Trial Outcomes & Findings for A Study of the Combination of Erlotinib and Pertuzumab in Patients With Relapsed Non-small Cell Lung Cancer (NCT NCT00855894)
NCT ID: NCT00855894
Last Updated: 2013-05-21
Results Overview
The assessment of FDG-PET response was performed by a central reading site. PET response was based on the maximum standard uptake value (SUVmax) of up to 5 regions of interest (ROI). The tumor ROIs were identified for each patient on pretreatment FDG-PET scans and corresponded to a subset of the target lesions identified for Response Evaluation Criteria for Solid Tumors (RECIST) analysis. Specifically, the SUVmax of each ROI on the on-treatment scans was compared with the SUVmax on the corresponding pretreatment scan and the percent change was calculated. When there was more than 1 ROI, the overall percent change in SUVmax was the arithmetic mean of the percent changes in SUVmax for each of the ROIs (mSUVmax). An PET response is defined as a decrease of ≥ 20% in mSUVmax. EGFR mutation status was assessed in tumor tissue samples taken from each patient.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
Baseline to Day 56
Results posted on
2013-05-21
Participant Flow
Patients were considered to have completed the study if they were alive at their last survival follow-up visit prior to 10 Nov 2011, which was 1 year after the last patient was enrolled, or they were continuing treatment per Amendment 3 of the study protocol (1 patient).
Participant milestones
| Measure |
Pertuzumab + Erlotinib
Patients received pertuzumab 840 mg intravenously (IV) 1 time (loading dose) followed by 420 mg IV (maintenance dose) every 3 weeks (q3w) plus erlotinib 150 mg orally once a day which was reduced to 100 mg orally once a day in a protocol amendment dated 19 May 2010.
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|---|---|
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Overall Study
STARTED
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41
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Overall Study
COMPLETED
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8
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Overall Study
NOT COMPLETED
|
33
|
Reasons for withdrawal
| Measure |
Pertuzumab + Erlotinib
Patients received pertuzumab 840 mg intravenously (IV) 1 time (loading dose) followed by 420 mg IV (maintenance dose) every 3 weeks (q3w) plus erlotinib 150 mg orally once a day which was reduced to 100 mg orally once a day in a protocol amendment dated 19 May 2010.
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|---|---|
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Overall Study
Death
|
31
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Overall Study
Patient's decision
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1
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Overall Study
Disease progression
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1
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Baseline Characteristics
A Study of the Combination of Erlotinib and Pertuzumab in Patients With Relapsed Non-small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Pertuzumab + Erlotinib
n=41 Participants
Patients received pertuzumab 840 mg intravenously (IV) 1 time (loading dose) followed by 420 mg IV (maintenance dose) every 3 weeks (q3w) plus erlotinib 150 mg orally once a day which was reduced to 100 mg orally once a day in a protocol amendment dated 19 May 2010.
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|---|---|
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Age Continuous
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60.7 years
STANDARD_DEVIATION 8.3 • n=99 Participants
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Sex: Female, Male
Female
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17 Participants
n=99 Participants
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Sex: Female, Male
Male
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24 Participants
n=99 Participants
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PRIMARY outcome
Timeframe: Baseline to Day 56Population: All 41 patients treated with pertuzumab and erlotinib were evaluable for analysis. Patients with a missing Day 56 assessment were deemed non-responders. Tumor tissue samples were only available for 32 patients for EGFR mutation status analysis.
The assessment of FDG-PET response was performed by a central reading site. PET response was based on the maximum standard uptake value (SUVmax) of up to 5 regions of interest (ROI). The tumor ROIs were identified for each patient on pretreatment FDG-PET scans and corresponded to a subset of the target lesions identified for Response Evaluation Criteria for Solid Tumors (RECIST) analysis. Specifically, the SUVmax of each ROI on the on-treatment scans was compared with the SUVmax on the corresponding pretreatment scan and the percent change was calculated. When there was more than 1 ROI, the overall percent change in SUVmax was the arithmetic mean of the percent changes in SUVmax for each of the ROIs (mSUVmax). An PET response is defined as a decrease of ≥ 20% in mSUVmax. EGFR mutation status was assessed in tumor tissue samples taken from each patient.
