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| ID | Type | Description | Link |
|---|---|---|---|
| I4T-MC-JVCY | Other Identifier | Eli Lilly and Company | |
| 2014-004824-22 | EudraCT Number |
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The main purpose of this study is to evaluate the efficacy and safety of ramucirumab in combination with erlotinib as compared to placebo in combination with erlotinib in previously untreated participants with stage IV non-small cell lung cancer (NSCLC) harboring an activating epidermal growth factor receptor (EGFR) mutation (Exon 19-Del and Exon 21 L858R). Safety and tolerability of ramucirumab in combination with erlotinib will be assessed in Part A before proceeding to Part B.
The purpose of Part C is to determine the efficacy and safety of ramucirumab in combination with gefitinib in previously untreated East Asian participants with EGFR mutation-positive metastatic NSCLC and of ramucirumab in combination with osimertinib in those participants whose disease progressed on ramucirumab and gefitinib and that have T790M - positive metastatic NSCLC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ramucirumab + Erlotinib | Experimental | Part A: 10 milligrams per kilogram (mg/kg) ramucirumab administered every 2 weeks intravenously (IV) in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met. Part B: 10 mg/kg ramucirumab administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met. |
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| Placebo + Erlotinib | Placebo Comparator | Part B: Placebo administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met. |
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| Ramucirumab + Gefitinib or Osimertinib | Experimental | Part C: 10 mg/kg ramucirumab administered every 2 weeks intravenously (IV) + 250 mg Gefitinib or 80 mg Osimertinib daily orally.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ramucirumab | Drug | Administered IV. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part B: Progression Free Survival (PFS) | PFS is defined as the time from the date of randomization to the date of radiographically documented progressive disease (PD) based on investigator assessment, or the date of death due to any cause, whichever is first assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 or more new lesions is also considered progression. | Randomization to Measured Progressive Disease or Death from Any Cause (Up To 37 Months) |
| Number of Participants With Treatment-Emergent Adverse Events | A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section. | Cycle 1 Day 1 through End of Study (Up To 3 Years) |
| Measure | Description | Time Frame |
|---|---|---|
| Part B: Overall Survival (OS) | OS was defined as the time from the date of randomization to the date of death from any cause. For each participant who was not known to have died as of the data-inclusion cutoff date for a particular analysis,OS was censored for that analysis at the date of last contact prior to the data-inclusion cutoff date (contacts considered in the determination of last contact date include adverse event (AE) date, lesion assessment date, visit date, and last known alive date). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Hematology/Oncology - Santa Monica | Los Angeles | California | 90404 | United States | ||
| St. Charles Health System |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40995949 | Derived | Nishino K, Seto T, Nishio M, Nishio K, Kasahara K, Satouchi M, Yoh K, Hayashi H, Enatsu S, Matsui T, Varughese SC, Visseren-Grul C, Nakagawa K. RELAY: safety and efficacy of ramucirumab plus erlotinib in elderly Japanese patients with metastatic EGFR-mutated NSCLC. Future Oncol. 2025 Oct;21(24):3197-3206. doi: 10.1080/14796694.2025.2560225. Epub 2025 Sep 25. | |
| 40458541 |
| Label | URL |
|---|---|
| A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Participants With EGFR Mutation-Positive Metastatic NSCLC | View source |
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Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
This study consists of 3 parts:
Part C data will be reported after study completion.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A: Ramucirumab + Erlotinib | Part A: 10 milligrams per kilogram (mg/kg) ramucirumab administered every 2 weeks intravenously (IV) in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met. |
| FG001 | Part B: Ramucirumab+ Erlotinib |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: Protocol I4T-MC-JVCY(f) | Apr 23, 2018 |
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| Placebo | Drug | Administered IV. |
|
| Erlotinib | Drug | Administered orally. |
|
| Gefitinib | Drug | Administered orally. |
|
| Osimertinib | Drug | Administered orally. |
|
| Randomization to Date of Death from Any Cause (Up To 37 Months) |
| Part B: Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR]) | ORR was defined as the percentage of randomized participants achieving a best overall response of partial response (PR) or complete response (CR) assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR was defined as the disappearance of all lesions, pathological lymph node reduction in short axis to <10 mm, and normalization of tumor marker levels of non-target lesions. PR was at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 or more new lesions is also considered progression. | Randomization to Progressive Disease (Up To 37 Months) |
