serious events: 27 serious events
Other events: 68 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Placebo + Erlotinib
n=71 participants at risk
Placebo infusion every 3 weeks and oral erlotinib 150 mg/day
|
Patritumab + Erlotinib
n=74 participants at risk
Infusion of Patritumab (loading dose of 18 mg/kg, followed by 9 mg/kg every 3 weeks) and oral erlotinib 150 mg/day
|
|---|---|---|
|
Vascular disorders
Deep vein thrombosis
|
1.4%
1/71 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
1.4%
1/74 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
1.4%
1/71 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
0.00%
0/74 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
1.4%
1/71 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
0.00%
0/74 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
General disorders
General physical health deterioration
|
1.4%
1/71 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
2.7%
2/74 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
General disorders
Asthenia
|
1.4%
1/71 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
0.00%
0/74 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
General disorders
Pain
|
0.00%
0/71 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
1.4%
1/74 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/71 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
1.4%
1/74 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/71 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
1.4%
1/74 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/71 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
1.4%
1/74 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/71 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
1.4%
1/74 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/71 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
1.4%
1/74 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/71 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
1.4%
1/74 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Investigations
Transaminases increased
|
1.4%
1/71 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
0.00%
0/74 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Cardiac disorders
Cardiac failure
|
1.4%
1/71 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
0.00%
0/74 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/71 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
1.4%
1/74 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/71 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
1.4%
1/74 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/71 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
1.4%
1/74 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.2%
3/71 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
6.8%
5/74 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/71 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
2.7%
2/74 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.4%
1/71 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
2.7%
2/74 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.4%
1/71 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
0.00%
0/74 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.4%
1/71 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
0.00%
0/74 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Respiratory, thoracic and mediastinal disorders
Hydropneumothorax
|
0.00%
0/71 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
1.4%
1/74 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.4%
1/71 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
1.4%
1/74 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.4%
1/71 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
0.00%
0/74 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.4%
1/71 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
1.4%
1/74 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.4%
1/71 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
1.4%
1/74 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
1.4%
1/71 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
0.00%
0/74 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/71 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
1.4%
1/74 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.4%
1/71 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
0.00%
0/74 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Nervous system disorders
Dizziness
|
1.4%
1/71 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
0.00%
0/74 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Nervous system disorders
Headache
|
0.00%
0/71 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
1.4%
1/74 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/71 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
1.4%
1/74 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/71 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
2.7%
2/74 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Gastrointestinal disorders
Aphagia
|
1.4%
1/71 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
0.00%
0/74 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Gastrointestinal disorders
Dysphagia
|
1.4%
1/71 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
0.00%
0/74 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/71 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
1.4%
1/74 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Gastrointestinal disorders
Swollen tongue
|
0.00%
0/71 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
1.4%
1/74 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Hepatobiliary disorders
Cholecystitis
|
1.4%
1/71 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
0.00%
0/74 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.4%
1/71 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
0.00%
0/74 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
1.4%
1/71 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
0.00%
0/74 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/71 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
1.4%
1/74 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.4%
1/71 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
0.00%
0/74 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.4%
1/71 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
1.4%
1/74 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/71 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
1.4%
1/74 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Infections and infestations
Pneumonia
|
4.2%
3/71 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
1.4%
1/74 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Infections and infestations
Bronchitis
|
1.4%
1/71 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
0.00%
0/74 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Infections and infestations
Empyema
|
1.4%
1/71 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
0.00%