Outcome measures
| Measure |
Pertuzumab + Erlotinib
n=41 Participants
Patients received pertuzumab 840 mg intravenously (IV) 1 time (loading dose) followed by 420 mg IV (maintenance dose) every 3 weeks (q3w) plus erlotinib 150 mg orally once a day which was reduced to 100 mg orally once a day in a protocol amendment dated 19 May 2010.
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|---|---|
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Percentage of Patients With a 2-deoxy-2-[18F]Fluoro-D-glucose-positron Emission Tomography (FDG-PET) Response at Day 56 in All Patients and in Epidermal Growth Factor Receptor (EGFR) Mutant and Wild-type Subgroups
In all patients
|
19.5 Percentage of patients
Interval 9.2 to 33.9
|
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Percentage of Patients With a 2-deoxy-2-[18F]Fluoro-D-glucose-positron Emission Tomography (FDG-PET) Response at Day 56 in All Patients and in Epidermal Growth Factor Receptor (EGFR) Mutant and Wild-type Subgroups
In patients with EGFR mutation(s), n=9
|
66.7 Percentage of patients
Interval 29.9 to 90.2
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Percentage of Patients With a 2-deoxy-2-[18F]Fluoro-D-glucose-positron Emission Tomography (FDG-PET) Response at Day 56 in All Patients and in Epidermal Growth Factor Receptor (EGFR) Mutant and Wild-type Subgroups
In patients with wild-type EGFR, n=23
|
8.7 Percentage of patients
Interval 1.6 to 26.8
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SECONDARY outcome
Timeframe: Baseline to the end of the study (up to 3 years)Population: All 41 patients treated with erlotinib and pertuzumab. Patients who had not progressed or died at the time of analysis for PFS were censored at the date of their last tumor assessment.
PFS was defined as the time from the first dosing with pertuzumab and erlotinib to the first occurrence of disease progression (PD), as determined by the investigator and based on computed tomography using Response Evaluation Criteria in Solid Tumors (RECIST), or death from any cause, whichever comes first. PD was defined as ≥ 20% increase in the sum of the longest diameter of target lesions (TL), taking as reference the smallest sum longest diameter recorded since treatment started, the unequivocal progression of existing non-target lesions (non-TL), or the appearance of 1 or more new lesions. TLs were selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements by imaging techniques or clinically. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, were identified as TLs. All other lesions (or sites of disease) were identified as non-TLs.
Outcome measures
| Measure |
Pertuzumab + Erlotinib
n=41 Participants
Patients received pertuzumab 840 mg intravenously (IV) 1 time (loading dose) followed by 420 mg IV (maintenance dose) every 3 weeks (q3w) plus erlotinib 150 mg orally once a day which was reduced to 100 mg orally once a day in a protocol amendment dated 19 May 2010.
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|---|---|
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Progression-free Survival (PFS)
|
1.9 Months
Interval 1.87 to 3.38
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SECONDARY outcome
Timeframe: Baseline to the end of the study (up to 3 years)Population: All 41 patients treated with erlotinib and pertuzumab. Patients who had not died at the time of analysis for OS were censored at the date of last contact.
Overall survival was defined as the time from the date of first dosing with pertuzumab and erlotinib until the date of patient death from any cause.
Outcome measures
| Measure |
Pertuzumab + Erlotinib
n=41 Participants
Patients received pertuzumab 840 mg intravenously (IV) 1 time (loading dose) followed by 420 mg IV (maintenance dose) every 3 weeks (q3w) plus erlotinib 150 mg orally once a day which was reduced to 100 mg orally once a day in a protocol amendment dated 19 May 2010.
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|---|---|
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Overall Survival (OS)
|
8.7 Months
Interval 4.7 to 9.99
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SECONDARY outcome
Timeframe: Baseline to the end of the study (up to 3 years)Population: All 41 patients treated with erlotinib and pertuzumab.
OR was defined as a complete response (CR) or a partial response (PR) as determined by the investigator and based on computed tomography (CT) using Response Evaluation Criteria in Solid Tumors (RECIST) on 2 consecutive occasions at least 4 weeks apart. A complete response was defined as the disappearance of all target and non-target lesions and normalization of tumor marker level. A partial response was defined as ≥ 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter, or the persistence of 1 or more non-target lesions and/or the maintenance of a tumor marker level above the normal limits.