| Part B: Percentage of Participants With CR, PR, or Stable Disease (SD) (Disease Control Rate [DCR]) | DCR was defined as the percentage of randomized participants achieving a best overall response of CR,PR, or stable disease(SD) assessed via Response Evaluation Criteria in Solid Tumors(RECIST) version 1.1. CR was defined as the disappearance of all lesions,pathological lymph node reduction in short axis to <10 mm, and normalization of tumor marker levels of non-target lesions.PR was at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters.SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive Disease(PD) was at least a 20% increase in the sum of the diameters of target lesions,taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.The appearance of 1 or more new lesions is also considered progression. | Randomization to Progressive Disease (Up To 37 Months) |
| Part B: Duration of Response (DoR) | DoR was defined as the date of first documented CR or PR (responder) to the date of progressive disease or the date of death due to any cause, whichever was earlier. If a responder was not known to have died or have progressive disease, then the participant was censored at the date of last evaluable tumor assessment.CR was defined as the disappearance of all lesions, pathological lymph node reduction in short axis to <10 mm, and normalization of tumor marker levels of non-target lesions. PR was at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 or more new lesions is also considered progression. | Date of Complete Response (CR) or Partial Response (PR) to Date of Objective Disease Progression or Death Due to Any Cause (Up To 37 Months) |
| Part B: Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab | Part B: Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab | Cycle 2 Day 1: Predose; Cycle 4 Day 1: Predose; Cycle 7 Day 1: Predose; Cycle 14 Day 1 |
| Part B: Number of Participants With Anti-Ramucirumab Antibodies | Part B: Number of Participants With Anti-Ramucirumab Antibodies. | Cycle 1 Predose through Follow-up (Up To 37 Months) |
| Part B: Best Change From Baseline on the Lung Cancer Symptom Scale (LCSS) | The LCSS consisted of 9 items: 6 items focused on lung cancer symptoms [loss of appetite, fatigue, cough, dyspnea (shortness of breath), hemoptysis (blood in sputum), and pain] and 3 global items (symptom distress, interference with activity level, and global quality of life). Participant responses to each item were measured using visual analogue scales (VAS) with 100-millimeter (mm) lines. A higher score for any item represented a higher level of symptoms/problems. The LCSS total score was defined as the mean of all 9 items. Average symptom burden index (ASBI) was calculated as the mean of the six symptom-specific questions from the LCSS. Potential scores range from 0 (for best outcome) to 100 (for worst outcome). | Baseline, End of Study (Up To 37 Months) |
| Part B: Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score | The EQ-5D-5L is a standardized instrument used to measure self-reported health status of the participants. It consists of 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). There are 5 response levels (no problems, slight problems, moderate problems, severe problems, and extreme problems/unable to), ranging from 1 to 5 (good to bad). Dimension responses were converted to an index score using UK weights. The index scores were anchored on full health (1.0) to dead (0) with negative values assigned to health states considered worse than death. | Baseline, Cycle 10 (each cycle is 2 weeks) |
| Part B: Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score | The EQ-5D-5L is a standardized instrument used to measure self-reported health status of the participants. It consists of 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). There are 5 response levels (no problems, slight problems, moderate problems, severe problems, and extreme problems/unable to), ranging from 1 to 5 (good to bad). Dimension responses were converted to an index score using UK weights. The index scores were anchored on full health (1.0) to dead (0) with negative values assigned to health states considered worse than death. | Baseline, Cycle 28 (each cycle is 2 weeks) |
| Part B: Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score | The EQ-5D-5L is a standardized instrument used to measure self-reported health status of the participants. It consists of 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). There are 5 response levels (no problems, slight problems, moderate problems, severe problems, and extreme problems/unable to), ranging from 1 to 5 (good to bad). Dimension responses were converted to an index score using UK weights. The index scores were anchored on full health (1.0) to dead (0) with negative values assigned to health states considered worse than death. | Baseline, Cycle 40 (each cycle is 2 weeks) |
