Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 142515 | Registry Identifier | JAPIC-CTI | |
| MK-3475-028 | Other Identifier | Merck | |
| KEYNOTE-28 | Other Identifier | Merck | |
| 2013-004507-39 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will assess the efficacy and safety of pembrolizumab (MK-3475) administered to participants with incurable advanced biomarker-positive solid tumors that have not responded to current therapy or for which current therapy is not appropriate.
The study hypothesis is that administration of pembrolizumab to participants with some types of solid tumors will result in a clinically meaningful response rate.
Qualified participants who complete up to ~2 years of pembrolizumab treatment but progress after discontinuation may be eligible for a second course of pembrolizumab for up to ~1 additional year, at the Investigator's discretion. Per protocol, response or progression during this second course will not count towards efficacy outcome measures and adverse events during this second course will not count towards safety outcome measures.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pembrolizumab | Experimental | Participants receive pembrolizumab 10 mg/kg, intravenously (IV), once every 2 weeks (Q2W) for up to ~2 years |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pembrolizumab | Biological | IV infusion |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | Overall response rate (ORR) was defined as the percentage of participants who experienced a complete response (CR; disappearance of all target lesions) or a Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions) and was assessed using modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by the investigator. | Up to approximately 86 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced an Adverse Event (AE) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants with at least one AE was assessed. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28291584 | Result | Alley EW, Lopez J, Santoro A, Morosky A, Saraf S, Piperdi B, van Brummelen E. Clinical safety and activity of pembrolizumab in patients with malignant pleural mesothelioma (KEYNOTE-028): preliminary results from a non-randomised, open-label, phase 1b trial. Lancet Oncol. 2017 May;18(5):623-630. doi: 10.1016/S1470-2045(17)30169-9. Epub 2017 Mar 11. | |
| 28453692 |
Not provided
Not provided
Not provided
Not provided
Not provided
Per protocol, response/progression or adverse events during the second pembrolizumab course were not counted towards efficacy outcome measures or safety outcome measures respectively.
Per protocol, analyses of disease type cohort was planned and conducted for efficacy outcome measures only.
Participants with a histologically- or cytologically-confirmed diagnosis of 20 advanced (unresectable and/or metastatic) solid tumors, were recruited into a single arm.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Pembrolizumab 10 mg/kg | Participants received pembrolizumab 10 mg/kg intravenously (IV) over 30 minutes once every 2 weeks (Q2W) for up to ~2 years. Qualified participants who completed the first course of pembrolizumab treatment but progressed after discontinuation were eligible for a second course of pembrolizumab at 10 mg/kg IV Q2W for up to ~1 additional year, at the Investigator's discretion. Per protocol participants were presented by treatment received in the single arm study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The analysis population consisted of all allocated participants who received at least one dose of study drug. Per protocol, Baseline Characteristics were summarized by treatment dose.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pembrolizumab (MK-3475) 10 mg/kg | Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to ~2 years. Qualified participants who completed the first course of pembrolizumab treatment but progressed after discontinuation were eligible for a second course of pembrolizumab at 10 mg/kg IV Q2W for up to ~1 additional year, at the Investigator's discretion. Per protocol participants were presented by treatment received in the single arm study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Response Rate (ORR) | Overall response rate (ORR) was defined as the percentage of participants who experienced a complete response (CR; disappearance of all target lesions) or a Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions) and was assessed using modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by the investigator. | The analysis population consisted of all participants who received at least 1 dose of study treatment, had a baseline scan with measurable disease per modified RECIST 1.1 and had the intended indication. Per protocol, participants were analyzed according to disease type. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to approximately 86 months |
|
Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | First Course Pembrolizumab 10 mg/kg | Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to ~2 years. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 28, 2017 | Apr 19, 2022 | Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| C565324 | Parkinson Disease 4, Autosomal Dominant Lewy Body |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C582435 | pembrolizumab |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Up to approximately 28 months |
| Number of Participants Who Discontinued From Study Treatment Due to an AE | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued treatment due to an AE was assessed. | Up to approximately 25 months |
| Progression Free Survival (PFS) | PFS was defined as the time from the date of allocation to the date of the first documentation of disease progression, as determined by investigator per modified RECIST 1.1 or death due to any cause (whichever occurred first). Disease progression was defined as at least 20 percent (%) increase (including an absolute increase of at least 5 millimeter [mm]) in the sum of diameter of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. PFS was estimated and analyzed using Kaplan-Meier method. | Up to approximately 86 months |
| Overall Survival (OS) | OS was defined as the time from the date of allocation to the date of death due to any cause. Participants who were lost to follow-up and those who were alive at the end of the trial were censored at the date of last assessment. | Up to approximately 86 months |
| Duration of Response (DOR) | For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per modified RECIST 1.1, DOR was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. Per modified RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. DOR assessments were based on investigator with confirmation. The DOR according to modified RECIST 1.1 for all participants who experienced a confirmed CR or PR was reported. Per protocol, participants were analyzed according to disease type. | Up to approximately 86 months |
| Ott PA, Piha-Paul SA, Munster P, Pishvaian MJ, van Brummelen EMJ, Cohen RB, Gomez-Roca C, Ejadi S, Stein M, Chan E, Simonelli M, Morosky A, Saraf S, Emancipator K, Koshiji M, Bennouna J. Safety and antitumor activity of the anti-PD-1 antibody pembrolizumab in patients with recurrent carcinoma of the anal canal. Ann Oncol. 2017 May 1;28(5):1036-1041. doi: 10.1093/annonc/mdx029. |
| 28837405 | Result | Hsu C, Lee SH, Ejadi S, Even C, Cohen RB, Le Tourneau C, Mehnert JM, Algazi A, van Brummelen EMJ, Saraf S, Thanigaimani P, Cheng JD, Hansen AR. Safety and Antitumor Activity of Pembrolizumab in Patients With Programmed Death-Ligand 1-Positive Nasopharyngeal Carcinoma: Results of the KEYNOTE-028 Study. J Clin Oncol. 2017 Dec 20;35(36):4050-4056. doi: 10.1200/JCO.2017.73.3675. Epub 2017 Aug 24. |
| 28813164 | Result | Ott PA, Elez E, Hiret S, Kim DW, Morosky A, Saraf S, Piperdi B, Mehnert JM. Pembrolizumab in Patients With Extensive-Stage Small-Cell Lung Cancer: Results From the Phase Ib KEYNOTE-028 Study. J Clin Oncol. 2017 Dec 1;35(34):3823-3829. doi: 10.1200/JCO.2017.72.5069. Epub 2017 Aug 16. |
| 29116900 | Result | Doi T, Piha-Paul SA, Jalal SI, Saraf S, Lunceford J, Koshiji M, Bennouna J. Safety and Antitumor Activity of the Anti-Programmed Death-1 Antibody Pembrolizumab in Patients With Advanced Esophageal Carcinoma. J Clin Oncol. 2018 Jan 1;36(1):61-67. doi: 10.1200/JCO.2017.74.9846. Epub 2017 Nov 8. |
| 29095678 | Result | Frenel JS, Le Tourneau C, O'Neil B, Ott PA, Piha-Paul SA, Gomez-Roca C, van Brummelen EMJ, Rugo HS, Thomas S, Saraf S, Rangwala R, Varga A. Safety and Efficacy of Pembrolizumab in Advanced, Programmed Death Ligand 1-Positive Cervical Cancer: Results From the Phase Ib KEYNOTE-028 Trial. J Clin Oncol. 2017 Dec 20;35(36):4035-4041. doi: 10.1200/JCO.2017.74.5471. Epub 2017 Nov 2. |
| 29284010 | Result | O'Neil BH, Wallmark JM, Lorente D, Elez E, Raimbourg J, Gomez-Roca C, Ejadi S, Piha-Paul SA, Stein MN, Abdul Razak AR, Dotti K, Santoro A, Cohen RB, Gould M, Saraf S, Stein K, Han SW. Safety and antitumor activity of the anti-PD-1 antibody pembrolizumab in patients with advanced colorectal carcinoma. PLoS One. 2017 Dec 28;12(12):e0189848. doi: 10.1371/journal.pone.0189848. eCollection 2017. |
| 29462123 | Result | Cohen RB, Delord JP, Doi T, Piha-Paul SA, Liu SV, Gilbert J, Algazi AP, Damian S, Hong RL, Le Tourneau C, Day D, Varga A, Elez E, Wallmark J, Saraf S, Thanigaimani P, Cheng J, Keam B. Pembrolizumab for the Treatment of Advanced Salivary Gland Carcinoma: Findings of the Phase 1b KEYNOTE-028 Study. Am J Clin Oncol. 2018 Nov;41(11):1083-1088. doi: 10.1097/COC.0000000000000429. |
| 29559561 | Result | Rugo HS, Delord JP, Im SA, Ott PA, Piha-Paul SA, Bedard PL, Sachdev J, Le Tourneau C, van Brummelen EMJ, Varga A, Salgado R, Loi S, Saraf S, Pietrangelo D, Karantza V, Tan AR. Safety and Antitumor Activity of Pembrolizumab in Patients with Estrogen Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer. Clin Cancer Res. 2018 Jun 15;24(12):2804-2811. doi: 10.1158/1078-0432.CCR-17-3452. Epub 2018 Mar 20. |
| 28489510 | Result | Ott PA, Bang YJ, Berton-Rigaud D, Elez E, Pishvaian MJ, Rugo HS, Puzanov I, Mehnert JM, Aung KL, Lopez J, Carrigan M, Saraf S, Chen M, Soria JC. Safety and Antitumor Activity of Pembrolizumab in Advanced Programmed Death Ligand 1-Positive Endometrial Cancer: Results From the KEYNOTE-028 Study. J Clin Oncol. 2017 Aug 1;35(22):2535-2541. doi: 10.1200/JCO.2017.72.5952. Epub 2017 May 10. |
| 30522700 | Result | Varga A, Piha-Paul S, Ott PA, Mehnert JM, Berton-Rigaud D, Morosky A, Yang P, Ruman J, Matei D. Pembrolizumab in patients with programmed death ligand 1-positive advanced ovarian cancer: Analysis of KEYNOTE-028. Gynecol Oncol. 2019 Feb;152(2):243-250. doi: 10.1016/j.ygyno.2018.11.017. Epub 2018 Dec 3. |