Outcome measures
| Measure |
Pertuzumab + Erlotinib
n=41 Participants
Patients received pertuzumab 840 mg intravenously (IV) 1 time (loading dose) followed by 420 mg IV (maintenance dose) every 3 weeks (q3w) plus erlotinib 150 mg orally once a day which was reduced to 100 mg orally once a day in a protocol amendment dated 19 May 2010.
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|---|---|
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Percentage of Patients With an Objective Response (OR)
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7.3 Percentage of patients
Interval 2.0 to 19.0
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SECONDARY outcome
Timeframe: Baseline to Day 56Population: All 41 patients treated with erlotinib and pertuzumab.
DC was defined as a CR, a PR, or stable disease (SD) as determined by the investigator and based on CT using RECIST. A CR was defined as the disappearance of all target (TL) and non-target lesions (nTL). A PR was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline sum longest diameter, or the persistence of 1 or more nTLs and/or maintenance of a tumor marker level (TML) above normal limits. For TLs, SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum longest diameter (SSLD) since treatment started. For nTLs, SD was defined as the persistence of 1 or more lesions and/or maintenance of a TML above normal limits. PD was defined as ≥ 20% increase in the SLD of TLs, taking as reference the SSLD recorded since treatment started, the appearance of 1 or more new lesions, or the unequivocal progression of existing nTLs.
Outcome measures
| Measure |
Pertuzumab + Erlotinib
n=41 Participants
Patients received pertuzumab 840 mg intravenously (IV) 1 time (loading dose) followed by 420 mg IV (maintenance dose) every 3 weeks (q3w) plus erlotinib 150 mg orally once a day which was reduced to 100 mg orally once a day in a protocol amendment dated 19 May 2010.
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|---|---|
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Percentage of Patients With Disease Control (DC) at Day 56
|
31.7 Percentage of patients
Interval 19.0 to 46.9
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Adverse Events
Pertuzumab + Erlotinib
Serious events: 18 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pertuzumab + Erlotinib
n=41 participants at risk
Patients received pertuzumab 840 mg intravenously (IV) 1 time (loading dose) followed by 420 mg IV (maintenance dose) every 3 weeks (q3w) plus erlotinib 150 mg orally once a day which was reduced to 100 mg orally once a day in a protocol amendment dated 19 May 2010.
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|---|---|
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Blood and lymphatic system disorders
Anaemia
|
2.4%
1/41 • Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse events are reported for all patients who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Left ventricular dysfunction
|
2.4%
1/41 • Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse events are reported for all patients who received at least 1 dose of study treatment.
|
|
Endocrine disorders
Adrenal insufficiency
|
2.4%
1/41 • Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse events are reported for all patients who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
12.2%
5/41 • Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse events are reported for all patients who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
9.8%
4/41 • Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse events are reported for all patients who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Pneumatosis intestinalis
|
7.3%
3/41 • Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse events are reported for all patients who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
2.4%
1/41 • Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse events are reported for all patients who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
2.4%
1/41 • Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse events are reported for all patients who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Pancreatitis
|
2.4%
1/41 • Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse events are reported for all patients who received at least 1 dose of study treatment.
|
|
General disorders
Oedema peripheral
|
2.4%
1/41 • Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse events are reported for all patients who received at least 1 dose of study treatment.
|
|
General disorders
Pyrexia
|
2.4%
1/41 • Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse events are reported for all patients who received at least 1 dose of study treatment.
|
|
Infections and infestations
Infection
|
2.4%
1/41 • Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse events are reported for all patients who received at least 1 dose of study treatment.
|
|
Infections and infestations
Pharyngeal abscess
|
2.4%
1/41 • Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse events are reported for all patients who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
4.9%
2/41 • Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse events are reported for all patients who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.4%
1/41 • Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse events are reported for all patients who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor invasion
|
2.4%
1/41 • Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse events are reported for all patients who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Cerebral haemorrhage
|
2.4%
1/41 • Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse events are reported for all patients who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Sedation
|
2.4%
1/41 • Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse events are reported for all patients who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Renal failure acute
|
2.4%
1/41 • Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse events are reported for all patients who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.4%
1/41 • Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse events are reported for all patients who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
2.4%
1/41 • Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse events are reported for all patients who received at least 1 dose of study treatment.