| Denver |
| Colorado |
| 80203 |
| United States |
| The Gastroenterology Group, P.C. | Honolulu | Hawaii | 96813 | United States |
| Cancer Center of Kansas | Wichita | Kansas | 67214 | United States |
| Queens Medical Associates | Fresh Meadows | New York | 11366 | United States |
| Levine Cancer Institute | Charlotte | North Carolina | 28204 | United States |
| AHN Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| Cross Cancer Institute | Edmonton | Alberta | T6G 1Z2 | Canada |
| Hôpital Arnaud de Villeneuve - CHU Montpellier | Montpellier | Hérault | 34090 | France |
| Chu Grenoble Alpes | La Tronche | Isère | 38700 | France |
| Hopital Claude Huriez - CHU de Lille | Lille | Nord | 59037 | France |
| Centre Hospitalier Universitaire de Poitiers | Poitiers | Vienne | 86021 | France |
| Hôpital Européen Georges Pompidou | Paris | 75015 | France |
| Robert-Bosch-Krankenhaus | Gerlingen | Baden-Wurttemberg | 70839 | Germany |
| Thoraxklinik Heidelberg gGmbH | Heidelberg | Baden-Wurttemberg | 69126 | Germany |
| Klinikum Köln-Merheim | Cologne | North Rhine-Westphalia | 51109 | Germany |
| Klinikum Chemnitz GmbH | Chemnitz | Saxony | 09113 | Germany |
| Städtisches Krankenhaus Martha-Maria Halle-Dölau gGmbH | Halle | Saxony-Anhalt | 06120 | Germany |
| LungenClinic Grosshansdorf | Großhansdorf | Schleswig-Holstein | 22927 | Germany |
| Helios Klinikum Emil von Behring Berlin-Zehlendorf | Berlin | 14165 | Germany |
| Sotiria Thoracic Diseases Hospital of Athens | Athens | Attikí | 11527 | Greece |
| Queen Mary Hospital | Hong Kong | Hong Kong |
| Queen Elizabeth Hospital | Yau Ma Tei | 999077 | Hong Kong |
| Instituto Tumori Giovanni Paolo II | Bari | Apulia | 70124 | Italy |
| Cro-Irccs | Aviano | Friuli Venezia Giulia | 33081 | Italy |
| Azienda Sanitaria Ospedaliera S Luigi Gonzaga | Orbassano | Torino | 10043 | Italy |
| IRCCS - AOU di Bologna | Bologna | 40138 | Italy |
| Ospedale San Raffaele | Milan | 20132 | Italy |
| Istituto Oncologico Veneto IRCCS | Padova | 35128 | Italy |
| Aichi Cancer Center Hospital | Nagoya | Aichi-ken | 464-8681 | Japan |
| National Cancer Center Hospital East | Kashiwa | Chiba | 277 8577 | Japan |
| Ehime University Hospital | Tōon | Ehime | 791-0295 | Japan |
| Kurume University Hospital | Kurume | Fukuoka | 830-0011 | Japan |
| National Hospital Organization Asahikawa Medical Center | Asahikawa | Hokkaido | 070-8644 | Japan |
| Hyogo Cancer Center | Akashi | Hyōgo | 673-8558 | Japan |
| Hyogo Prefectual Amagasaki General Medical Center | Amagashiki | Hyōgo | 660-8550 | Japan |
| Himeji Medical Center | Himeji | Hyōgo | 670-8520 | Japan |
| Foundation for Biomedical Research and innovation | Kobe | Hyōgo | 650-0047 | Japan |
| Kobe City Medical Center General Hospital | Kobe | Hyōgo | 650-0047 | Japan |
| Kanazawa University Hospital | Kanazawa | Ishikawa-ken | 920-8641 | Japan |
| Kanagawa Cardiovascular and Respiratory Center | Yokohama | Kanagawa | 236-0051 | Japan |
| Kanagawa Cancer Center | Yokohama | Kanagawa | 241-8515 | Japan |
| Sendai Kousei Hospital | Sendai | Miyagi | 9800873 | Japan |
| Niigata Cancer Center Hospital | Niigata | Niigata | 951-8566 | Japan |
| Osaka Habikino Medical Center | Habikino | Osaka | 583-8588 | Japan |
| Kansai Medical University Hospital | Hirakata | Osaka | 573-1191 | Japan |
| Kishiwada City Hospital | Kishiwada | Osaka | 596-8501 | Japan |
| Kindai University Hospital- Osakasayama Campus | Ōsaka-sayama | Osaka | 589-8511 | Japan |
| National Hospital Organization Kinki-Chuo Chest Medical Center | Sakai | Osaka | 5918555 | Japan |
| Saitama Prefectural Cancer Center | Ina-machi | Saitama | 362-0806 | Japan |
| Shizuoka Cancer Center | Nakatogari | Shizuoka | 411-8777 | Japan |
| Tokyo Met Cancer & Infectious Diseases Center Komagome Hp | Bunkyo-ku | Tokyo | 113-8677 | Japan |
| National Cancer Center Hospital | Chuo-Ku | Tokyo | 104-0045 | Japan |
| Japanese Foundation for Cancer Research | Koto | Tokyo | 135-8550 | Japan |
| National Hospital Organization Yamaguchi Ube Medical Center | Ube | Yamaguchi | 755-0241 | Japan |
| Chiba University Hospital | Chiba | 260-8677 | Japan |
| National Hospital Organization Kyushu Medical Center | Fukuoka | 810-8563 | Japan |
| National Hospital Organization Kyushu Cancer Center | Fukuoka | 811-1395 | Japan |
| Kyushu University Hospital | Fukuoka | 812-8582 | Japan |
| Kyoto University Hospital | Kyoto | 606-8507 | Japan |
| Nagasaki University Hospital | Nagasaki | 852-8501 | Japan |
| Niigata University Medical & Dental Hospital | Niigata | 951-8520 | Japan |
| Okayama University Hospital | Okayama | 700-8558 | Japan |
| Osaka City General Hospital | Osaka | 534-0021 | Japan |
| Osaka Medical Center for Cancer and Cardiovascular Diseases | Osaka | 537-8511 | Japan |
| Osaka City University Hospital | Osaka | 545-8586 | Japan |
| St. Lukes International Hospital | Tokyo | 104-8560 | Japan |
| Juntendo University Hospital | Tokyo | 113-8431 | Japan |
| Nippon Medical School Hospital | Tokyo | 113-8603 | Japan |
| Wakayama MedicaL University Hospital | Wakayama | 641-0012 | Japan |
| Institutul Oncologic | Bucharest | Bucharest | 022328 | Romania |
| S.C. MedisProf SRL | Cluj-Napoca | Cluj | 400058 | Romania |
| Chungbuk National University Hospital | Cheongju-si | Chungcheongbuk-do [Chungbuk] | 28644 | South Korea |
| Seoul National University Bundang Hospital | Seongnam | Kyǒnggi-do | 10408 | South Korea |
| The Catholic University Of Korea St. Vincent's Hospital | Suwon | Kyǒnggi-do | 16247 | South Korea |
| Ajou University Hospital | Suwon | Kyǒnggi-do | 16499 | South Korea |
| Gyeongsang National University Hospital | Jinju | Kyǒngsangnam-do | 52727 | South Korea |
| Asan Medical Center | Seoul | Seoul-teukbyeolsi [Seoul] | 05505 | South Korea |
| Samsung Medical Center | Seoul | Seoul-teukbyeolsi [Seoul] | 06351 | South Korea |
| The Catholic Univ. of Korea Seoul St. Mary's Hospital | Seoul | Seoul-teukbyeolsi [Seoul] | 06591 | South Korea |
| Korea University Guro Hospital | Seoul | Seoul-teukbyeolsi [Seoul] | 08308 | South Korea |
| Ulsan University Hospital | Ulsan | Ulsan-Kwangyǒkshi | 44033 | South Korea |
| Hospital Universitari Vall d'Hebron | Barcelona | Barcelona [Barcelona] | 08035 | Spain |
| Instituto Catalan de Oncologia - Hospital Duran i Reynals | Hospitalet | Barcelona [Barcelona] | 08908 | Spain |
| Hospital Son Llatzer | Palma | Illes Balears [Islas Baleares] | 07198 | Spain |
| Hospital Universitario Quironsalud Madrid | Pozuelo de Alarcón | Madrid | 28223 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | Madrid, Comunidad de | 28041 | Spain |
| Clinica Universitaria De Navarra | Pamplona | Navarre | 31008 | Spain |
| Hospital Universitario Virgen del Rocio | Seville | 41013 | Spain |
| Hospital Universitario Virgen de Valme | Seville | 41014 | Spain |
| Hospital Universitari i Politecnic La Fe | Valencia | 46026 | Spain |
| Chang Gung Memorial Hospital at Kaohsiung | Kaohsiung Niao Sung Dist | Kaohsiung | 83301 | Taiwan |
| E-DA Hospital | Kaohsiung City | 82445 | Taiwan |
| China Medical University Hospital | Taichung | 40447 | Taiwan |
| Taichung Veterans General Hospital | Taichung | 40705 | Taiwan |
| National Cheng-Kung University Hospital | Tainan | 704 | Taiwan |
| National Taiwan University Hospital | Taipei | 10002 | Taiwan |
| MacKay Memorial Hospital | Taipei | 10449 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 11217 | Taiwan |
| Ege Universitesi Hastanesi | Bornova | İzmir | 35100 | Turkey (Türkiye) |
| Baskent University Dr. Turgut Noyan Research and Training Center | Adana | 1250 | Turkey (Türkiye) |
| Trakya University | Edirne | 22030 | Turkey (Türkiye) |
| İnönü Üniversitesi Turgut Özal Tıp Merkezi Eğitim ve Araştırma Hastanesi | Malatya | 44280 | Turkey (Türkiye) |
| Royal Marsden Hospital (Chelsea) | London | Kensington and Chelsea | SW3 6JJ | United Kingdom |
| Charing Cross Hospital | Chelsea | London | W6 8RF | United Kingdom |
| City Hospital, Nottingham University Hospitals | Nottingham | Nottinghamshire | NG5 1PB | United Kingdom |
| Nishio M, Seto T, Reck M, Garon EB, Nishio K, Kasahara K, Nishino K, Satouchi M, Yoh K, Hayashi H, Sakai K, Enatsu S, Frimodt-Moller B, Matsui T, Varughese SC, Carlsen M, Visseren-Grul C, Nakagawa K. Final Survival Outcomes With Ramucirumab Plus Erlotinib Versus Placebo Plus Erlotinib in Patients With Untreated EGFR-Mutated Metastatic NSCLC: RELAY Japanese Subset. JTO Clin Res Rep. 2025 Feb 28;6(6):100819. doi: 10.1016/j.jtocrr.2025.100819. eCollection 2025 Jun. |
| 39622410 | Derived | Nakagawa K, Garon EB, Seto T, Nishio M, Aix SP, Paz-Ares L, Chiu CH, Park K, Novello S, Nadal E, Nishino K, Yoh K, Shih JY, Chik JYK, Moro-Sibilot D, Puri T, Chacko Varughese S, Frimodt-Moller B, Visseren-Grul C, Reck M. RELAY: Final Overall Survival for Erlotinib Plus Ramucirumab or Placebo in Untreated, EGFR-Mutated Metastatic NSCLC. J Thorac Oncol. 2025 Apr;20(4):487-499. doi: 10.1016/j.jtho.2024.11.032. Epub 2024 Nov 30. |
| 37691865 | Derived | Nishio K, Sakai K, Nishio M, Seto T, Visseren-Grul C, Carlsen M, Matsui T, Enatsu S, Nakagawa K. Impact of ramucirumab plus erlotinib on circulating cell-free DNA from patients with untreated metastatic non-small cell lung cancer with EGFR-activating mutations (RELAY phase 3 randomized study). Transl Lung Cancer Res. 2023 Aug 30;12(8):1702-1716. doi: 10.21037/tlcr-22-736. Epub 2023 Aug 10. |
| 37390764 | Derived | Garon EB, Reck M, Nishio K, Heymach JV, Nishio M, Novello S, Paz-Ares L, Popat S, Aix SP, Graham H, Butts BD, Visseren-Grul C, Nakagawa K; RELAY study investigators. Ramucirumab plus erlotinib versus placebo plus erlotinib in previously untreated EGFR-mutated metastatic non-small-cell lung cancer (RELAY): exploratory analysis of next-generation sequencing results. ESMO Open. 2023 Aug;8(4):101580. doi: 10.1016/j.esmoop.2023.101580. Epub 2023 Jun 28. |
| 37329423 | Derived | Chiu CH, Lin MC, Wei YF, Chang GC, Su WC, Hsia TC, Su J, Wang AK, Jen MH, Puri T, Shih JY. Efficacy and Tolerability of Ramucirumab Plus Erlotinib in Taiwanese Patients with Untreated, Epidermal Growth Factor Receptor-Mutated, Stage IV Non-small Cell Lung Cancer in the RELAY Study. Target Oncol. 2023 Jul;18(4):505-515. doi: 10.1007/s11523-023-00975-5. Epub 2023 Jun 17. |
| 35841410 | Derived | Nakagawa K, Garon EB, Gao L, Callies S, Zimmermann A, Walgren R, Visseren-Grul C, Reck M. RELAY, ramucirumab plus erlotinib versus placebo plus erlotinib in untreated EGFR-mutated metastatic non-small cell lung cancer: exposure-response relationship. Cancer Chemother Pharmacol. 2022 Aug;90(2):137-148. doi: 10.1007/s00280-022-04447-x. Epub 2022 Jul 16. |
| 35369607 | Derived | Nishio M, Nishio K, Reck M, Garon EB, Imamura F, Kawaguchi T, Yamaguchi H, Ikeda S, Hirano K, Visseren-Grul C, Ceccarelli M, Wijayawardana SR, Zimmermann A, Matsui T, Enatsu S, Nakagawa K. RELAY+: Exploratory Study of Ramucirumab Plus Gefitinib in Untreated Patients With EGFR-Mutated Metastatic NSCLC. JTO Clin Res Rep. 2022 Feb 26;3(4):100303. doi: 10.1016/j.jtocrr.2022.100303. eCollection 2022 Apr. |
| 34928484 | Derived | Nadal E, Horinouchi H, Shih JY, Nakagawa K, Reck M, Garon EB, Wei YF, Kollmeier J, Frimodt-Moller B, Barrett E, Lipkovich O, Visseren-Grul C, Novello S. RELAY, Ramucirumab Plus Erlotinib Versus Placebo Plus Erlotinib in Patients with Untreated, Epidermal Growth Factor Receptor Mutation-Positive, Metastatic Non-Small-Cell Lung Cancer: Safety Profile and Manageability. Drug Saf. 2022 Jan;45(1):45-64. doi: 10.1007/s40264-021-01127-2. Epub 2021 Dec 20. |
| 34795131 | Derived | Mitani S, Chen Y, Inoue K, Mori J, Gao L, Long A, Wakabayashi S. Clinical Impact of a Shortened Infusion Duration of Ramucirumab in Japanese Patients -A Model-Based Approach. Gan To Kagaku Ryoho. 2021 Nov;48(11):1381-1387. |
| 31591063 | Derived | Nakagawa K, Garon EB, Seto T, Nishio M, Ponce Aix S, Paz-Ares L, Chiu CH, Park K, Novello S, Nadal E, Imamura F, Yoh K, Shih JY, Au KH, Moro-Sibilot D, Enatsu S, Zimmermann A, Frimodt-Moller B, Visseren-Grul C, Reck M; RELAY Study Investigators. Ramucirumab plus erlotinib in patients with untreated, EGFR-mutated, advanced non-small-cell lung cancer (RELAY): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2019 Dec;20(12):1655-1669. doi: 10.1016/S1470-2045(19)30634-5. Epub 2019 Oct 4. |
| 29317191 | Derived | Reck M, Garon EB, Paz-Ares L, Ponce S, Jaime JC, Juan O, Nadal E, Kiura K, Widau RC, He S, Dalal R, Lee P, Nakagawa K. Randomized, Double-Blind Phase Ib/III Study of Erlotinib With Ramucirumab or Placebo in Previously Untreated EGFR-Mutant Metastatic Non-Small-Cell Lung Cancer (RELAY): Phase Ib Results. Clin Lung Cancer. 2018 May;19(3):213-220.e4. doi: 10.1016/j.cllc.2017.11.003. Epub 2017 Nov 21. |
| 27894601 | Derived | Garon EB, Reck M, Paz-Ares L, Ponce S, Jaime JC, Juan O, Nadal E, Lee P, Dalal R, Liu J, He S, Treat J, Nakagawa K. Treatment Rationale and Study Design for the RELAY Study: A Multicenter, Randomized, Double-Blind Study of Erlotinib With Ramucirumab or Placebo in Patients With Epidermal Growth Factor Receptor Mutation-Positive Metastatic Non-Small-Cell Lung Cancer. Clin Lung Cancer. 2017 Jan;18(1):96-99. doi: 10.1016/j.cllc.2016.05.023. Epub 2016 Jun 8. |
Part B: 10 mg/kg ramucirumab administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met. |
| FG002 | Part B: Placebo+ Erlotinib | Part B: Placebo administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met. |
| Received at Least One Dose of Study Drug |
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| COMPLETED |
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| NOT COMPLETED |
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All enrolled participants. Part C data will be reported after study completion.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Part A: Ramucirumab + Erlotinib | Part A: 10 milligrams per kilogram (mg/kg) ramucirumab administered every 2 weeks intravenously (IV) in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met. |
| BG001 | Part B: Ramucirumab+ Erlotinib | Part B: 10 mg/kg ramucirumab administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met. |
| BG002 | Part B: Placebo+ Erlotinib | Part B: Placebo administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Region of Enrollment | Count of Participants | Participants | No |
| |||||||||||||||
| Geographic Region | * Geographic region "Other" includes Canada, France, Germany, Italy, Romania, Spain, Turkey, US, UK. | Count of Participants | Participants | No |
|
| 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 | Part B: Progression Free Survival (PFS) | PFS is defined as the time from the date of randomization to the date of radiographically documented progressive disease (PD) based on investigator assessment, or the date of death due to any cause, whichever is first assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 or more new lesions is also considered progression. | Part B: All randomized participants grouped according to their assigned treatment at randomization. Censored participants were: Part B: Ramucirumab+ Erlotinib= 102 and Part B: Placebo+ Erlotinib= 67. Per protocol, Part A did not evaluate efficacy. | Posted | Median | 95% Confidence Interval | Months | Randomization to Measured Progressive Disease or Death from Any Cause (Up To 37 Months) |
|
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| Primary | Number of Participants With Treatment-Emergent Adverse Events | A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section. | All randomized participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | No | Cycle 1 Day 1 through End of Study (Up To 3 Years) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Part B: Overall Survival (OS) | OS was defined as the time from the date of randomization to the date of death from any cause. For each participant who was not known to have died as of the data-inclusion cutoff date for a particular analysis,OS was censored for that analysis at the date of last contact prior to the data-inclusion cutoff date (contacts considered in the determination of last contact date include adverse event (AE) date, lesion assessment date, visit date, and last known alive date). | Part B: All randomized participants grouped according to their assigned treatment at randomization. Censored participants were: Part B: Ramucirumab+ Erlotinib= 187 and Part B: Placebo+ Erlotinib= 183. Per protocol, Part A did not evaluate efficacy. | Posted | Median | 95% Confidence Interval | months | Randomization to Date of Death from Any Cause (Up To 37 Months) |
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| Secondary | Part B: Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR]) | ORR was defined as the percentage of randomized participants achieving a best overall response of partial response (PR) or complete response (CR) assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR was defined as the disappearance of all lesions, pathological lymph node reduction in short axis to <10 mm, and normalization of tumor marker levels of non-target lesions. PR was at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 or more new lesions is also considered progression. | Part B: All randomized participants grouped according to their assigned treatment at randomization. Per protocol, Part A did not evaluate efficacy. | Posted | Number | 95% Confidence Interval | percentage of participants | Randomization to Progressive Disease (Up To 37 Months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Part B: Percentage of Participants With CR, PR, or Stable Disease (SD) (Disease Control Rate [DCR]) | DCR was defined as the percentage of randomized participants achieving a best overall response of CR,PR, or stable disease(SD) assessed via Response Evaluation Criteria in Solid Tumors(RECIST) version 1.1. CR was defined as the disappearance of all lesions,pathological lymph node reduction in short axis to <10 mm, and normalization of tumor marker levels of non-target lesions.PR was at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters.SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive Disease(PD) was at least a 20% increase in the sum of the diameters of target lesions,taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.The appearance of 1 or more new lesions is also considered progression. | Part B: All randomized participants grouped according to their assigned treatment at randomization. Per protocol, Part A did not evaluate efficacy. | Posted | Number | 95% Confidence Interval | percentage of participants | Randomization to Progressive Disease (Up To 37 Months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Part B: Duration of Response (DoR) | DoR was defined as the date of first documented CR or PR (responder) to the date of progressive disease or the date of death due to any cause, whichever was earlier. If a responder was not known to have died or have progressive disease, then the participant was censored at the date of last evaluable tumor assessment.CR was defined as the disappearance of all lesions, pathological lymph node reduction in short axis to <10 mm, and normalization of tumor marker levels of non-target lesions. PR was at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 or more new lesions is also considered progression. | Part B: All randomized participants grouped according to their assigned treatment at randomization that had a response (CR or PR). Per protocol, Part A did not evaluate efficacy. | Posted | Median | 95% Confidence Interval | months | Date of Complete Response (CR) or Partial Response (PR) to Date of Objective Disease Progression or Death Due to Any Cause (Up To 37 Months) |
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| Secondary | Part B: Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab | Part B: Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab | Part B participants who received at least one dose of Ramucirumab+ Erlotinib who had evaluable PK data. Per protocol, Part A did not evaluate PK. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram per milliliter (µg/mL) | Cycle 2 Day 1: Predose; Cycle 4 Day 1: Predose; Cycle 7 Day 1: Predose; Cycle 14 Day 1 |
|
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| Secondary | Part B: Number of Participants With Anti-Ramucirumab Antibodies | Part B: Number of Participants With Anti-Ramucirumab Antibodies. | All participants who received at least one dose of study drug. Per protocol, Part A did not evaluate Anti-Ramucirumab Antibodies . | Posted | Count of Participants | Participants | No | Cycle 1 Predose through Follow-up (Up To 37 Months) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Part B: Best Change From Baseline on the Lung Cancer Symptom Scale (LCSS) | The LCSS consisted of 9 items: 6 items focused on lung cancer symptoms [loss of appetite, fatigue, cough, dyspnea (shortness of breath), hemoptysis (blood in sputum), and pain] and 3 global items (symptom distress, interference with activity level, and global quality of life). Participant responses to each item were measured using visual analogue scales (VAS) with 100-millimeter (mm) lines. A higher score for any item represented a higher level of symptoms/problems. The LCSS total score was defined as the mean of all 9 items. Average symptom burden index (ASBI) was calculated as the mean of the six symptom-specific questions from the LCSS. Potential scores range from 0 (for best outcome) to 100 (for worst outcome). | Part B: All randomized participants who completed the LCSS at baseline and at least once post-baseline. Per protocol, Part A did not evaluate efficacy. | Posted | Least Squares Mean | Standard Error | millimeter | Baseline, End of Study (Up To 37 Months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Part B: Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score | The EQ-5D-5L is a standardized instrument used to measure self-reported health status of the participants. It consists of 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). There are 5 response levels (no problems, slight problems, moderate problems, severe problems, and extreme problems/unable to), ranging from 1 to 5 (good to bad). Dimension responses were converted to an index score using UK weights. The index scores were anchored on full health (1.0) to dead (0) with negative values assigned to health states considered worse than death. | Part B: All randomized participants who completed the EQ-5D-5L at baseline and at least once post-baseline. Per protocol, Part A did not evaluate efficacy. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Cycle 10 (each cycle is 2 weeks) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Part B: Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score | The EQ-5D-5L is a standardized instrument used to measure self-reported health status of the participants. It consists of 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). There are 5 response levels (no problems, slight problems, moderate problems, severe problems, and extreme problems/unable to), ranging from 1 to 5 (good to bad). Dimension responses were converted to an index score using UK weights. The index scores were anchored on full health (1.0) to dead (0) with negative values assigned to health states considered worse than death. | Part B: All randomized participants who completed the EQ-5D-5L at baseline and at least once post-baseline. Per protocol, Part A did not evaluate efficacy. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Cycle 28 (each cycle is 2 weeks) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Part B: Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score | The EQ-5D-5L is a standardized instrument used to measure self-reported health status of the participants. It consists of 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). There are 5 response levels (no problems, slight problems, moderate problems, severe problems, and extreme problems/unable to), ranging from 1 to 5 (good to bad). Dimension responses were converted to an index score using UK weights. The index scores were anchored on full health (1.0) to dead (0) with negative values assigned to health states considered worse than death. | Part B: All randomized participants who completed the EQ-5D-5L at baseline and at least once post-baseline. Per protocol, Part A did not evaluate efficacy. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Cycle 40 (each cycle is 2 weeks) |
|
Up To 3 Years
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants. Part C data will be reported after study completion. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
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 | Part A: Ramucirumab + Erlotinib | Part A: 10 milligrams per kilogram (mg/kg) ramucirumab administered every 2 weeks intravenously (IV) in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met. | 2 | 14 | 0 | 14 | 14 | 14 |
| EG001 | Part B: Ramucirumab + Erlotinib | Part B: 10 mg/kg ramucirumab administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met. | 37 | 224 | 65 | 221 | 220 | 221 |
| EG002 | Part B: Placebo + Erlotinib | Part B: Placebo administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met. | 42 | 225 | 47 | 225 | 225 | 225 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Wolff-parkinson-white syndrome | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Macular fibrosis | Eye disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Colitis ischaemic | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Small intestinal haemorrhage | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Mucous membrane disorder | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hepatic steatosis | Hepatobiliary disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Liver disorder | Hepatobiliary disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Abdominal infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Appendicitis perforated | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Empyema | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Encephalitis influenzal | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Gastroenteritis bacterial | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Infectious pleural effusion | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Meningitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Rash pustular | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Ulna fracture | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
| |
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
| |
| Mesenteric neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
| |
| Ovarian neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
| |
| Pericarditis malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Adjustment disorder | Psychiatric disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Endometriosis | Reproductive system and breast disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pneumomediastinum | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dermatitis exfoliative generalised | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Eczema asteatotic | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hepatectomy | Surgical and medical procedures | MedDRA 21.1 | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Blepharitis | Eye disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Eyelid oedema | Eye disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Ocular discomfort | Eye disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Anal fissure | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Cheilitis | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Oesophageal pain | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Tooth disorder | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Cyst | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Xerosis | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Allergy to arthropod sting | Immune system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Angular cheilitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Bacteriuria | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Eye infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Parotitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Perichondritis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Pulpitis dental | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Rash pustular | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Tinea cruris | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Electrocardiogram qt prolonged | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
| |
| Pyogenic granuloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Leukocyturia | Renal and urinary disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Genital rash | Reproductive system and breast disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Nasal disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Nasal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Orthopnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hair disorder | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hirsutism | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Intertrigo | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Nail dystrophy | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Nail toxicity | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Xeroderma | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dental care | Surgical and medical procedures | MedDRA 21.1 | Systematic Assessment |
| |
| Dental operation | Surgical and medical procedures | MedDRA 21.1 | Systematic Assessment |
| |
| Inguinal hernia repair | Surgical and medical procedures | MedDRA 21.1 | Systematic Assessment |
| |
| Tooth extraction | Surgical and medical procedures | MedDRA 21.1 | Systematic Assessment |
| |
| Vaginal pessary insertion | Surgical and medical procedures | MedDRA 21.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Varicose ulceration | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
| Jan 14, 2020 |
| Prot_000.pdf |
| Prot | Yes | No | No | Study Protocol: Protocol Addendum I4T-MC-JVCY(9) | Aug 15, 2017 | Jan 14, 2020 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 13, 2018 | Jan 14, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000096662 | Ramucirumab |
| D000069347 | Erlotinib Hydrochloride |
| D000077156 | Gefitinib |
| C000596361 | osimertinib |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Part B |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Hong Kong |
|
| United States |
|
| Japan |
|
| United Kingdom |
|
| Spain |
|
| Canada |
|
| South Korea |
|
| Turkey |
|
| Taiwan |
|
| Italy |
|
| France |
|
| Germany |
|
| Other* |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
Part B: Placebo administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met. |
|
|
|
| OG001 |
| Part B: Placebo+ Erlotinib |
Part B: Placebo administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met. |
|
|
|
| Part B: Placebo+ Erlotinib |
Part B: Placebo administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met. |
|
|
|
|
|
|
|
|
|
|
|
|
|