| 35101941 | Derived | Cristescu R, Aurora-Garg D, Albright A, Xu L, Liu XQ, Loboda A, Lang L, Jin F, Rubin EH, Snyder A, Lunceford J. Tumor mutational burden predicts the efficacy of pembrolizumab monotherapy: a pan-tumor retrospective analysis of participants with advanced solid tumors. J Immunother Cancer. 2022 Jan;10(1):e003091. doi: 10.1136/jitc-2021-003091. |
| 33496357 | Derived | Reardon DA, Kim TM, Frenel JS, Simonelli M, Lopez J, Subramaniam DS, Siu LL, Wang H, Krishnan S, Stein K, Massard C. Treatment with pembrolizumab in programmed death ligand 1-positive recurrent glioblastoma: Results from the multicohort phase 1 KEYNOTE-028 trial. Cancer. 2021 May 15;127(10):1620-1629. doi: 10.1002/cncr.33378. Epub 2021 Jan 26. |
| 32359091 | Derived | Piha-Paul SA, Oh DY, Ueno M, Malka D, Chung HC, Nagrial A, Kelley RK, Ros W, Italiano A, Nakagawa K, Rugo HS, de Braud F, Varga AI, Hansen A, Wang H, Krishnan S, Norwood KG, Doi T. Efficacy and safety of pembrolizumab for the treatment of advanced biliary cancer: Results from the KEYNOTE-158 and KEYNOTE-028 studies. Int J Cancer. 2020 Oct 15;147(8):2190-2198. doi: 10.1002/ijc.33013. Epub 2020 May 2. |
| 32320048 | Derived | Mehnert JM, Bergsland E, O'Neil BH, Santoro A, Schellens JHM, Cohen RB, Doi T, Ott PA, Pishvaian MJ, Puzanov I, Aung KL, Hsu C, Le Tourneau C, Hollebecque A, Elez E, Tamura K, Gould M, Yang P, Stein K, Piha-Paul SA. Pembrolizumab for the treatment of programmed death-ligand 1-positive advanced carcinoid or pancreatic neuroendocrine tumors: Results from the KEYNOTE-028 study. Cancer. 2020 Jul 1;126(13):3021-3030. doi: 10.1002/cncr.32883. Epub 2020 Apr 22. |
| 30832606 | Derived | Mehnert JM, Varga A, Brose MS, Aggarwal RR, Lin CC, Prawira A, de Braud F, Tamura K, Doi T, Piha-Paul SA, Gilbert J, Saraf S, Thanigaimani P, Cheng JD, Keam B. Safety and antitumor activity of the anti-PD-1 antibody pembrolizumab in patients with advanced, PD-L1-positive papillary or follicular thyroid cancer. BMC Cancer. 2019 Mar 4;19(1):196. doi: 10.1186/s12885-019-5380-3. |
| 30557521 | Derived | Ott PA, Bang YJ, Piha-Paul SA, Razak ARA, Bennouna J, Soria JC, Rugo HS, Cohen RB, O'Neil BH, Mehnert JM, Lopez J, Doi T, van Brummelen EMJ, Cristescu R, Yang P, Emancipator K, Stein K, Ayers M, Joe AK, Lunceford JK. T-Cell-Inflamed Gene-Expression Profile, Programmed Death Ligand 1 Expression, and Tumor Mutational Burden Predict Efficacy in Patients Treated With Pembrolizumab Across 20 Cancers: KEYNOTE-028. J Clin Oncol. 2019 Feb 1;37(4):318-327. doi: 10.1200/JCO.2018.78.2276. Epub 2018 Dec 13. |
| 29992241 | Derived | Hansen AR, Massard C, Ott PA, Haas NB, Lopez JS, Ejadi S, Wallmark JM, Keam B, Delord JP, Aggarwal R, Gould M, Yang P, Keefe SM, Piha-Paul SA. Pembrolizumab for advanced prostate adenocarcinoma: findings of the KEYNOTE-028 study. Ann Oncol. 2018 Aug 1;29(8):1807-1813. doi: 10.1093/annonc/mdy232. |
| Lost to Follow-up |
|
| Death |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Cohort A2: Anal Canal Squamous Cell Carcinoma | Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to ~2 years. This cohort represents all participants who enrolled with anal canal squamous cell carcinoma. |
| OG002 | Cohort A3: Pancreas Adenocarcinoma | Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to ~2 years. This cohort represents all participants who enrolled with pancreas adenocarcinoma. |
| OG003 | Cohort A4: Esophageal Squamous Cell Carcinoma or Adenocarcinoma | Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to ~2 years. This cohort represents all participants who enrolled with esophageal squamous cell carcinoma or adenocarcinoma (including gastroesophageal (GE) junction). |
| OG004 | Cohort A5: Biliary Tract Adenocarcinoma | Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to ~2 years. This cohort represents all participants who enrolled with biliary tract adenocarcinoma (gallbladder and biliary tree, but excluding ampulla of vater cancers). |
| OG005 | Cohort A6: Carcinoid Tumors | Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to ~2 years. This cohort represents all participants who enrolled with carcinoid tumors. |
| OG006 | Cohort A7: Neuroendocrine Carcinomas | Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to ~2 years. This cohort represents all participants who enrolled with neuroendocrine carcinomas (well or moderately differentiated pancreatic neuroendocrine tumor). |
| OG007 | Cohort B1: ER Positive HER2 Negative Breast Cancer | Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to ~2 years. This cohort represents all participants who enrolled with estrogen receptor (ER) positive human epidermal growth factor receptor (HER2) negative breast cancer. |
| OG008 | Cohort B2: Ovarian Epithelial, Fallopian Tube or Primary Peritoneal Carcinoma | Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to ~2 years. This cohort represents all participants who enrolled with ovarian epithelial, fallopian tube or primary peritoneal carcinoma. |
| OG009 | Cohort B3: Endometrial Carcinoma | Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to ~2 years. This cohort represents all participants who enrolled with endometrial carcinoma. |
| OG010 | Cohort B4: Cervical Squamous Cell Cancer | Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to ~2 years. This cohort represents all participants who enrolled with cervical squamous cell cancer. |
| OG011 | Cohort B5: Vulvar Squamous Cell Carcinoma | Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to ~2 years. This cohort represents all participants who enrolled with vulvar squamous cell carcinoma. |
| OG012 | Cohort C1: Small Cell Lung Cancer | Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to ~2 years. This cohort represents all participants who enrolled with small cell lung cancer. |
| OG013 | Cohort C2: Mesothelioma | Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to ~2 years. This cohort represents all participants who enrolled with mesothelioma (malignant pleural mesothelioma). |
| OG014 | Cohort D1: Thyroid Cancer | Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to ~2 years. This cohort represents all participants who enrolled with thyroid cancer (papillary or follicular subtype). |
| OG015 | Cohort D2: Salivary Gland Carcinoma | Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to ~2 years. This cohort represents all participants who enrolled with salivary gland carcinoma. |
| OG016 | Cohort D3: Nasopharyngeal Carcinoma | Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to ~2 years. This cohort represents all participants who enrolled with nasopharyngeal carcinoma. |
| OG017 | Cohort E1: Glioblastoma Multiforme | Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to ~2 years. This cohort represents all participants who enrolled with glioblastoma multiforme. |
| OG018 | Cohort E2: Leiomyosarcoma | Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to ~2 years. This cohort represents all participants who enrolled with leiomyosarcoma. |
| OG019 | Cohort E3: Prostate Adenocarcinoma | Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to ~2 years. This cohort represents all participants who enrolled with prostate adenocarcinoma. |
|
|
| Secondary | Number of Participants Who Experienced an Adverse Event (AE) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants with at least one AE was assessed. | The analysis population consisted of all allocated participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | Up to approximately 28 months |
|
|
|
| Secondary | Number of Participants Who Discontinued From Study Treatment Due to an AE | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued treatment due to an AE was assessed. | The analysis population consisted of all allocated participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | Up to approximately 25 months |
|
|
|
| Secondary | Progression Free Survival (PFS) | PFS was defined as the time from the date of allocation to the date of the first documentation of disease progression, as determined by investigator per modified RECIST 1.1 or death due to any cause (whichever occurred first). Disease progression was defined as at least 20 percent (%) increase (including an absolute increase of at least 5 millimeter [mm]) in the sum of diameter of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. PFS was estimated and analyzed using Kaplan-Meier method. | The analysis population consisted of all participants who received at least 1 dose of study treatment, had a baseline scan with measurable disease per modified RECIST 1.1 and had the intended indication. Per protocol, participants were analyzed according to disease type. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 86 months |
|
|
|
| Secondary | Overall Survival (OS) | OS was defined as the time from the date of allocation to the date of death due to any cause. Participants who were lost to follow-up and those who were alive at the end of the trial were censored at the date of last assessment. | The analysis population consisted of all participants who received at least 1 dose of study treatment, had a baseline scan with measurable disease per modified RECIST 1.1 and had the intended indication. Per protocol, participants were analyzed according to disease type. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 86 months |
|
|
|
| Secondary | Duration of Response (DOR) | For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per modified RECIST 1.1, DOR was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. Per modified RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. DOR assessments were based on investigator with confirmation. The DOR according to modified RECIST 1.1 for all participants who experienced a confirmed CR or PR was reported. Per protocol, participants were analyzed according to disease type. | The analysis population consisted of all participants who received at least 1 dose of study treatment, had a baseline scan with measurable disease per modified RECIST 1.1, had the intended indication, and experienced a response. Per protocol-specified definition, DOR could not be analyzed in arms which did not have a confirmed response of CR or PR. | Posted | Median | Full Range | Months | Up to approximately 86 months |
|
|
|
| 426 |
| 477 |
| 160 |
| 475 |
| 429 |
| 475 |
| EG001 | Second Course Pembrolizumab 10 mg/kg | Qualified participants who completed the first course of pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to ~2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 10 mg/kg IV Q2W for up to ~1 year. | 6 | 11 | 3 | 11 | 10 | 11 |
| Autoimmune haemolytic anaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Acute coronary syndrome | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Atrial tachycardia | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Atrioventricular block complete | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pulseless electrical activity | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Ear haemorrhage | Ear and labyrinth disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypercalcaemia of malignancy | Endocrine disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 24.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Enteritis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Gastrointestinal ulcer | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Large intestinal haemorrhage | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Malignant gastrointestinal obstruction | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Subileus | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Complication associated with device | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Death | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Acute hepatic failure | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Autoimmune hepatitis | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Biliary colic | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Biliary obstruction | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Cholestasis | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hepatic cytolysis | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hepatitis | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Cytokine release syndrome | Immune system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Abdominal sepsis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Biliary sepsis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Clostridium difficile colitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Device related bacteraemia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Device related sepsis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Escherichia sepsis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Helicobacter infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Infectious mononucleosis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Infectious pleural effusion | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Liver abscess | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Lower respiratory tract infection bacterial | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Meningitis bacterial | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Oropharyngeal candidiasis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Osteomyelitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Pelvic abscess | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Peritonitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Pulmonary sepsis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Salmonellosis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Streptococcal sepsis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Subcutaneous abscess | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Gastroenteritis radiation | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Food intolerance | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
|
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
|
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
|
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
|
| Tumour associated fever | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
|
| Tumour compression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
|
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
|
| Altered state of consciousness | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Guillain-Barre syndrome | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hydrocephalus | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Ischaemic stroke | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Myelitis transverse | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Device occlusion | Product Issues | MedDRA 24.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
|
| Mental status changes | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Ureteric dilatation | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Intermenstrual bleeding | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
|
| Vulvovaginal pain | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Noninfective bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Tracheal stenosis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Acute febrile neutrophilic dermatosis | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pemphigoid | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Lymphoedema | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Lymphorrhoea | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 24.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypoacusis | Ear and labyrinth disorders | MedDRA 24.0 | Systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Vulvovaginal dryness | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Gingivitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Mucosal infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Intertrigo | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Jugular vein thrombosis | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 24.0 | Systematic Assessment |
|
| Uveitis | Eye disorders | MedDRA 24.0 | Systematic Assessment |
|
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.