Trial Outcomes & Findings for Lorlatinib in ALK Inhibitor Treated Unresectable Advanced/Recurrent ALK-Positive Non Small Cell Lung Cancer Patients in India (NCT NCT04541706)
NCT ID: NCT04541706
Last Updated: 2024-12-20
Results Overview
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event did not necessarily need to have a causal relationship with the treatment or usage. A TEAE was defined as an event that emerged during treatment, having been absent pretreatment, or worsened relative to the pretreatment state. If the investigator did not know whether or not the investigational product caused the event, then the event would be handled as "related to investigational product" for reporting purposes, as defined by the sponsor. If the investigator's causality assessment was "unknown but not related to investigational product," this was clearly documented on study records.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
100 participants
Primary outcome timeframe
From Day 1 up to 35 days post last dosing date or the date of initiation of a new anticancer therapy (up to 1.9 years)
Results posted on
2024-12-20
Participant Flow
A total of 111 participants were screened, 10 participants had screen failure and 1 participant died before enrollment, 100 participants were enrolled and received treatment.
Participant milestones
| Measure |
Lorlatinib 100 mg QD
Participants received lorlatinib 100 mg (4 x 25 mg tablets swallowed whole) orally once daily (QD) until disease progression, unacceptable toxicity, or participant refusal/lost to follow-up.
|
|---|---|
|
Overall Study
STARTED
|
100
|
|
Overall Study
COMPLETED
|
55
|
|
Overall Study
NOT COMPLETED
|
45
|
Reasons for withdrawal
| Measure |
Lorlatinib 100 mg QD
Participants received lorlatinib 100 mg (4 x 25 mg tablets swallowed whole) orally once daily (QD) until disease progression, unacceptable toxicity, or participant refusal/lost to follow-up.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Progressive disease
|
33
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Death
|
5
|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Lorlatinib in ALK Inhibitor Treated Unresectable Advanced/Recurrent ALK-Positive Non Small Cell Lung Cancer Patients in India
Baseline characteristics by cohort
| Measure |
Lorlatinib 100 mg QD
n=100 Participants
Participants received lorlatinib 100 mg (4 x 25 mg tablets swallowed whole) orally once daily (QD) until disease progression, unacceptable toxicity, or participant refusal/lost to follow-up.
|
|---|---|
|
Age, Continuous
|
49.0 Years
n=5 Participants
|
|
Age, Customized
<18 years
|
0 Participants
n=5 Participants
|
|
Age, Customized
18-44 years
|
38 Participants
n=5 Participants
|
|
Age, Customized
45-64 years
|
47 Participants
n=5 Participants
|
|
Age, Customized
>=65 years
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
100 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American India or Alaska Native
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to 35 days post last dosing date or the date of initiation of a new anticancer therapy (up to 1.9 years)Population: The safety analysis population included participants who received at least 1 dose of lorlatinib.
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event did not necessarily need to have a causal relationship with the treatment or usage. A TEAE was defined as an event that emerged during treatment, having been absent pretreatment, or worsened relative to the pretreatment state. If the investigator did not know whether or not the investigational product caused the event, then the event would be handled as "related to investigational product" for reporting purposes, as defined by the sponsor. If the investigator's causality assessment was "unknown but not related to investigational product," this was clearly documented on study records.
Outcome measures
| Measure |
Lorlatinib 100 mg QD
n=100 Participants
Participants received lorlatinib 100 mg (4 x 25 mg tablets swallowed whole) orally once daily (QD) until disease progression, unacceptable toxicity, or participant refusal/lost to follow-up.
|
|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
All-causality TEAEs
|
94 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Treatment-related TEAEs
|
89 Participants
|
SECONDARY outcome
Timeframe: Assessed at least 1 year from first dose or until progression of disease, death or received subsequent anti-cancer therapy, whichever came first up to a maximum of 2 years.Population: The analysis population included participants who received at least 1 dose of lorlatinib.
ORR was defined as the percentage of participants with best overall response as confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. ORR was provided along with the corresponding 95% confidence interval (CI) based on Wilson's Score Method. CR was defined as the disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of the target lesions.
Outcome measures
| Measure |
Lorlatinib 100 mg QD
n=100 Participants
Participants received lorlatinib 100 mg (4 x 25 mg tablets swallowed whole) orally once daily (QD) until disease progression, unacceptable toxicity, or participant refusal/lost to follow-up.
|
|---|---|
|
Confirmed Objective Responses Rate (ORR) Based on Investigator Assessment
|
41 Percentage of participants
Interval 31.9 to 50.8
|
SECONDARY outcome
Timeframe: Assessed at least 1 year from first dose or until progression of disease, death or received subsequent anti-cancer therapy, whichever came first up to a maximum of 2 years.Population: The analysis population included participants any intracranial lesions.
IC-ORR was defined as the percentage of participants with intracranial response (ie, best overall intracranial response as confirmed CR or confirmed PR considering only intracranial lesions) relative to participants with central nervous system (CNS) metastases at study entry. IC-ORR was provided along with the corresponding 95% CI based on Wilson's Score Method. CR was defined as the disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of the target lesions.
Outcome measures
| Measure |
Lorlatinib 100 mg QD
n=56 Participants
Participants received lorlatinib 100 mg (4 x 25 mg tablets swallowed whole) orally once daily (QD) until disease progression, unacceptable toxicity, or participant refusal/lost to follow-up.
|
|---|---|
|
Confirmed Intracranial Objective Response Rate (IC-ORR) Based on Investigator Assessment
|
35.7 Percentage of participants
Interval 24.5 to 48.8
|
SECONDARY outcome
Timeframe: Assessed at least 1 year from first dose or until progression of disease, death or received subsequent anti-cancer therapy, whichever came first up to a maximum of 2 years.Population: The analysis population included participants with confirmed objective response.
DoR was defined as the time from the first documentation of objective tumor response (confirmed CR or confirmed PR) to the first documentation of disease progression or death due to any cause, whichever occurred first. For participants whose responses proceed from PR to CR, the onset of PR was taken as the onset of response. CR was defined as the disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of the target lesions.
Outcome measures
| Measure |
Lorlatinib 100 mg QD
n=41 Participants
Participants received lorlatinib 100 mg (4 x 25 mg tablets swallowed whole) orally once daily (QD) until disease progression, unacceptable toxicity, or participant refusal/lost to follow-up.
|
|---|---|
|
Duration of Response (DoR)
|
NA Months
The median DoR was not reached. The survival curve for the DoR did not reach 50% so the median and 95%CI could not be calculated. This was due to having participants who had the highest survival times and had yet to experience the event/disease progression.
|
SECONDARY outcome
Timeframe: Assessed at least 1 year from first dose or until progression of disease, death or received subsequent anti-cancer therapy, whichever came first up to a maximum of 2 years.Population: The analysis population included participants with CNS metastases at baseline and confirmed objective response.
IC-DoR was defined as the time from the first documentation of an intracranial objective response (confirmed CR or confirmed PR) to the first documentation of disease progression or death due to any cause, whichever occurred first in the subgroup of participants with brain metastasis at baseline. CR was defined as the disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of the target lesions.
Outcome measures
| Measure |
Lorlatinib 100 mg QD
n=20 Participants
Participants received lorlatinib 100 mg (4 x 25 mg tablets swallowed whole) orally once daily (QD) until disease progression, unacceptable toxicity, or participant refusal/lost to follow-up.
|
|---|---|
|
Intracranial Duration of Response (IC-DoR)
|
NA Months
Interval 11.1 to
The median DoR was not reached. The survival curve for the DoR did not reach 50% so the median and 95%CI could not be calculated. This was due to having participants who had the highest survival times and had yet to experience the event/disease progression.
|
Adverse Events
Lorlatinib 100 mg QD
Serious events: 22 serious events
Other events: 89 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Lorlatinib 100 mg QD
n=100 participants at risk
Participants received lorlatinib 100 mg (4 x 25 mg tablets swallowed whole) orally once daily (QD) until disease progression, unacceptable toxicity, or participant refusal/lost to follow-up.
|
|---|---|
|
Cardiac disorders
Cardiac arrest
|
1.0%
1/100 • From Day 1 up to 35 days post last dosing date or the date of initiation of a new anticancer therapy (up to 1.9 years)
The same event may appear as both an AE and a serious AE (SAE). An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Cardiac disorders
Cardiac tamponade
|
1.0%
1/100 • From Day 1 up to 35 days post last dosing date or the date of initiation of a new anticancer therapy (up to 1.9 years)
The same event may appear as both an AE and a serious AE (SAE). An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
1.0%
1/100 • From Day 1 up to 35 days post last dosing date or the date of initiation of a new anticancer therapy (up to 1.9 years)
The same event may appear as both an AE and a serious AE (SAE). An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.0%
1/100 • From Day 1 up to 35 days post last dosing date or the date of initiation of a new anticancer therapy (up to 1.9 years)
The same event may appear as both an AE and a serious AE (SAE). An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Sudden death
|
1.0%
1/100 • From Day 1 up to 35 days post last dosing date or the date of initiation of a new anticancer therapy (up to 1.9 years)
The same event may appear as both an AE and a serious AE (SAE). An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
COVID-19
|
4.0%
4/100 • From Day 1 up to 35 days post last dosing date or the date of initiation of a new anticancer therapy (up to 1.9 years)
The same event may appear as both an AE and a serious AE (SAE). An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
COVID-19 pneumonia
|
1.0%
1/100 • From Day 1 up to 35 days post last dosing date or the date of initiation of a new anticancer therapy (up to 1.9 years)
The same event may appear as both an AE and a serious AE (SAE). An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Lower respiratory tract infection
|
1.0%
1/100 • From Day 1 up to 35 days post last dosing date or the date of initiation of a new anticancer therapy (up to 1.9 years)
The same event may appear as both an AE and a serious AE (SAE). An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Pneumonia aspiration
|
1.0%
1/100 • From Day 1 up to 35 days post last dosing date or the date of initiation of a new anticancer therapy (up to 1.9 years)
The same event may appear as both an AE and a serious AE (SAE). An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Suspected COVID-19
|
1.0%
1/100 • From Day 1 up to 35 days post last dosing date or the date of initiation of a new anticancer therapy (up to 1.9 years)
The same event may appear as both an AE and a serious AE (SAE). An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
1.0%
1/100 • From Day 1 up to 35 days post last dosing date or the date of initiation of a new anticancer therapy (up to 1.9 years)
The same event may appear as both an AE and a serious AE (SAE). An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
1.0%
1/100 • From Day 1 up to 35 days post last dosing date or the date of initiation of a new anticancer therapy (up to 1.9 years)
The same event may appear as both an AE and a serious AE (SAE). An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
1.0%
1/100 • From Day 1 up to 35 days post last dosing date or the date of initiation of a new anticancer therapy (up to 1.9 years)
The same event may appear as both an AE and a serious AE (SAE). An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Nervous system disorders
Altered state of consciousness
|
1.0%
1/100 • From Day 1 up to 35 days post last dosing date or the date of initiation of a new anticancer therapy (up to 1.9 years)
The same event may appear as both an AE and a serious AE (SAE). An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Nervous system disorders
Cognitive disorder
|
1.0%
1/100 • From Day 1 up to 35 days post last dosing date or the date of initiation of a new anticancer therapy (up to 1.9 years)
The same event may appear as both an AE and a serious AE (SAE). An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Nervous system disorders
Hypersomnia
|
1.0%
1/100 • From Day 1 up to 35 days post last dosing date or the date of initiation of a new anticancer therapy (up to 1.9 years)
The same event may appear as both an AE and a serious AE (SAE). An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Nervous system disorders
Seizure
|
1.0%
1/100 • From Day 1 up to 35 days post last dosing date or the date of initiation of a new anticancer therapy (up to 1.9 years)
The same event may appear as both an AE and a serious AE (SAE). An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Psychiatric disorders
Acute psychosis
|
1.0%
1/100 • From Day 1 up to 35 days post last dosing date or the date of initiation of a new anticancer therapy (up to 1.9 years)
The same event may appear as both an AE and a serious AE (SAE). An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Psychiatric disorders
Mania
|
1.0%
1/100 • From Day 1 up to 35 days post last dosing date or the date of initiation of a new anticancer therapy (up to 1.9 years)
The same event may appear as both an AE and a serious AE (SAE). An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
2.0%
2/100 • From Day 1 up to 35 days post last dosing date or the date of initiation of a new anticancer therapy (up to 1.9 years)
The same event may appear as both an AE and a serious AE (SAE). An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.0%
3/100 • From Day 1 up to 35 days post last dosing date or the date of initiation of a new anticancer therapy (up to 1.9 years)
The same event may appear as both an AE and a serious AE (SAE). An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea at rest
|
1.0%
1/100 • From Day 1 up to 35 days post last dosing date or the date of initiation of a new anticancer therapy (up to 1.9 years)
The same event may appear as both an AE and a serious AE (SAE). An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
1.0%
1/100 • From Day 1 up to 35 days post last dosing date or the date of initiation of a new anticancer therapy (up to 1.9 years)
The same event may appear as both an AE and a serious AE (SAE). An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
Other adverse events
| Measure |
Lorlatinib 100 mg QD
n=100 participants at risk
Participants received lorlatinib 100 mg (4 x 25 mg tablets swallowed whole) orally once daily (QD) until disease progression, unacceptable toxicity, or participant refusal/lost to follow-up.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
26.0%
26/100 • From Day 1 up to 35 days post last dosing date or the date of initiation of a new anticancer therapy (up to 1.9 years)
The same event may appear as both an AE and a serious AE (SAE). An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Oedema
|
7.0%
7/100 • From Day 1 up to 35 days post last dosing date or the date of initiation of a new anticancer therapy (up to 1.9 years)
The same event may appear as both an AE and a serious AE (SAE). An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Oedema peripheral
|
29.0%
29/100 • From Day 1 up to 35 days post last dosing date or the date of initiation of a new anticancer therapy (up to 1.9 years)
The same event may appear as both an AE and a serious AE (SAE). An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Peripheral swelling
|
6.0%
6/100 • From Day 1 up to 35 days post last dosing date or the date of initiation of a new anticancer therapy (up to 1.9 years)
The same event may appear as both an AE and a serious AE (SAE). An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
COVID-19
|
6.0%
6/100 • From Day 1 up to 35 days post last dosing date or the date of initiation of a new anticancer therapy (up to 1.9 years)
The same event may appear as both an AE and a serious AE (SAE). An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Investigations
Weight increased
|
39.0%
39/100 • From Day 1 up to 35 days post last dosing date or the date of initiation of a new anticancer therapy (up to 1.9 years)
The same event may appear as both an AE and a serious AE (SAE). An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
7.0%
7/100 • From Day 1 up to 35 days post last dosing date or the date of initiation of a new anticancer therapy (up to 1.9 years)
The same event may appear as both an AE and a serious AE (SAE). An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
57.0%
57/100 • From Day 1 up to 35 days post last dosing date or the date of initiation of a new anticancer therapy (up to 1.9 years)
The same event may appear as both an AE and a serious AE (SAE). An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
16.0%
16/100 • From Day 1 up to 35 days post last dosing date or the date of initiation of a new anticancer therapy (up to 1.9 years)
The same event may appear as both an AE and a serious AE (SAE). An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
20.0%
20/100 • From Day 1 up to 35 days post last dosing date or the date of initiation of a new anticancer therapy (up to 1.9 years)
The same event may appear as both an AE and a serious AE (SAE). An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
58.0%
58/100 • From Day 1 up to 35 days post last dosing date or the date of initiation of a new anticancer therapy (up to 1.9 years)
The same event may appear as both an AE and a serious AE (SAE). An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
6.0%
6/100 • From Day 1 up to 35 days post last dosing date or the date of initiation of a new anticancer therapy (up to 1.9 years)
The same event may appear as both an AE and a serious AE (SAE). An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
8.0%
8/100 • From Day 1 up to 35 days post last dosing date or the date of initiation of a new anticancer therapy (up to 1.9 years)
The same event may appear as both an AE and a serious AE (SAE). An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.0%
9/100 • From Day 1 up to 35 days post last dosing date or the date of initiation of a new anticancer therapy (up to 1.9 years)
The same event may appear as both an AE and a serious AE (SAE). An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.0%
8/100 • From Day 1 up to 35 days post last dosing date or the date of initiation of a new anticancer therapy (up to 1.9 years)
The same event may appear as both an AE and a serious AE (SAE). An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.0%
8/100 • From Day 1 up to 35 days post last dosing date or the date of initiation of a new anticancer therapy (up to 1.9 years)
The same event may appear as both an AE and a serious AE (SAE). An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Vascular disorders
Hypertension
|
7.0%
7/100 • From Day 1 up to 35 days post last dosing date or the date of initiation of a new anticancer therapy (up to 1.9 years)
The same event may appear as both an AE and a serious AE (SAE). An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER