Trial Outcomes & Findings for A Study of Induction and Maintenance Treatment of Advanced or Metastatic Non Squamous Non-Small Cell Lung Cancer (NCT NCT00867009)
NCT ID: NCT00867009
Last Updated: 2015-06-15
Results Overview
Response was assessed using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions. Tumor response is presented as a percentage (%) and is the number of participants with a CR plus PR divided by the number of participants in the protocol qualified (PQ) population, then multiplied by 100.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
113 participants
Primary outcome timeframe
From start of treatment until documented best response. (up to 18.9 months)
Results posted on
2015-06-15
Participant Flow
Participant milestones
| Measure |
Pem/Cis + Cet
Induction Therapy: 500 mg/m² pemetrexed (Pem)on Day 1 of every 21-day cycle, 75 mg/m² cisplatin (Cis) on Day 1 of every 21-day cycle and 400 mg/m² cetuximab (Cet) given intravenously (IV) on Day 1 of Cycle 1 and 250 mg/m² once weekly thereafter. Induction period is 4 to 6 cycles.
Maintenance Therapy: 500 mg/m² pemetrexed (Pem) given intravenously (IV) on Day 1 of each 21 day cycle and 250 mg/m² cetuximab (Cet) given weekly until progressive disease (PD) or treatment discontinuation.
|
|---|---|
|
Induction Period
STARTED
|
113
|
|
Induction Period
Received at Least 1 Dose of Study Drug
|
113
|
|
Induction Period
Protocol Qualified (PQ) Population
|
109
|
|
Induction Period
COMPLETED
|
51
|
|
Induction Period
NOT COMPLETED
|
62
|
|
Maintenance Period
STARTED
|
51
|
|
Maintenance Period
COMPLETED
|
47
|
|
Maintenance Period
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Pem/Cis + Cet
Induction Therapy: 500 mg/m² pemetrexed (Pem)on Day 1 of every 21-day cycle, 75 mg/m² cisplatin (Cis) on Day 1 of every 21-day cycle and 400 mg/m² cetuximab (Cet) given intravenously (IV) on Day 1 of Cycle 1 and 250 mg/m² once weekly thereafter. Induction period is 4 to 6 cycles.
Maintenance Therapy: 500 mg/m² pemetrexed (Pem) given intravenously (IV) on Day 1 of each 21 day cycle and 250 mg/m² cetuximab (Cet) given weekly until progressive disease (PD) or treatment discontinuation.
|
|---|---|
|
Induction Period
Nonserious Adverse Event
|
5
|
|
Induction Period
Serious Adverse Event
|
10
|
|
Induction Period
Death due to serious adverse event
|
6
|
|
Induction Period
Death due to Study Disease
|
4
|
|
Induction Period
Protocol Violation
|
1
|
|
Induction Period
Withdrawal by Subject
|
8
|
|
Induction Period
Physician Decision
|
3
|
|
Induction Period
Progressive Disease (PD)
|
25
|
|
Maintenance Period
On-going in the Study at Data Cut-off
|
4
|
Baseline Characteristics
A Study of Induction and Maintenance Treatment of Advanced or Metastatic Non Squamous Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Pem/Cis + Cet
n=113 Participants
Induction Therapy: 500 mg/m² pemetrexed (Pem)on Day 1 of every 21-day cycle, 75 mg/m² cisplatin (Cis) on Day 1 of every 21-day cycle and 400 mg/m² cetuximab (Cet) given intravenously (IV) on Day 1 of Cycle 1 and 250 mg/m² once weekly thereafter. Induction period is 4 to 6 cycles.
Maintenance Therapy: 500 mg/m² pemetrexed (Pem) given intravenously (IV) on Day 1 of each 21 day cycle and 250 mg/m² cetuximab (Cet) given weekly until progressive disease (PD) or treatment discontinuation.
|
|---|---|
|
Age, Continuous
|
59.15 years
STANDARD_DEVIATION 8.83 • n=5 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
72 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
113 participants
n=5 Participants
|
|
Region of Enrollment
Greece
|
12 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
25 participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
6 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
28 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
16 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
26 participants
n=5 Participants
|
|
Eastern Co-operative Oncology Group (ECOG) Performance Status
0 - Fully Active
|
56 participants
n=5 Participants
|
|
Eastern Co-operative Oncology Group (ECOG) Performance Status
1 - Ambulatory, Restricted Strenuous Activity
|
57 participants
n=5 Participants
|
|
Disease Stage
Stage IIIB
|
9 participants
n=5 Participants
|
|
Disease Stage
Stage IV
|
104 participants
n=5 Participants
|
|
Pathological Diagnosis
Adenocarcinoma (Adeno), Breast
|
1 participants
n=5 Participants
|
|
Pathological Diagnosis
Carcinoma, Adenosquamous,Lung, Predominantly Adeno
|
1 participants
n=5 Participants
|
|
Pathological Diagnosis
Large Cells Lung Carcinoma
|
5 participants
n=5 Participants
|
|
Pathological Diagnosis
Malignant Neoplasm, Adeno Lung
|
88 participants
n=5 Participants
|
|
Pathological Diagnosis
Non-Small Cell Lung (NSCL) Cancer
|
9 participants
n=5 Participants
|
|
Pathological Diagnosis
Poorly Differentiated Non-Small Cell
|
8 participants
n=5 Participants
|
|
Pathological Diagnosis
Missing
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From start of treatment until documented best response. (up to 18.9 months)Population: Outcome measure was assessed using the Protocol Qualified (PQ) population.
