Trial Outcomes & Findings for Study of Pembrolizumab (MK-3475) in Participants With Advanced Melanoma (MK-3475-041/KEYNOTE-041) (NCT NCT02180061)
NCT ID: NCT02180061
Last Updated: 2020-03-31
Results Overview
The ORR, using RECIST 1.1, was defined as the percentage of participants in the analysis population who had a confirmed Complete Response (CR; disappearance of all target lesions) or Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions) at any time during the study, based on central radiology review.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
42 participants
Primary outcome timeframe
Up to 24 months
Results posted on
2020-03-31
Participant Flow
These results include data received prior to the safety database cutoff date of 23-Oct-2017.
Participant milestones
| Measure |
Advanced Cutaneous Melanoma
Participants with advanced cutaneous melanoma received pembrolizumab, 2 mg/kg, intravenously (IV) over 30 minutes on Day 1 of each 3-week dosing cycle (Q3W).
|
Advanced Mucosal Melanoma
Participants with advanced mucosal melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
8
|
|
Overall Study
COMPLETED
|
9
|
0
|
|
Overall Study
NOT COMPLETED
|
25
|
8
|
Reasons for withdrawal
| Measure |
Advanced Cutaneous Melanoma
Participants with advanced cutaneous melanoma received pembrolizumab, 2 mg/kg, intravenously (IV) over 30 minutes on Day 1 of each 3-week dosing cycle (Q3W).
|
Advanced Mucosal Melanoma
Participants with advanced mucosal melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
2
|
|
Overall Study
Clinical Progression
|
5
|
1
|
|
Overall Study
Progressive Disease
|
15
|
5
|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Study of Pembrolizumab (MK-3475) in Participants With Advanced Melanoma (MK-3475-041/KEYNOTE-041)
Baseline characteristics by cohort
| Measure |
Advanced Cutaneous Melanoma
n=34 Participants
Participants with advanced cutaneous melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
|
Advanced Mucosal Melanoma
n=8 Participants
Participants with advanced mucosal melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.8 Years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
58.6 Years
STANDARD_DEVIATION 15.5 • n=7 Participants
|
63.6 Years
STANDARD_DEVIATION 13.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
34 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)Population: The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.
Outcome measures
| Measure |
Advanced Cutaneous Melanoma
n=34 Participants
Participants with advanced cutaneous melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
|
Advanced Mucosal Melanoma
n=8 Participants
Participants with advanced mucosal melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
|
|---|---|---|
|
Number of Participants Experiencing Adverse Events (AEs)
|
34 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: Up to last dose of study drug (Up to 24 months)Population: The APaT population consisted of all participants who received at least one dose of study drug.
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.
Outcome measures
| Measure |
Advanced Cutaneous Melanoma
n=34 Participants
Participants with advanced cutaneous melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
|
Advanced Mucosal Melanoma
n=8 Participants
Participants with advanced mucosal melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
|
|---|---|---|
|
Number of Participants Discontinuing Treatment Due to AEs
|
5 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Up to 24 monthsPopulation: The Full Analysis Set (FAS) population consisted of all allocated participants who had measurable lesions at the Baseline scan as assessed by central radiology review and received at least one dose of study drug.
The ORR, using RECIST 1.1, was defined as the percentage of participants in the analysis population who had a confirmed Complete Response (CR; disappearance of all target lesions) or Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions) at any time during the study, based on central radiology review.
Outcome measures
| Measure |
Advanced Cutaneous Melanoma
n=29 Participants
Participants with advanced cutaneous melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
|
Advanced Mucosal Melanoma
n=8 Participants
Participants with advanced mucosal melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
|
|---|---|---|
|
Overall Response Rate (ORR) Per Central Radiology Review Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
|
24.1 Percentage of Participants
Interval 10.3 to 43.5
|
25.0 Percentage of Participants
Interval 3.2 to 65.1
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: The FAS population consisted of all allocated participants who had measurable lesions at the Baseline scan as assessed by Investigator review and received at least one dose of study drug.
The ORR, using RECIST 1.1 criteria, was defined as the percentage of participants in the analysis population who had a confirmed Complete Response (CR; disappearance of all target lesions) or Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions) at any time during the study, based on Investigator assessment.
Outcome measures
| Measure |
Advanced Cutaneous Melanoma
n=34 Participants
Participants with advanced cutaneous melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
|
Advanced Mucosal Melanoma
n=8 Participants
Participants with advanced mucosal melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
|
|---|---|---|
|
ORR Per Investigator Assessment Using RECIST 1.1
|
29.4 Percentage of Participants
Interval 15.1 to 47.5
|
37.5 Percentage of Participants
Interval 8.5 to 75.5
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: The FAS population consisted of all allocated participants who had irRC measurable lesions at the Baseline scan as assessed by central radiology review and received at least one dose of study drug.
The ORR, using irRC, was defined as the percentage of participants in the analysis population who had a confirmed Complete Response (irCR; complete disappearance of all tumor lesions, whether measureable or not, and no new lesions) or a Partial Response (irPR; decrease in sum of the products of the 2 largest perpendicular diameters of 50% or greater) at any time during the study, based on central radiology review.
Outcome measures
| Measure |
Advanced Cutaneous Melanoma
n=23 Participants
Participants with advanced cutaneous melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
|
Advanced Mucosal Melanoma
n=8 Participants
Participants with advanced mucosal melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
|
|---|---|---|
|
ORR Per Central Radiology Review Using Immune-related Response Criteria (irRC)
|
30.4 Percentage of Participants
Interval 13.2 to 52.9
|
25.0 Percentage of Participants
Interval 3.2 to 65.1
|
Adverse Events
Advanced Cutaneous Melanoma
Serious events: 13 serious events
Other events: 34 other events
Deaths: 2 deaths
Advanced Mucosal Melanoma
Serious events: 4 serious events
Other events: 8 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Advanced Cutaneous Melanoma
n=34 participants at risk
Participants with advanced cutaneous melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
|
Advanced Mucosal Melanoma
n=8 participants at risk
Participants with advanced mucosal melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.9%
2/34 • Number of events 2 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/8 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Endocrine disorders
Hypophysitis
|
2.9%
1/34 • Number of events 1 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
12.5%
1/8 • Number of events 1 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Eye disorders
Vitreous haemorrhage
|
2.9%
1/34 • Number of events 1 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/8 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.9%
1/34 • Number of events 1 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/8 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Colitis
|
2.9%
1/34 • Number of events 1 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/8 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.9%
1/34 • Number of events 1 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/8 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
2.9%
1/34 • Number of events 1 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/8 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/34 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
12.5%
1/8 • Number of events 1 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/34 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
12.5%
1/8 • Number of events 2 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Death
|
0.00%
0/34 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
12.5%
1/8 • Number of events 1 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Hepatobiliary disorders
Cholangitis
|
2.9%
1/34 • Number of events 1 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/8 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Cellulitis
|
2.9%
1/34 • Number of events 1 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/8 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Lung infection
|
0.00%
0/34 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
12.5%
1/8 • Number of events 1 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Vestibular neuronitis
|
2.9%
1/34 • Number of events 1 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/8 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
2.9%
1/34 • Number of events 1 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/8 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.9%
1/34 • Number of events 1 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/8 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
2.9%
1/34 • Number of events 1 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/8 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
2.9%
1/34 • Number of events 1 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/8 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Cerebral haemorrhage
|
5.9%
2/34 • Number of events 2 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/8 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Encephalopathy
|
2.9%
1/34 • Number of events 1 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/8 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
2.9%
1/34 • Number of events 1 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/8 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/34 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
12.5%
1/8 • Number of events 1 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.9%
1/34 • Number of events 1 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/8 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
Other adverse events
| Measure |
Advanced Cutaneous Melanoma
n=34 participants at risk
Participants with advanced cutaneous melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
|
Advanced Mucosal Melanoma
n=8 participants at risk
Participants with advanced mucosal melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/34 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
12.5%
1/8 • Number of events 1 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
5.9%
2/34 • Number of events 2 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/8 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Endocrine disorders
Hyperthyroidism
|
2.9%
1/34 • Number of events 1 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
12.5%
1/8 • Number of events 1 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Endocrine disorders
Hypothyroidism
|
17.6%
6/34 • Number of events 6 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/8 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Eye disorders
Diplopia
|
0.00%
0/34 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
12.5%
1/8 • Number of events 1 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Eye disorders
Keratitis
|
0.00%
0/34 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
12.5%
1/8 • Number of events 1 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
11.8%
4/34 • Number of events 5 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/8 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Cheilitis
|
8.8%
3/34 • Number of events 3 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/8 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Constipation
|
23.5%
8/34 • Number of events 8 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
12.5%
1/8 • Number of events 1 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Dental caries
|
5.9%
2/34 • Number of events 2 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/8 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Diarrhoea
|
17.6%
6/34 • Number of events 6 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
12.5%
1/8 • Number of events 1 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Dry mouth
|
5.9%
2/34 • Number of events 2 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/8 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.9%
2/34 • Number of events 2 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/8 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Nausea
|
20.6%
7/34 • Number of events 10 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/8 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Stomatitis
|
8.8%
3/34 • Number of events 4 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/8 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Vomiting
|
11.8%
4/34 • Number of events 4 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/8 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Chest pain
|
5.9%
2/34 • Number of events 2 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/8 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Influenza like illness
|
2.9%
1/34 • Number of events 1 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
12.5%
1/8 • Number of events 1 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Malaise
|
14.7%
5/34 • Number of events 7 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
12.5%
1/8 • Number of events 3 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Pyrexia
|
23.5%
8/34 • Number of events 13 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/8 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Infected dermal cyst
|
0.00%
0/34 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
12.5%
1/8 • Number of events 1 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Influenza
|
8.8%
3/34 • Number of events 3 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/8 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Pharyngitis
|
2.9%
1/34 • Number of events 1 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
25.0%
2/8 • Number of events 3 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
41.2%
14/34 • Number of events 25 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
12.5%
1/8 • Number of events 1 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
5.9%
2/34 • Number of events 2 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/8 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Alanine aminotransferase increased
|
5.9%
2/34 • Number of events 2 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
12.5%
1/8 • Number of events 1 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Aspartate aminotransferase increased
|
8.8%
3/34 • Number of events 3 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
12.5%
1/8 • Number of events 1 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Blood creatinine increased
|
2.9%
1/34 • Number of events 1 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
12.5%
1/8 • Number of events 1 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Eosinophil count increased
|
8.8%
3/34 • Number of events 3 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/8 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Lymphocyte count decreased
|
5.9%
2/34 • Number of events 2 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/8 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Weight decreased
|
14.7%
5/34 • Number of events 5 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/8 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Weight increased
|
2.9%
1/34 • Number of events 1 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
12.5%
1/8 • Number of events 1 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
White blood cell count decreased
|
5.9%
2/34 • Number of events 2 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/8 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
14.7%
5/34 • Number of events 5 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
12.5%
1/8 • Number of events 1 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
5.9%
2/34 • Number of events 2 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/8 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
5.9%
2/34 • Number of events 2 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/8 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.8%
4/34 • Number of events 4 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/8 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
8.8%
3/34 • Number of events 3 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/8 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.9%
2/34 • Number of events 2 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
12.5%
1/8 • Number of events 1 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.9%
2/34 • Number of events 2 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/8 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/34 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
12.5%
1/8 • Number of events 1 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
5.9%
2/34 • Number of events 3 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/8 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Dizziness
|
5.9%
2/34 • Number of events 3 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/8 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Dysgeusia
|
2.9%
1/34 • Number of events 1 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
12.5%
1/8 • Number of events 1 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Psychiatric disorders
Insomnia
|
8.8%
3/34 • Number of events 3 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
12.5%
1/8 • Number of events 1 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Reproductive system and breast disorders
Genital haemorrhage
|
0.00%
0/34 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
12.5%
1/8 • Number of events 1 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Reproductive system and breast disorders
Prostatic obstruction
|
0.00%
0/34 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
12.5%
1/8 • Number of events 1 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Reproductive system and breast disorders
Vulvar erosion
|
0.00%
0/34 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
12.5%
1/8 • Number of events 1 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.8%
3/34 • Number of events 3 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
12.5%
1/8 • Number of events 1 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.9%
2/34 • Number of events 2 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/8 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.9%
2/34 • Number of events 2 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
12.5%
1/8 • Number of events 2 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
5.9%
2/34 • Number of events 2 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/8 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.9%
2/34 • Number of events 2 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/8 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
8.8%
3/34 • Number of events 10 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/8 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/34 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
12.5%
1/8 • Number of events 1 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
17.6%
6/34 • Number of events 6 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/8 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
5.9%
2/34 • Number of events 2 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
12.5%
1/8 • Number of events 1 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
5.9%
2/34 • Number of events 2 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/8 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
8.8%
3/34 • Number of events 3 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/8 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
32.4%
11/34 • Number of events 20 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/8 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
5.9%
2/34 • Number of events 2 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/8 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.9%
2/34 • Number of events 4 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
12.5%
1/8 • Number of events 1 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
17.6%
6/34 • Number of events 6 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
12.5%
1/8 • Number of events 1 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
5.9%
2/34 • Number of events 3 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/8 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Skin depigmentation
|
5.9%
2/34 • Number of events 2 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/8 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
5.9%
2/34 • Number of events 2 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/8 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.00%
0/34 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
12.5%
1/8 • Number of events 1 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
11.8%
4/34 • Number of events 5 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/8 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
5.9%
2/34 • Number of events 2 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
12.5%
1/8 • Number of events 1 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Vascular disorders
Hypertension
|
5.9%
2/34 • Number of events 2 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/8 • All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
- Publication restrictions are in place
Restriction type: OTHER