0/74 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Infections and infestations
Lung abscess
|
1.4%
1/71 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
0.00%
0/74 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/71 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
1.4%
1/74 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Infections and infestations
Respiratory tract infection
|
1.4%
1/71 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
0.00%
0/74 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/71 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
1.4%
1/74 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
Other adverse events
| Measure |
Placebo + Erlotinib
n=71 participants at risk
Placebo infusion every 3 weeks and oral erlotinib 150 mg/day
|
Patritumab + Erlotinib
n=74 participants at risk
Infusion of Patritumab (loading dose of 18 mg/kg, followed by 9 mg/kg every 3 weeks) and oral erlotinib 150 mg/day
|
|---|---|---|
|
Vascular disorders
Pruritus
|
5.6%
4/71 • Number of events 6 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
8.1%
6/74 • Number of events 7 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Investigations
Weight decreased
|
11.3%
8/71 • Number of events 9 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
13.5%
10/74 • Number of events 11 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Blood and lymphatic system disorders
Anaemia
|
5.6%
4/71 • Number of events 5 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
8.1%
6/74 • Number of events 10 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
22.5%
16/71 • Number of events 21 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
12.2%
9/74 • Number of events 11 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.5%
11/71 • Number of events 11 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
13.5%
10/74 • Number of events 14 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
7.0%
5/71 • Number of events 7 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
6.8%
5/74 • Number of events 7 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/71 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
5.4%
4/74 • Number of events 4 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Nervous system disorders
Dizziness
|
7.0%
5/71 • Number of events 5 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
0.00%
0/74 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Nervous system disorders
Dysgeusia
|
4.2%
3/71 • Number of events 3 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
5.4%
4/74 • Number of events 4 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
General disorders
Fatigue
|
23.9%
17/71 • Number of events 23 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
14.9%
11/74 • Number of events 12 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
General disorders
Oedema peripheral
|
8.5%
6/71 • Number of events 6 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
6.8%
5/74 • Number of events 5 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
General disorders
Asthenia
|
7.0%
5/71 • Number of events 6 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
6.8%
5/74 • Number of events 5 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
General disorders
Chest pain
|
5.6%
4/71 • Number of events 5 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
2.7%
2/74 • Number of events 2 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Psychiatric disorders
Insomnia
|
4.2%
3/71 • Number of events 3 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
5.4%
4/74 • Number of events 4 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Gastrointestinal disorders
Diarrhoea
|
31.0%
22/71 • Number of events 41 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
52.7%
39/74 • Number of events 62 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Gastrointestinal disorders
Nausea
|
22.5%
16/71 • Number of events 18 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
20.3%
15/74 • Number of events 19 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Gastrointestinal disorders
Stomatitis
|
2.8%
2/71 • Number of events 2 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
14.9%
11/74 • Number of events 18 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Gastrointestinal disorders
Vomiting
|
9.9%
7/71 • Number of events 8 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
13.5%
10/74 • Number of events 13 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Gastrointestinal disorders
Constipation
|
2.8%
2/71 • Number of events 2 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
12.2%
9/74 • Number of events 9 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Gastrointestinal disorders
Dyspepsia
|
4.2%
3/71 • Number of events 3 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
6.8%
5/74 • Number of events 7 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Skin and subcutaneous tissue disorders
Rash
|
36.6%
26/71 • Number of events 46 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
37.8%
28/74 • Number of events 57 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
8.5%
6/71 • Number of events 7 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
17.6%
13/74 • Number of events 23 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
9.9%
7/71 • Number of events 7 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
17.6%
13/74 • Number of events 14 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.2%
3/71 • Number of events 4 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
8.1%
6/74 • Number of events 6 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.6%
4/71 • Number of events 4 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
4.1%
3/74 • Number of events 5 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
18.3%
13/71 • Number of events 16 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
23.0%
17/74 • Number of events 21 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
5.6%
4/71 • Number of events 7 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
9.5%
7/74 • Number of events 17 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.4%
1/71 • Number of events 1 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
8.1%
6/74 • Number of events 6 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.4%
1/71 • Number of events 1 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
5.4%
4/74 • Number of events 4 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Infections and infestations
Paronychia
|
4.2%
3/71 • Number of events 4 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
9.5%
7/74 • Number of events 16 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/71 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
5.4%
4/74 • Number of events 4 • 53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later (within the length of the trial, which was 2 years, 7 months)
Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place