Response was assessed using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions. Tumor response is presented as a percentage (%) and is the number of participants with a CR plus PR divided by the number of participants in the protocol qualified (PQ) population, then multiplied by 100.
Outcome measures
| Measure |
Pem/Cis + Cet
n=109 Participants
Induction Therapy: 500 mg/m² pemetrexed (Pem)on Day 1 of every 21-day cycle, 75 mg/m² cisplatin (Cis) on Day 1 of every 21-day cycle and 400 mg/m² cetuximab (Cet) given intravenously (IV) on Day 1 of Cycle 1 and 250 mg/m² once weekly thereafter. Induction period is 4 to 6 cycles.
Maintenance Therapy: 500 mg/m² pemetrexed (Pem) given intravenously (IV) on Day 1 of each 21 day cycle and 250 mg/m² cetuximab (Cet) given weekly until progressive disease (PD) or treatment discontinuation.
|
|---|---|
|
Percentage of Participants With a Tumor Response (Objective Tumor Response Rate)
|
38.5 percentage of participants
|
SECONDARY outcome
Timeframe: From start of treatment until documented disease progression or death from any cause (up to 18.9 months)Population: Outcome measure was assessed using the Protocol Qualified (PQ) population.
PFS is measured from study entry until disease progression, death or date of last contact. Progressive disease (PD) was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD = 20% increase in sum of longest diameter of target lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. For participants not known to have died or have had objective PD as of the data cutoff date, PFS was censored at the date of the last objective progression-free disease assessment.
Outcome measures
| Measure |
Pem/Cis + Cet
n=109 Participants
Induction Therapy: 500 mg/m² pemetrexed (Pem)on Day 1 of every 21-day cycle, 75 mg/m² cisplatin (Cis) on Day 1 of every 21-day cycle and 400 mg/m² cetuximab (Cet) given intravenously (IV) on Day 1 of Cycle 1 and 250 mg/m² once weekly thereafter. Induction period is 4 to 6 cycles.
Maintenance Therapy: 500 mg/m² pemetrexed (Pem) given intravenously (IV) on Day 1 of each 21 day cycle and 250 mg/m² cetuximab (Cet) given weekly until progressive disease (PD) or treatment discontinuation.
|
|---|---|
|
Progression-free Survival (PFS)
|
5.82 months
Interval 0.03 to 18.89
|
SECONDARY outcome
Timeframe: One yearPopulation: Outcome measure was assessed using the Protocol Qualified (PQ) population.
The one year survival rate is presented as percentage (%) of participants still living at one year and is the number of participants that are still alive at one year divided by the number of participants in the protocol qualified (PQ) population, which is then multiplied by 100.
Outcome measures
| Measure |
Pem/Cis + Cet
n=109 Participants
Induction Therapy: 500 mg/m² pemetrexed (Pem)on Day 1 of every 21-day cycle, 75 mg/m² cisplatin (Cis) on Day 1 of every 21-day cycle and 400 mg/m² cetuximab (Cet) given intravenously (IV) on Day 1 of Cycle 1 and 250 mg/m² once weekly thereafter. Induction period is 4 to 6 cycles.
Maintenance Therapy: 500 mg/m² pemetrexed (Pem) given intravenously (IV) on Day 1 of each 21 day cycle and 250 mg/m² cetuximab (Cet) given weekly until progressive disease (PD) or treatment discontinuation.
|
|---|---|
|
The Percentage of Participants Still Living at One Year (One Year Survival Rate)
|
45 percentage of participants
|
SECONDARY outcome
Timeframe: From start of treatment until documented best tumor response (up to 18.9 months)Population: Outcome measure was assessed using the Protocol Qualified (PQ) population.
The DCR is presented as percentage (%) and is the number of participants with a best tumor response of CR, PR, or SD divided by the number of participants in the protocol qualified (PQ) population, then multiplied by 100. Best tumor response of CR, PR, or SD was determined from the sequence of tumor response assessments. Tumor response was assessed using RECIST criteria. CR=disappearance of all target lesions; PR=30% decrease in sum of longest diameter of target lesions; SD=small changes that do not meet above criteria.
Outcome measures
| Measure |
Pem/Cis + Cet
n=109 Participants
Induction Therapy: 500 mg/m² pemetrexed (Pem)on Day 1 of every 21-day cycle, 75 mg/m² cisplatin (Cis) on Day 1 of every 21-day cycle and 400 mg/m² cetuximab (Cet) given intravenously (IV) on Day 1 of Cycle 1 and 250 mg/m² once weekly thereafter. Induction period is 4 to 6 cycles.
Maintenance Therapy: 500 mg/m² pemetrexed (Pem) given intravenously (IV) on Day 1 of each 21 day cycle and 250 mg/m² cetuximab (Cet) given weekly until progressive disease (PD) or treatment discontinuation.
|
|---|---|
|
The Percentage of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) (Disease Control Rate [DCR])
|
59.6 percentage of participants
|
Adverse Events
Pem/Cis + Cet
Serious events: 61 serious events
Other events: 101 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pem/Cis + Cet
n=113 participants at risk
Induction Therapy: 500 mg/m² pemetrexed (Pem)on Day 1 of every 21-day cycle, 75 mg/m² cisplatin (Cis) on Day 1 of every 21-day cycle and 400 mg/m² cetuximab (Cet) given intravenously (IV) on Day 1 of Cycle 1 and 250 mg/m² once weekly thereafter. Induction period is 4 to 6 cycles.
Maintenance Therapy: 500 mg/m² pemetrexed (Pem) given intravenously (IV) on Day 1 of each 21 day cycle and 250 mg/m² cetuximab (Cet) given weekly until progressive disease (PD) or treatment discontinuation.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.3%
6/113 • Number of events 6
Serious Adverse Events are presented regardless of causality.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Blood and lymphatic system disorders
Leukopenia
|
2.7%
3/113 • Number of events 3
Serious Adverse Events are presented regardless of causality.
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.3%
6/113 • Number of events 6
Serious Adverse Events are presented regardless of causality.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.4%
5/113 • Number of events 7
Serious Adverse Events are presented regardless of causality.
|
|
Cardiac disorders
Atrial flutter
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Cardiac disorders
Intracardiac thrombus
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Cardiac disorders
Tachyarrhythmia
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Ear and labyrinth disorders
Vertigo
|
1.8%
2/113 • Number of events 2
Serious Adverse Events are presented regardless of causality.
|
|
Eye disorders
Diplopia
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.8%
2/113 • Number of events 2
Serious Adverse Events are presented regardless of causality.
|
|
Gastrointestinal disorders
Constipation
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.7%
3/113 • Number of events 4
Serious Adverse Events are presented regardless of causality.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Gastrointestinal disorders
Ileus
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Gastrointestinal disorders
Nausea
|
1.8%
2/113 • Number of events 3
Serious Adverse Events are presented regardless of causality.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Gastrointestinal disorders
Stomatitis
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Gastrointestinal disorders
Vomiting
|
4.4%
5/113 • Number of events 5
Serious Adverse Events are presented regardless of causality.
|
|
General disorders
Chest pain
|
1.8%
2/113 • Number of events 2
Serious Adverse Events are presented regardless of causality.
|
|
General disorders
Chills
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
General disorders
Death
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
General disorders
Device occlusion
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
General disorders
Fatigue
|
1.8%
2/113 • Number of events 3
Serious Adverse Events are presented regardless of causality.
|
|
General disorders
General physical health deterioration
|
2.7%
3/113 • Number of events 4
Serious Adverse Events are presented regardless of causality.
|
|
General disorders
Malaise
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
General disorders
Mucosal inflammation
|
0.88%
1/113 • Number of events 3
Serious Adverse Events are presented regardless of causality.
|
|
General disorders
Obstruction
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
General disorders
Oedema peripheral
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
General disorders
Pain
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
General disorders
Pyrexia
|
1.8%
2/113 • Number of events 3
Serious Adverse Events are presented regardless of causality.
|
|
General disorders
Sudden death
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Immune system disorders
Cytokine release syndrome
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Immune system disorders
Drug hypersensitivity
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Immune system disorders
Hypersensitivity
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Infections and infestations
Appendicitis
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Infections and infestations
Biliary sepsis
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Infections and infestations
Catheter site infection
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Infections and infestations
Diverticulitis
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Infections and infestations
Enterococcal sepsis
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Infections and infestations
Erysipelas
|
1.8%
2/113 • Number of events 2
Serious Adverse Events are presented regardless of causality.
|
|
Infections and infestations
Gangrene
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Infections and infestations
Herpes zoster
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Infections and infestations
Infection
|
1.8%
2/113 • Number of events 2
Serious Adverse Events are presented regardless of causality.
|
|
Infections and infestations
Peritonitis
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Infections and infestations
Pneumonia
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Infections and infestations
Sepsis
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Investigations
Alanine aminotransferase increased
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Investigations
Aspartate aminotransferase increased
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Investigations
Haemoglobin decreased
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Investigations
Neutrophil count decreased
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Investigations
White blood cell count decreased
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.8%
2/113 • Number of events 2
Serious Adverse Events are presented regardless of causality.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Nervous system disorders
Convulsion
|
1.8%
2/113 • Number of events 2
Serious Adverse Events are presented regardless of causality.
|
|
Nervous system disorders
Dizziness
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Nervous system disorders
Hemiparesis
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Nervous system disorders
Leukoencephalopathy
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Nervous system disorders
Nerve compression
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Nervous system disorders
Tremor
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Psychiatric disorders
Confusional state
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Renal and urinary disorders
Renal failure
|
1.8%
2/113 • Number of events 2
Serious Adverse Events are presented regardless of causality.
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
2.4%
1/41 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.7%
3/113 • Number of events 4
Serious Adverse Events are presented regardless of causality.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.7%
3/113 • Number of events 3
Serious Adverse Events are presented regardless of causality.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
5.3%
6/113 • Number of events 6
Serious Adverse Events are presented regardless of causality.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.8%
2/113 • Number of events 3
Serious Adverse Events are presented regardless of causality.
|
|
Skin and subcutaneous tissue disorders
Stasis dermatitis
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Vascular disorders
Deep vein thrombosis
|
1.8%
2/113 • Number of events 2
Serious Adverse Events are presented regardless of causality.
|
|
Vascular disorders
Peripheral ischaemia
|
1.8%
2/113 • Number of events 2
Serious Adverse Events are presented regardless of causality.
|
|
Vascular disorders
Thrombosis
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Vascular disorders
Venous thrombosis limb
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
Other adverse events
| Measure |
Pem/Cis + Cet
n=113 participants at risk
Induction Therapy: 500 mg/m² pemetrexed (Pem)on Day 1 of every 21-day cycle, 75 mg/m² cisplatin (Cis) on Day 1 of every 21-day cycle and 400 mg/m² cetuximab (Cet) given intravenously (IV) on Day 1 of Cycle 1 and 250 mg/m² once weekly thereafter. Induction period is 4 to 6 cycles.
Maintenance Therapy: 500 mg/m² pemetrexed (Pem) given intravenously (IV) on Day 1 of each 21 day cycle and 250 mg/m² cetuximab (Cet) given weekly until progressive disease (PD) or treatment discontinuation.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
17.7%
20/113 • Number of events 38
Serious Adverse Events are presented regardless of causality.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Blood and lymphatic system disorders
Haemoglobinaemia
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Blood and lymphatic system disorders
Leukopenia
|
21.2%
24/113 • Number of events 60
Serious Adverse Events are presented regardless of causality.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
1.8%
2/113 • Number of events 2
Serious Adverse Events are presented regardless of causality.
|
|
Blood and lymphatic system disorders
Neutropenia
|
22.1%
25/113 • Number of events 72
Serious Adverse Events are presented regardless of causality.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.2%
7/113 • Number of events 9
Serious Adverse Events are presented regardless of causality.
|
|
Cardiac disorders
Angina pectoris
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Cardiac disorders
Atrial fibrillation
|
1.8%
2/113 • Number of events 2
Serious Adverse Events are presented regardless of causality.
|
|
Cardiac disorders
Cardiac failure
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Cardiac disorders
Cardiac fibrillation
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Cardiac disorders
Palpitations
|
0.88%
1/113 • Number of events 2
Serious Adverse Events are presented regardless of causality.
|
|
Cardiac disorders
Sinus tachycardia
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Cardiac disorders
Tachycardia
|
0.88%
1/113 • Number of events 2
Serious Adverse Events are presented regardless of causality.
|
|
Ear and labyrinth disorders
Deafness
|
3.5%
4/113 • Number of events 5
Serious Adverse Events are presented regardless of causality.
|
|
Ear and labyrinth disorders
Ear haemorrhage
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Ear and labyrinth disorders
External ear pain
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Ear and labyrinth disorders
Tinnitus
|
4.4%
5/113 • Number of events 5
Serious Adverse Events are presented regardless of causality.
|
|
Ear and labyrinth disorders
Vertigo
|
1.8%
2/113 • Number of events 3
Serious Adverse Events are presented regardless of causality.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Eye disorders
Blepharitis
|
2.7%
3/113 • Number of events 3
Serious Adverse Events are presented regardless of causality.
|
|
Eye disorders
Diplopia
|
1.8%
2/113 • Number of events 2
Serious Adverse Events are presented regardless of causality.
|
|
Eye disorders
Dry eye
|
4.4%
5/113 • Number of events 5
Serious Adverse Events are presented regardless of causality.
|
|
Eye disorders
Eye oedema
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Eye disorders
Eyelid disorder
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Eye disorders
Keratitis
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Eye disorders
Lacrimation increased
|
8.8%
10/113 • Number of events 12
Serious Adverse Events are presented regardless of causality.
|
|
Eye disorders
Ocular hyperaemia
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Eye disorders
Ocular surface disease
|
1.8%
2/113 • Number of events 2
Serious Adverse Events are presented regardless of causality.
|
|
Eye disorders
Ulcerative keratitis
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Gastrointestinal disorders
Abdominal distension
|
1.8%
2/113 • Number of events 2
Serious Adverse Events are presented regardless of causality.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.2%
7/113 • Number of events 8
Serious Adverse Events are presented regardless of causality.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.4%
5/113 • Number of events 8
Serious Adverse Events are presented regardless of causality.
|
|
Gastrointestinal disorders
Cheilitis
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Gastrointestinal disorders
Constipation
|
25.7%
29/113 • Number of events 33
Serious Adverse Events are presented regardless of causality.
|
|
Gastrointestinal disorders
Diarrhoea
|
21.2%
24/113 • Number of events 36
Serious Adverse Events are presented regardless of causality.
|
|
Gastrointestinal disorders
Dry mouth
|
4.4%
5/113 • Number of events 5
Serious Adverse Events are presented regardless of causality.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.1%
8/113 • Number of events 8
Serious Adverse Events are presented regardless of causality.
|
|
Gastrointestinal disorders
Dysphagia
|
7.1%
8/113 • Number of events 9
Serious Adverse Events are presented regardless of causality.
|
|
Gastrointestinal disorders
Eructation
|
1.8%
2/113 • Number of events 2
Serious Adverse Events are presented regardless of causality.
|
|
Gastrointestinal disorders
Gastritis
|
5.3%
6/113 • Number of events 9
Serious Adverse Events are presented regardless of causality.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Gastrointestinal disorders
Gastrointestinal ulcer
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Gastrointestinal disorders
Glossitis
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Gastrointestinal disorders
Glossodynia
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.8%
2/113 • Number of events 2
Serious Adverse Events are presented regardless of causality.
|
|
Gastrointestinal disorders
Nausea
|
45.1%
51/113 • Number of events 95
Serious Adverse Events are presented regardless of causality.
|
|
Gastrointestinal disorders
Odynophagia
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Gastrointestinal disorders
Oesophagitis
|
1.8%
2/113 • Number of events 3
Serious Adverse Events are presented regardless of causality.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
1.8%
2/113 • Number of events 2
Serious Adverse Events are presented regardless of causality.
|
|
Gastrointestinal disorders
Stomatitis
|
20.4%
23/113 • Number of events 38
Serious Adverse Events are presented regardless of causality.
|
|
Gastrointestinal disorders
Vomiting
|
30.1%
34/113 • Number of events 58
Serious Adverse Events are presented regardless of causality.
|
|
General disorders
Asthenia
|
13.3%
15/113 • Number of events 20
Serious Adverse Events are presented regardless of causality.
|
|
General disorders
Catheter site pain
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
General disorders
Chest pain
|
7.1%
8/113 • Number of events 8
Serious Adverse Events are presented regardless of causality.
|
|
General disorders
Chills
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
General disorders
Extravasation
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
General disorders
Facial pain
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
General disorders
Fatigue
|
32.7%
37/113 • Number of events 81
Serious Adverse Events are presented regardless of causality.
|
|
General disorders
Feeling cold
|
1.8%
2/113 • Number of events 2
Serious Adverse Events are presented regardless of causality.
|
|
General disorders
Generalised oedema
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
General disorders
Hernia
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
General disorders
Influenza like illness
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
General disorders
Localised oedema
|
1.8%
2/113 • Number of events 2
Serious Adverse Events are presented regardless of causality.
|
|
General disorders
Malaise
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
General disorders
Mucosal dryness
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
General disorders
Mucosal inflammation
|
18.6%
21/113 • Number of events 30
Serious Adverse Events are presented regardless of causality.
|
|
General disorders
Oedema peripheral
|
8.0%
9/113 • Number of events 12
Serious Adverse Events are presented regardless of causality.
|
|
General disorders
Pain
|
1.8%
2/113 • Number of events 2
Serious Adverse Events are presented regardless of causality.
|
|
General disorders
Peripheral swelling
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
General disorders
Pyrexia
|
12.4%
14/113 • Number of events 19
Serious Adverse Events are presented regardless of causality.
|
|
General disorders
Ulcer
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Hepatobiliary disorders
Cholangitis
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Hepatobiliary disorders
Hepatic pain
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.88%
1/113 • Number of events 2
Serious Adverse Events are presented regardless of causality.
|
|
Immune system disorders
Contrast media allergy
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Immune system disorders
Drug hypersensitivity
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Immune system disorders
Hypersensitivity
|
2.7%
3/113 • Number of events 4
Serious Adverse Events are presented regardless of causality.
|
|
Immune system disorders
Seasonal allergy
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Infections and infestations
Bronchitis
|
1.8%
2/113 • Number of events 2
Serious Adverse Events are presented regardless of causality.
|
|
Infections and infestations
Cellulitis
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Infections and infestations
Conjunctivitis
|
14.2%
16/113 • Number of events 25
Serious Adverse Events are presented regardless of causality.
|
|
Infections and infestations
Cystitis
|
1.8%
2/113 • Number of events 2
Serious Adverse Events are presented regardless of causality.
|
|
Infections and infestations
Ear infection
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Infections and infestations
Eye infection
|
1.8%
2/113 • Number of events 2
Serious Adverse Events are presented regardless of causality.
|
|
Infections and infestations
Folliculitis
|
4.4%
5/113 • Number of events 5
Serious Adverse Events are presented regardless of causality.
|
|
Infections and infestations
Gastroenteritis
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Infections and infestations
Herpes simplex
|
1.8%
2/113 • Number of events 2
Serious Adverse Events are presented regardless of causality.
|
|
Infections and infestations
Infection
|
1.8%
2/113 • Number of events 2
Serious Adverse Events are presented regardless of causality.
|
|
Infections and infestations
Influenza
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Infections and infestations
Laryngitis
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Infections and infestations
Localised infection
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Infections and infestations
Nail bed infection
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Infections and infestations
Nail infection
|
4.4%
5/113 • Number of events 6
Serious Adverse Events are presented regardless of causality.
|
|
Infections and infestations
Nasopharyngitis
|
3.5%
4/113 • Number of events 4
Serious Adverse Events are presented regardless of causality.
|
|
Infections and infestations
Oral candidiasis
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Infections and infestations
Oral fungal infection
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Infections and infestations
Oropharyngeal candidiasis
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Infections and infestations
Paronychia
|
1.8%
2/113 • Number of events 2
Serious Adverse Events are presented regardless of causality.
|
|
Infections and infestations
Penile infection
|
1.4%
1/72 • Number of events 3
Serious Adverse Events are presented regardless of causality.
|
|
Infections and infestations
Pharyngitis
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Infections and infestations
Pneumonia
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Infections and infestations
Respiratory tract infection
|
3.5%
4/113 • Number of events 5
Serious Adverse Events are presented regardless of causality.
|
|
Infections and infestations
Rhinitis
|
1.8%
2/113 • Number of events 3
Serious Adverse Events are presented regardless of causality.
|
|
Infections and infestations
Sinusitis
|
1.8%
2/113 • Number of events 3
Serious Adverse Events are presented regardless of causality.
|
|
Infections and infestations
Skin infection
|
1.8%
2/113 • Number of events 2
Serious Adverse Events are presented regardless of causality.
|
|
Infections and infestations
Tooth infection
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Infections and infestations
Upper aerodigestive tract infection
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Infections and infestations
Urinary tract infection
|
3.5%
4/113 • Number of events 5
Serious Adverse Events are presented regardless of causality.
|
|
Infections and infestations
Vaginal infection
|
4.9%
2/41 • Number of events 2
Serious Adverse Events are presented regardless of causality.
|
|
Injury, poisoning and procedural complications
Bone contusion
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Injury, poisoning and procedural complications
Vascular injury
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Injury, poisoning and procedural complications
Wound
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Investigations
Alanine aminotransferase increased
|
5.3%
6/113 • Number of events 13
Serious Adverse Events are presented regardless of causality.
|
|
Investigations
Aspartate aminotransferase increased
|
3.5%
4/113 • Number of events 17
Serious Adverse Events are presented regardless of causality.
|
|
Investigations
Blood calcium
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Investigations
Blood calcium decreased
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Investigations
Blood creatinine decreased
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Investigations
Blood creatinine increased
|
4.4%
5/113 • Number of events 8
Serious Adverse Events are presented regardless of causality.
|
|
Investigations
Blood magnesium decreased
|
3.5%
4/113 • Number of events 6
Serious Adverse Events are presented regardless of causality.