|
|
Vascular disorders
Orthostatic hypotension
|
2.4%
1/41 • Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse events are reported for all patients who received at least 1 dose of study treatment.
|
Other adverse events
| Measure |
Pertuzumab + Erlotinib
n=41 participants at risk
Patients received pertuzumab 840 mg intravenously (IV) 1 time (loading dose) followed by 420 mg IV (maintenance dose) every 3 weeks (q3w) plus erlotinib 150 mg orally once a day which was reduced to 100 mg orally once a day in a protocol amendment dated 19 May 2010.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
7.3%
3/41 • Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse events are reported for all patients who received at least 1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
7.3%
3/41 • Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse events are reported for all patients who received at least 1 dose of study treatment.
|
|
Eye disorders
Dry eye
|
17.1%
7/41 • Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse events are reported for all patients who received at least 1 dose of study treatment.
|
|
Eye disorders
Conjunctivitis
|
14.6%
6/41 • Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse events are reported for all patients who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
87.8%
36/41 • Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse events are reported for all patients who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
61.0%
25/41 • Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse events are reported for all patients who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
51.2%
21/41 • Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse events are reported for all patients who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
17.1%
7/41 • Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse events are reported for all patients who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
14.6%
6/41 • Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse events are reported for all patients who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
12.2%
5/41 • Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse events are reported for all patients who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
12.2%
5/41 • Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse events are reported for all patients who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.3%
3/41 • Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse events are reported for all patients who received at least 1 dose of study treatment.
|
|
General disorders
Fatigue
|
68.3%
28/41 • Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse events are reported for all patients who received at least 1 dose of study treatment.
|
|
General disorders
Mucosal infalmmation
|
53.7%
22/41 • Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse events are reported for all patients who received at least 1 dose of study treatment.
|
|
General disorders
Oedema peripheral
|
12.2%
5/41 • Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse events are reported for all patients who received at least 1 dose of study treatment.
|
|
General disorders
Chest pain
|
7.3%
3/41 • Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse events are reported for all patients who received at least 1 dose of study treatment.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
7.3%
3/41 • Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse events are reported for all patients who received at least 1 dose of study treatment.
|
|
Infections and infestations
Paronychia
|
24.4%
10/41 • Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse events are reported for all patients who received at least 1 dose of study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.3%
3/41 • Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse events are reported for all patients who received at least 1 dose of study treatment.
|
|
Investigations
Weight decreased
|
22.0%
9/41 • Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse events are reported for all patients who received at least 1 dose of study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
7.3%
3/41 • Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse events are reported for all patients who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
63.4%
26/41 • Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse events are reported for all patients who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
24.4%
10/41 • Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse events are reported for all patients who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
22.0%
9/41 • Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse events are reported for all patients who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
19.5%
8/41 • Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse events are reported for all patients who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypoalbumaemia
|
9.8%
4/41 • Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse events are reported for all patients who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
7.3%
3/41 • Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse events are reported for all patients who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
7.3%
3/41 • Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse events are reported for all patients who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.3%
3/41 • Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse events are reported for all patients who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Dysgeusia
|
22.0%
9/41 • Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse events are reported for all patients who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Dizziness
|
9.8%
4/41 • Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse events are reported for all patients who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Headache
|
7.3%
3/41 • Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse events are reported for all patients who received at least 1 dose of study treatment.
|
|
Psychiatric disorders
Depression
|
12.2%
5/41 • Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse events are reported for all patients who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
26.8%
11/41 • Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse events are reported for all patients who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
14.6%
6/41 • Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse events are reported for all patients who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
12.2%
5/41 • Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse events are reported for all patients who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
63.4%
26/41 • Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse events are reported for all patients who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
22.0%
9/41 • Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse events are reported for all patients who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
22.0%
9/41 • Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse events are reported for all patients who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
12.2%
5/41 • Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse events are reported for all patients who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.2%
5/41 • Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse events are reported for all patients who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
7.3%
3/41 • Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse events are reported for all patients who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
7.3%
3/41 • Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse events are reported for all patients who received at least 1 dose of study treatment.
|
Additional Information
Medical Communications
Genentech, Inc.
Phone: 800 821-8590
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER