Trial Outcomes & Findings for A Study of Pembrolizumab (MK-3475) Plus Carboplatin and Paclitaxel as First-line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (MK-3475-B10/KEYNOTE B10) (NCT NCT04489888)
NCT ID: NCT04489888
Last Updated: 2025-06-19
Results Overview
ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters) per Response Evaluation Criteria in Solid Tumors Update and Clarification 1.1 (RECIST 1.1) which was adjusted for this study to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The percentage of participants who experienced a CR or PR as assessed by blinded independent central review based on RECIST 1.1 was presented.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
101 participants
Primary outcome timeframe
Up to ~25 months
Results posted on
2025-06-19
Participant Flow
101 participants were enrolled in the All Participants as Treated (APaT) population. The APaT population consisted of all allocated participants who received at least one dose of study intervention.
Participant milestones
| Measure |
Pembrolizumab + Carboplatin + Paclitaxel
Participants received pembrolizumab plus carboplatin plus paclitaxel. Pembrolizumab was administered via intravenous (IV) infusion at a dose of 200 mg on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Carboplatin was administered via IV infusion at area under curve (AUC) 5 mg/mL/minute on Day 1 of each 21-day cycle for up to 6 cycles (up to \~4 months). At investigator's choice, paclitaxel was administered via IV infusion at a dose of 100 mg/m\^2 on Day 1 and Day 8 of each 21-day cycle for up to 6 cycles (up to \~4 months) or at a dose of 175 mg/m\^2 on Day 1 of each 21-day cycle for up to 6 cycles (up to \~4 months).
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|---|---|
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Overall Study
STARTED
|
101
|
|
Overall Study
COMPLETED
|
0
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|
Overall Study
NOT COMPLETED
|
101
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Reasons for withdrawal
| Measure |
Pembrolizumab + Carboplatin + Paclitaxel
Participants received pembrolizumab plus carboplatin plus paclitaxel. Pembrolizumab was administered via intravenous (IV) infusion at a dose of 200 mg on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Carboplatin was administered via IV infusion at area under curve (AUC) 5 mg/mL/minute on Day 1 of each 21-day cycle for up to 6 cycles (up to \~4 months). At investigator's choice, paclitaxel was administered via IV infusion at a dose of 100 mg/m\^2 on Day 1 and Day 8 of each 21-day cycle for up to 6 cycles (up to \~4 months) or at a dose of 175 mg/m\^2 on Day 1 of each 21-day cycle for up to 6 cycles (up to \~4 months).
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|---|---|
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Overall Study
Death
|
75
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Overall Study
Sponsor Decision
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26
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Baseline Characteristics
A Study of Pembrolizumab (MK-3475) Plus Carboplatin and Paclitaxel as First-line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (MK-3475-B10/KEYNOTE B10)
Baseline characteristics by cohort
| Measure |
Pembrolizumab + Carboplatin + Paclitaxel
n=101 Participants
Participants received pembrolizumab plus carboplatin plus paclitaxel. Pembrolizumab was administered via intravenous (IV) infusion at a dose of 200 mg on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Carboplatin was administered via IV infusion at area under curve (AUC) 5 mg/mL/minute on Day 1 of each 21-day cycle for up to 6 cycles (up to \~4 months). At investigator's choice, paclitaxel was administered via IV infusion at a dose of 100 mg/m\^2 on Day 1 and Day 8 of each 21-day cycle for up to 6 cycles (up to \~4 months) or at a dose of 175 mg/m\^2 on Day 1 of each 21-day cycle for up to 6 cycles (up to \~4 months).
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|---|---|
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Age, Continuous
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63.8 Years
STANDARD_DEVIATION 9.6 • n=99 Participants
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Sex: Female, Male
Female
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16 Participants
n=99 Participants
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Sex: Female, Male
Male
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85 Participants
n=99 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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43 Participants
n=99 Participants
|
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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58 Participants
n=99 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=99 Participants
|
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
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Race (NIH/OMB)
Black or African American
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6 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
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88 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to ~25 monthsPopulation: APaT population, which included all participants enrolled who received at least 1 dose of study intervention
ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters) per Response Evaluation Criteria in Solid Tumors Update and Clarification 1.1 (RECIST 1.1) which was adjusted for this study to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The percentage of participants who experienced a CR or PR as assessed by blinded independent central review based on RECIST 1.1 was presented.
Outcome measures
| Measure |
Pembrolizumab + Carboplatin + Paclitaxel
n=101 Participants
Participants received pembrolizumab plus carboplatin plus paclitaxel. Pembrolizumab was administered via intravenous (IV) infusion at a dose of 200 mg on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Carboplatin was administered via IV infusion at area under curve (AUC) 5 mg/mL/minute on Day 1 of each 21-day cycle for up to 6 cycles (up to \~4 months). At investigator's choice, paclitaxel was administered via IV infusion at a dose of 100 mg/m\^2 on Day 1 and Day 8 of each 21-day cycle for up to 6 cycles (up to \~4 months) or at a dose of 175 mg/m\^2 on Day 1 of each 21-day cycle for up to 6 cycles (up to \~4 months).
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|---|---|
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Objective Response Rate (ORR)
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48.5 Percentage of Participants
Interval 38.4 to 58.7
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SECONDARY outcome
Timeframe: Up to ~25 monthsPopulation: Participants in APaT population who had either a CR or PR
For participants who demonstrated a confirmed Complete Response (CR: Disappearance of all target lesions) or confirmed Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters) per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurred first. RECIST 1.1 was adjusted for this study to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The DOR as assessed by blinded independent central review based on RECIST 1.1 was presented.
Outcome measures
| Measure |
Pembrolizumab + Carboplatin + Paclitaxel
n=49 Participants
Participants received pembrolizumab plus carboplatin plus paclitaxel. Pembrolizumab was administered via intravenous (IV) infusion at a dose of 200 mg on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Carboplatin was administered via IV infusion at area under curve (AUC) 5 mg/mL/minute on Day 1 of each 21-day cycle for up to 6 cycles (up to \~4 months). At investigator's choice, paclitaxel was administered via IV infusion at a dose of 100 mg/m\^2 on Day 1 and Day 8 of each 21-day cycle for up to 6 cycles (up to \~4 months) or at a dose of 175 mg/m\^2 on Day 1 of each 21-day cycle for up to 6 cycles (up to \~4 months).
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|---|---|
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Duration of Response (DOR)
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5.5 Months
Interval 4.2 to 6.7
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SECONDARY outcome
Timeframe: Up to ~25 monthsPopulation: APaT population, which included all participants enrolled who received at least 1 dose of study intervention
PFS was defined as the time from first dose of study treatment to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. RECIST 1.1 was been adjusted for this study to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ. PFS as assessed by blinded independent central review based on RECIST 1.1 was from product-limit (Kaplan-Meier) method for censored data.
Outcome measures
| Measure |
Pembrolizumab + Carboplatin + Paclitaxel
n=101 Participants
Participants received pembrolizumab plus carboplatin plus paclitaxel. Pembrolizumab was administered via intravenous (IV) infusion at a dose of 200 mg on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Carboplatin was administered via IV infusion at area under curve (AUC) 5 mg/mL/minute on Day 1 of each 21-day cycle for up to 6 cycles (up to \~4 months). At investigator's choice, paclitaxel was administered via IV infusion at a dose of 100 mg/m\^2 on Day 1 and Day 8 of each 21-day cycle for up to 6 cycles (up to \~4 months) or at a dose of 175 mg/m\^2 on Day 1 of each 21-day cycle for up to 6 cycles (up to \~4 months).
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|---|---|
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Progression-free Survival (PFS)
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5.6 Months
Interval 5.1 to 6.7
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SECONDARY outcome
Timeframe: Up to ~25 monthsPopulation: APaT population, which included all participants enrolled who received at least 1 dose of study intervention
OS was defined as the time from first dose of study treatment to death due to any cause. PFS as assessed by blinded independent central review based on RECIST 1.1 was from product-limit (Kaplan-Meier) method for censored data.
Outcome measures
| Measure |
Pembrolizumab + Carboplatin + Paclitaxel
n=101 Participants
Participants received pembrolizumab plus carboplatin plus paclitaxel. Pembrolizumab was administered via intravenous (IV) infusion at a dose of 200 mg on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Carboplatin was administered via IV infusion at area under curve (AUC) 5 mg/mL/minute on Day 1 of each 21-day cycle for up to 6 cycles (up to \~4 months). At investigator's choice, paclitaxel was administered via IV infusion at a dose of 100 mg/m\^2 on Day 1 and Day 8 of each 21-day cycle for up to 6 cycles (up to \~4 months) or at a dose of 175 mg/m\^2 on Day 1 of each 21-day cycle for up to 6 cycles (up to \~4 months).
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|---|---|
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Overall Survival (OS)
|
13.1 Months
Interval 9.6 to 15.2
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SECONDARY outcome
Timeframe: Up to ~39 monthsPopulation: APaT population, which included all participants enrolled who received at least 1 dose of study intervention
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experienced an AE was reported.
Outcome measures
| Measure |
Pembrolizumab + Carboplatin + Paclitaxel
n=101 Participants
Participants received pembrolizumab plus carboplatin plus paclitaxel. Pembrolizumab was administered via intravenous (IV) infusion at a dose of 200 mg on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Carboplatin was administered via IV infusion at area under curve (AUC) 5 mg/mL/minute on Day 1 of each 21-day cycle for up to 6 cycles (up to \~4 months). At investigator's choice, paclitaxel was administered via IV infusion at a dose of 100 mg/m\^2 on Day 1 and Day 8 of each 21-day cycle for up to 6 cycles (up to \~4 months) or at a dose of 175 mg/m\^2 on Day 1 of each 21-day cycle for up to 6 cycles (up to \~4 months).
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|---|---|
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Percentage of Participants Who Experienced an Adverse Event (AE)
|
100.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to ~25 monthsPopulation: APaT population, which included all participants enrolled who received at least 1 dose of study intervention.
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinued study treatment due to an AE was reported.
Outcome measures
| Measure |
Pembrolizumab + Carboplatin + Paclitaxel
n=101 Participants
Participants received pembrolizumab plus carboplatin plus paclitaxel. Pembrolizumab was administered via intravenous (IV) infusion at a dose of 200 mg on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Carboplatin was administered via IV infusion at area under curve (AUC) 5 mg/mL/minute on Day 1 of each 21-day cycle for up to 6 cycles (up to \~4 months). At investigator's choice, paclitaxel was administered via IV infusion at a dose of 100 mg/m\^2 on Day 1 and Day 8 of each 21-day cycle for up to 6 cycles (up to \~4 months) or at a dose of 175 mg/m\^2 on Day 1 of each 21-day cycle for up to 6 cycles (up to \~4 months).
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|---|---|
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Percentage of Participants Who Discontinued Study Treatment Due to an AE
|
36.6 Percentage of Participants
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Adverse Events
Pembrolizumab + Carboplatin + Paclitaxel
Serious events: 52 serious events
Other events: 100 other events
Deaths: 75 deaths
Serious adverse events
| Measure |
Pembrolizumab + Carboplatin + Paclitaxel
n=101 participants at risk
Participants received pembrolizumab plus carboplatin plus paclitaxel. Pembrolizumab was administered via intravenous (IV) infusion at a dose of 200 mg on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Carboplatin was administered via IV infusion at area under curve (AUC) 5 mg/mL/minute on Day 1 of each 21-day cycle for up to 6 cycles (up to \~4 months). At investigator's choice, paclitaxel was administered via IV infusion at a dose of 100 mg/m\^2 on Day 1 and Day 8 of each 21-day cycle for up to 6 cycles (up to \~4 months) or at a dose of 175 mg/m\^2 on Day 1 of each 21-day cycle for up to 6 cycles (up to \~4 months).
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|---|---|
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Blood and lymphatic system disorders
Anaemia
|
3.0%
3/101 • Number of events 3 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.9%
6/101 • Number of events 6 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
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|
Cardiac disorders
Atrial flutter
|
0.99%
1/101 • Number of events 1 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.99%
1/101 • Number of events 1 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
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|
Gastrointestinal disorders
Colitis
|
0.99%
1/101 • Number of events 1 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Dysphagia
|
0.99%
1/101 • Number of events 1 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Faecaloma
|
0.99%
1/101 • Number of events 1 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.99%
1/101 • Number of events 1 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.99%
1/101 • Number of events 1 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.99%
1/101 • Number of events 1 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
0.99%
1/101 • Number of events 1 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Nausea
|
2.0%
2/101 • Number of events 2 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Tongue necrosis
|
0.99%
1/101 • Number of events 1 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
General disorders
Death
|
0.99%
1/101 • Number of events 1 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
General disorders
Fatigue
|
2.0%
2/101 • Number of events 2 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
General disorders
Sudden death
|
0.99%
1/101 • Number of events 1 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.99%
1/101 • Number of events 1 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Immune system disorders
Hypersensitivity
|
0.99%
1/101 • Number of events 1 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Appendicitis
|
0.99%
1/101 • Number of events 1 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
COVID-19
|
2.0%
2/101 • Number of events 2 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
COVID-19 pneumonia
|
2.0%
2/101 • Number of events 2 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Endophthalmitis
|
0.99%
1/101 • Number of events 1 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Fungal infection
|
0.99%
1/101 • Number of events 1 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Gastroenteritis
|
0.99%
1/101 • Number of events 1 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Infected fistula
|
0.99%
1/101 • Number of events 1 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Intestinal sepsis
|
0.99%
1/101 • Number of events 1 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Myelitis
|
0.99%
1/101 • Number of events 1 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Pneumonia
|
11.9%
12/101 • Number of events 13 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Pneumonia aspiration
|
5.9%
6/101 • Number of events 7 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.99%
1/101 • Number of events 1 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Sepsis
|
4.0%
4/101 • Number of events 4 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Septic shock
|
2.0%
2/101 • Number of events 2 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Stoma site infection
|
0.99%
1/101 • Number of events 1 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Urinary tract infection
|
0.99%
1/101 • Number of events 1 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Injury, poisoning and procedural complications
Gastrointestinal stoma complication
|
0.99%
1/101 • Number of events 2 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.99%
1/101 • Number of events 1 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.99%
1/101 • Number of events 1 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.99%
1/101 • Number of events 1 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Investigations
Neutrophil count decreased
|
5.0%
5/101 • Number of events 5 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.0%
3/101 • Number of events 3 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.99%
1/101 • Number of events 1 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.0%
2/101 • Number of events 2 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.99%
1/101 • Number of events 1 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.99%
1/101 • Number of events 5 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.99%
1/101 • Number of events 1 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
3.0%
3/101 • Number of events 3 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Nervous system disorders
Presyncope
|
0.99%
1/101 • Number of events 1 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Nervous system disorders
Seizure
|
2.0%
2/101 • Number of events 2 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Nervous system disorders
Vocal cord paralysis
|
0.99%
1/101 • Number of events 1 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Renal and urinary disorders
Acute kidney injury
|
3.0%
3/101 • Number of events 3 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.99%
1/101 • Number of events 1 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.99%
1/101 • Number of events 1 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.99%
1/101 • Number of events 1 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.99%
1/101 • Number of events 1 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.0%
2/101 • Number of events 2 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.99%
1/101 • Number of events 1 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.99%
1/101 • Number of events 1 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.99%
1/101 • Number of events 1 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.0%
2/101 • Number of events 2 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.0%
3/101 • Number of events 3 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary infarction
|
0.99%
1/101 • Number of events 1 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.99%
1/101 • Number of events 1 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.99%
1/101 • Number of events 1 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.99%
1/101 • Number of events 1 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Vascular disorders
Embolism
|
0.99%
1/101 • Number of events 1 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
Other adverse events
| Measure |
Pembrolizumab + Carboplatin + Paclitaxel
n=101 participants at risk
Participants received pembrolizumab plus carboplatin plus paclitaxel. Pembrolizumab was administered via intravenous (IV) infusion at a dose of 200 mg on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Carboplatin was administered via IV infusion at area under curve (AUC) 5 mg/mL/minute on Day 1 of each 21-day cycle for up to 6 cycles (up to \~4 months). At investigator's choice, paclitaxel was administered via IV infusion at a dose of 100 mg/m\^2 on Day 1 and Day 8 of each 21-day cycle for up to 6 cycles (up to \~4 months) or at a dose of 175 mg/m\^2 on Day 1 of each 21-day cycle for up to 6 cycles (up to \~4 months).
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
46.5%
47/101 • Number of events 64 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Ear and labyrinth disorders
Ear pain
|
5.9%
6/101 • Number of events 6 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Endocrine disorders
Hypothyroidism
|
18.8%
19/101 • Number of events 19 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.9%
11/101 • Number of events 13 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Constipation
|
39.6%
40/101 • Number of events 57 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Diarrhoea
|
31.7%
32/101 • Number of events 64 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Dry mouth
|
12.9%
13/101 • Number of events 13 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.9%
9/101 • Number of events 11 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Dysphagia
|
13.9%
14/101 • Number of events 14 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Nausea
|
35.6%
36/101 • Number of events 49 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Stomatitis
|
8.9%
9/101 • Number of events 11 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Vomiting
|
20.8%
21/101 • Number of events 31 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
General disorders
Asthenia
|
12.9%
13/101 • Number of events 13 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
General disorders
Face oedema
|
5.9%
6/101 • Number of events 6 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
General disorders
Fatigue
|
46.5%
47/101 • Number of events 54 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
General disorders
Mucosal inflammation
|
7.9%
8/101 • Number of events 9 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
General disorders
Oedema peripheral
|
10.9%
11/101 • Number of events 11 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
General disorders
Pyrexia
|
9.9%
10/101 • Number of events 11 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
COVID-19
|
6.9%
7/101 • Number of events 7 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
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Infections and infestations
Candida infection
|
5.9%
6/101 • Number of events 7 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
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Infections and infestations
Oral candidiasis
|
5.9%
6/101 • Number of events 7 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
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Infections and infestations
Pneumonia
|
14.9%
15/101 • Number of events 16 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
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Injury, poisoning and procedural complications
Fall
|
6.9%
7/101 • Number of events 8 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
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Investigations
Alanine aminotransferase increased
|
6.9%
7/101 • Number of events 7 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
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Investigations
Aspartate aminotransferase increased
|
9.9%
10/101 • Number of events 10 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
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Investigations
Blood alkaline phosphatase increased
|
8.9%
9/101 • Number of events 13 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
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Investigations
Blood creatinine increased
|
10.9%
11/101 • Number of events 15 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
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Investigations
Lymphocyte count decreased
|
24.8%
25/101 • Number of events 44 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
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Investigations
Neutrophil count decreased
|
56.4%
57/101 • Number of events 140 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
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Investigations
Platelet count decreased
|
31.7%
32/101 • Number of events 63 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
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Investigations
Weight decreased
|
22.8%
23/101 • Number of events 25 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
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Investigations
White blood cell count decreased
|
33.7%
34/101 • Number of events 87 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
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Metabolism and nutrition disorders
Decreased appetite
|
24.8%
25/101 • Number of events 28 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
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Metabolism and nutrition disorders
Dehydration
|
11.9%
12/101 • Number of events 16 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
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Metabolism and nutrition disorders
Hypercalcaemia
|
7.9%
8/101 • Number of events 10 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
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Metabolism and nutrition disorders
Hyperglycaemia
|
12.9%
13/101 • Number of events 16 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
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Metabolism and nutrition disorders
Hypoalbuminaemia
|
11.9%
12/101 • Number of events 17 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
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Metabolism and nutrition disorders
Hypocalcaemia
|
6.9%
7/101 • Number of events 15 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
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Metabolism and nutrition disorders
Hypokalaemia
|
7.9%
8/101 • Number of events 19 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
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Metabolism and nutrition disorders
Hypomagnesaemia
|
15.8%
16/101 • Number of events 20 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
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Metabolism and nutrition disorders
Hyponatraemia
|
14.9%
15/101 • Number of events 29 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
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Metabolism and nutrition disorders
Hypophosphataemia
|
5.9%
6/101 • Number of events 8 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
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Musculoskeletal and connective tissue disorders
Arthralgia
|
23.8%
24/101 • Number of events 34 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
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Musculoskeletal and connective tissue disorders
Back pain
|
8.9%
9/101 • Number of events 9 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
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Musculoskeletal and connective tissue disorders
Muscular weakness
|
8.9%
9/101 • Number of events 10 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
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Musculoskeletal and connective tissue disorders
Myalgia
|
16.8%
17/101 • Number of events 20 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
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Musculoskeletal and connective tissue disorders
Neck pain
|
6.9%
7/101 • Number of events 8 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
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Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.9%
10/101 • Number of events 13 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
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Nervous system disorders
Dizziness
|
13.9%
14/101 • Number of events 16 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Nervous system disorders
Dysgeusia
|
10.9%
11/101 • Number of events 11 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
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Nervous system disorders
Headache
|
13.9%
14/101 • Number of events 21 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Nervous system disorders
Neuropathy peripheral
|
13.9%
14/101 • Number of events 14 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Nervous system disorders
Paraesthesia
|
10.9%
11/101 • Number of events 12 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
11.9%
12/101 • Number of events 13 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
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|
Psychiatric disorders
Insomnia
|
14.9%
15/101 • Number of events 15 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.8%
16/101 • Number of events 19 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.9%
15/101 • Number of events 18 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.9%
6/101 • Number of events 6 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
34.7%
35/101 • Number of events 35 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.9%
6/101 • Number of events 6 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.9%
13/101 • Number of events 20 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash
|
13.9%
14/101 • Number of events 20 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Vascular disorders
Hypertension
|
12.9%
13/101 • Number of events 29 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Vascular disorders
Hypotension
|
11.9%
12/101 • Number of events 16 • Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
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Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If publication activity was not directed by the Sponsor, the investigator agreed to submit all manuscripts or abstracts to the Sponsor before submission. This allowed the Sponsor to protect proprietary information and to provide comments.
- Publication restrictions are in place
Restriction type: OTHER