|
|
Investigations
Blood potassium decreased
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Investigations
Blood sodium decreased
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.8%
2/113 • Number of events 6
Serious Adverse Events are presented regardless of causality.
|
|
Investigations
Glomerular filtration rate decreased
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Investigations
Haemoglobin
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Investigations
Haemoglobin decreased
|
9.7%
11/113 • Number of events 20
Serious Adverse Events are presented regardless of causality.
|
|
Investigations
Neutrophil count decreased
|
2.7%
3/113 • Number of events 4
Serious Adverse Events are presented regardless of causality.
|
|
Investigations
Platelet count decreased
|
5.3%
6/113 • Number of events 8
Serious Adverse Events are presented regardless of causality.
|
|
Investigations
Protein c increased
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Investigations
Weight decreased
|
9.7%
11/113 • Number of events 11
Serious Adverse Events are presented regardless of causality.
|
|
Investigations
Weight increased
|
0.88%
1/113 • Number of events 2
Serious Adverse Events are presented regardless of causality.
|
|
Investigations
White blood cell count decreased
|
2.7%
3/113 • Number of events 5
Serious Adverse Events are presented regardless of causality.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
18.6%
21/113 • Number of events 34
Serious Adverse Events are presented regardless of causality.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Metabolism and nutrition disorders
Fluid retention
|
4.4%
5/113 • Number of events 8
Serious Adverse Events are presented regardless of causality.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
3.5%
4/113 • Number of events 7
Serious Adverse Events are presented regardless of causality.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
7.1%
8/113 • Number of events 12
Serious Adverse Events are presented regardless of causality.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
4.4%
5/113 • Number of events 6
Serious Adverse Events are presented regardless of causality.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
7.1%
8/113 • Number of events 8
Serious Adverse Events are presented regardless of causality.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.88%
1/113 • Number of events 3
Serious Adverse Events are presented regardless of causality.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.5%
4/113 • Number of events 5
Serious Adverse Events are presented regardless of causality.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.8%
10/113 • Number of events 19
Serious Adverse Events are presented regardless of causality.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.7%
3/113 • Number of events 3
Serious Adverse Events are presented regardless of causality.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc space narrowing
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
3.5%
4/113 • Number of events 4
Serious Adverse Events are presented regardless of causality.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.7%
3/113 • Number of events 3
Serious Adverse Events are presented regardless of causality.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.2%
7/113 • Number of events 13
Serious Adverse Events are presented regardless of causality.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.8%
2/113 • Number of events 2
Serious Adverse Events are presented regardless of causality.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.7%
3/113 • Number of events 3
Serious Adverse Events are presented regardless of causality.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
2.4%
1/41 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Nervous system disorders
Ageusia
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Nervous system disorders
Ataxia
|
1.8%
2/113 • Number of events 2
Serious Adverse Events are presented regardless of causality.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Nervous system disorders
Dizziness
|
13.3%
15/113 • Number of events 15
Serious Adverse Events are presented regardless of causality.
|
|
Nervous system disorders
Dysarthria
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Nervous system disorders
Dysgeusia
|
7.1%
8/113 • Number of events 9
Serious Adverse Events are presented regardless of causality.
|
|
Nervous system disorders
Headache
|
8.0%
9/113 • Number of events 15
Serious Adverse Events are presented regardless of causality.
|
|
Nervous system disorders
Hypogeusia
|
0.88%
1/113 • Number of events 2
Serious Adverse Events are presented regardless of causality.
|
|
Nervous system disorders
Neuralgia
|
1.8%
2/113 • Number of events 2
Serious Adverse Events are presented regardless of causality.
|
|
Nervous system disorders
Neuropathy peripheral
|
2.7%
3/113 • Number of events 3
Serious Adverse Events are presented regardless of causality.
|
|
Nervous system disorders
Paraesthesia
|
2.7%
3/113 • Number of events 4
Serious Adverse Events are presented regardless of causality.
|
|
Nervous system disorders
Paraparesis
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
1.8%
2/113 • Number of events 2
Serious Adverse Events are presented regardless of causality.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
10.6%
12/113 • Number of events 14
Serious Adverse Events are presented regardless of causality.
|
|
Nervous system disorders
Presyncope
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Nervous system disorders
Somnolence
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Nervous system disorders
Tremor
|
1.8%
2/113 • Number of events 2
Serious Adverse Events are presented regardless of causality.
|
|
Psychiatric disorders
Anxiety
|
1.8%
2/113 • Number of events 2
Serious Adverse Events are presented regardless of causality.
|
|
Psychiatric disorders
Confusional state
|
3.5%
4/113 • Number of events 4
Serious Adverse Events are presented regardless of causality.
|
|
Psychiatric disorders
Depression
|
2.7%
3/113 • Number of events 4
Serious Adverse Events are presented regardless of causality.
|
|
Psychiatric disorders
Fear
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Psychiatric disorders
Insomnia
|
4.4%
5/113 • Number of events 5
Serious Adverse Events are presented regardless of causality.
|
|
Psychiatric disorders
Sleep disorder
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Renal and urinary disorders
Bladder pain
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Renal and urinary disorders
Bladder spasm
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Renal and urinary disorders
Haematuria
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Renal and urinary disorders
Pollakiuria
|
1.8%
2/113 • Number of events 2
Serious Adverse Events are presented regardless of causality.
|
|
Renal and urinary disorders
Renal colic
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Renal and urinary disorders
Renal failure
|
1.8%
2/113 • Number of events 2
Serious Adverse Events are presented regardless of causality.
|
|
Renal and urinary disorders
Urinary retention
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Reproductive system and breast disorders
Balanoposthitis
|
1.4%
1/72 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
1.4%
1/72 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Reproductive system and breast disorders
Menstruation irregular
|
2.4%
1/41 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
2.4%
1/41 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.7%
20/113 • Number of events 24
Serious Adverse Events are presented regardless of causality.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
5.3%
6/113 • Number of events 7
Serious Adverse Events are presented regardless of causality.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
15.9%
18/113 • Number of events 28
Serious Adverse Events are presented regardless of causality.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
1.8%
2/113 • Number of events 2
Serious Adverse Events are presented regardless of causality.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.2%
7/113 • Number of events 7
Serious Adverse Events are presented regardless of causality.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
3.5%
4/113 • Number of events 4
Serious Adverse Events are presented regardless of causality.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
0.88%
1/113 • Number of events 2
Serious Adverse Events are presented regardless of causality.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal ulceration
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.7%
3/113 • Number of events 3
Serious Adverse Events are presented regardless of causality.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
1.8%
2/113 • Number of events 3
Serious Adverse Events are presented regardless of causality.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Skin and subcutaneous tissue disorders
Acne
|
1.8%
2/113 • Number of events 2
Serious Adverse Events are presented regardless of causality.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.1%
8/113 • Number of events 10
Serious Adverse Events are presented regardless of causality.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
1.8%
2/113 • Number of events 2
Serious Adverse Events are presented regardless of causality.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
6.2%
7/113 • Number of events 7
Serious Adverse Events are presented regardless of causality.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
9.7%
11/113 • Number of events 12
Serious Adverse Events are presented regardless of causality.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
2.7%
3/113 • Number of events 4
Serious Adverse Events are presented regardless of causality.
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
1.8%
2/113 • Number of events 2
Serious Adverse Events are presented regardless of causality.
|
|
Skin and subcutaneous tissue disorders
Hirsutism
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.8%
2/113 • Number of events 3
Serious Adverse Events are presented regardless of causality.
|
|
Skin and subcutaneous tissue disorders
Hypertrichosis
|
1.8%
2/113 • Number of events 2
Serious Adverse Events are presented regardless of causality.
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
5.3%
6/113 • Number of events 7
Serious Adverse Events are presented regardless of causality.
|
|
Skin and subcutaneous tissue disorders
Nail toxicity
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
6.2%
7/113 • Number of events 12
Serious Adverse Events are presented regardless of causality.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.7%
3/113 • Number of events 3
Serious Adverse Events are presented regardless of causality.
|
|
Skin and subcutaneous tissue disorders
Rash
|
54.9%
62/113 • Number of events 88
Serious Adverse Events are presented regardless of causality.
|
|
Skin and subcutaneous tissue disorders
Rash follicular
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
1.8%
2/113 • Number of events 2
Serious Adverse Events are presented regardless of causality.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
2.7%
3/113 • Number of events 3
Serious Adverse Events are presented regardless of causality.
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
0.88%
1/113 • Number of events 2
Serious Adverse Events are presented regardless of causality.
|
|
Surgical and medical procedures
Catheter placement
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Surgical and medical procedures
Dental implantation
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Vascular disorders
Deep vein thrombosis
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Vascular disorders
Flushing
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Vascular disorders
Hot flush
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Vascular disorders
Hypertension
|
4.4%
5/113 • Number of events 5
Serious Adverse Events are presented regardless of causality.
|
|
Vascular disorders
Hypotension
|
2.7%
3/113 • Number of events 4
Serious Adverse Events are presented regardless of causality.
|
|
Vascular disorders
Phlebitis
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
|
Vascular disorders
Phlebitis superficial
|
0.88%
1/113 • Number of events 1
Serious Adverse Events are presented regardless of causality.
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60