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CIOMS FORM SUSPECT ADVERSE REACTION REPORT I. REACTION INFORMATICN 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 3a. WEIGHT 4-6 REACTION ONSET (first. last) |ta|y Day Month Year 65 Unk Day Month Year PRIVACY PRIVACl Y Years |Female 18 | NOV [2021 7 + 13 DESCRIBE REACTION(S) (including relevant tests/lab data) Event Verbatim [PREFERRED TERM] {Related symptoms if any separated by commas) Traumatic fracture of the head of the right humerus [Humerus fracture] Case Description: Case number# NVSC2022IT011983, is an initial report received from an investigator on 19 Jan 2022 from a clinical study CPDR001X2X01B. This report refers to a 65 year old female subject (center ID: 8001; subject ID: 8001005) enrolled in an open-label, multi-center rollover protocol for continued characterization of safety and tolerability for subjects who have participated in a Novartis-sponsored spartalizumab study as single agent or in combination with other study treatments. (CPDR001X2X01B: <<CLXH254X2101>>). (Continued on Additional Information Page} X O CHECKALL APPROPRIATE TC ADVERSE REACTION PATIENT DIED INVOLVED OR PROLONGED INPATIENT HOSPITALISATION INVOLVED PERSISTENT OR SIGNIFICANT DISABILITY OR INCAPACITY LIFE THREATENING II. SUSPECT DRUG(S) INFORMATION 14. SUSPECT DRUG(S) (include generic name) #1 ) SPARTALIZUMAB (SPARTALIZUMAB) Powder for solution for infusion #2 ) LXH254 LXH254+TAB (LXH254) Tablet 15. DAILY DOSE(S) #1 ) 400 mg, Q4W (every 4 weeks) #2 ) 200 mg, BID (2 times per day) 16. ROUTE(S) OF ADMINISTRATION #1 ) Intravenous use #2 ) Oral use 20. DID REAGTION ABATE AFTER STOPPING DRUG? Oves [no [na 17. INDICATION(S) FOR USE #1 ) Non-small cell lung cancer (Non-small cell lung cancer) #2 ) Non-small cell lung cancer (Non-small cell lung cancer) 18. THERAPY DATES(from/to) #1) 15-0OCT-2021 / Unknown #2 ) 15-OCT-2021 / Unknown 19. THERAPY DURATION #1 ) Unknown #2 ) Unknown 21. DID REACTION REAPPEAR AFTER REINTRODUCTION? Oves Jno [Jna [Il. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction) #1 ) LEVOTHYROXINE (LEVOTHYROXINE) 100 mg; 23-JUN-2020 / Unknown #2 ) CETIRIZINE (CETIRIZINE) 10 mg; 08-JAN-2021 / Unknown #3 ) PARACETAMOL (PARACETAMOL) 500 mg; 12-NOV-2019 / Unknown #4 ) KETOPROFEN LYSINE (KETOPROFEN LYSINE) 8 mg; 21-FEB-2021 / 01-NOV-2022 #5 ) MOVICOL (MACROGOL 3350, POTASSIUM CHLORIDE, SODIUM BIC #6 ) SYMBICORT (BUDESONIDE, FORMOTEROL FUMARATE) ; 23-JUL-2021 / Unknown (Continued on Additional Information Page) 23. OTHER RELEVANT HISTORY. {e. g. diagnostics, allergies, pregnancy with last month of period, etc. ) From/To Dates Type of History / Notes Description 1980 to Ongoing Current Condition Basedow's disease (Basedow's disease) 2000 to Unknown Historical Condition Pyelocystitis (Pyelocystitis) V. MANUFACTURER INFORMATION 24a. NAME AND ADDRESS OF MANUFACTURER Novartis Pharma S. A. France 26. REMARKS World Wide #: IT-002147023-NVSC2022IT011983 24b. MFR CONTROL NOG. NVSC2022IT011983 25b. NAME AND ADDRESS OF REPORTER NAME AND ADDRESS WITHHELD. 24垄. DATE RECEIVED NAME AND ADDRESS WITHHELD. BY MANUFACTURER 04-MAR-2022 24d. REPORT SOURCE g STUDY g HEALTH PROFESSIONAL 25a. REPORT TYPE B mi Tia L D LITERATURE D OTHER: DATE OF THIS REPORT 10-MAR-2023 [Jro Lrowur: 10-Mar-2023 09:30 | Scanned_CIOMS_ocred.pdf |
Page 2 of 3 Mfr. Control Number: NVSC2022IT011983 ADDITIONAL INFORMATION 7+13. DESCRIBE REACTION(S) continued The subject's historical conditions included rib fracture (from 12 Feb 2021), pyelocystitis (from 2000}, pneumonitis (from 2000) and erysipelas (from 2019). Current conditions included rib fracture, basedow disease (since 1980), mitral valve disease (since 2002), cough (since 18 Mar 2021), prophylaxis for intermittent conjunctivitis and cough, cough prophylaxis, as heeded if pain and constipation prophylaxis. Concomitant medications included beclometasone dipropionate, cetirizine, paracetamol, ketoprofen lysine, Movicol (macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride), Symbicort (budesonide, formoterol fumarate) and levothyroxine. The subject was enrolled previously in study: CLXH254X2101 and received spartalizumab from 12 Nov 2019 to 17 Sep 2021 and LXH254 from 12 Nov 2019 to 14 Oct 2021. On 15 Oct 2021, the subject started study medication LXH254 LXH254+TAB (LXH254) tablet at a dose of 200 mg, BID (2 times per day) (oraly and study medication spartalizumab powder for solution for infusion at a dose of 400 mg, Q4W (every 4 weeks) (intravenous). On 18 Nov 2021, 1 month 4 days after the first dose of the study medication, the subject developed traumatic fracture of the head of the right humerus (humerus fracture). On 22 Nov 2021, subject was hospitalized to undergo a humerus surgery to reduce the fracture (for traumatic fracture of the head of the right humerus) and chest X-ray was normal and ECG (echocardiogram) was normal. The action taken with LXH254 and spartalizumab was not reported after the subject experienced humerus fracture. On 24 Nov 2021 (in 7 days), the subject completely recovered from humerus fracture and was discharged on same date. The diagnosis event humerus fracture (hospitalization) was considered serious by the investigator. The causality of humerus fracture with LXH254 and spartalizumab was reported as not suspected. Follow up report received on 02 Mar 2022: Updated the dosing details of LXH254. Follow up report received on 04 Mar 2022: Updated event (humerus fracture) onset date from 22 Nov 2022 to 18 Nov 2022. Updated event latency from 01 month 07 days to 01 month 03 days. Updated duration of the event from 07 days to 03 days. Listedness information:- 1. Product--> SPARTALIZUMAB, Event--> humerus fracture, Causality--> Not Suspected Sheet Name--> IB Listedness--> Unknown. 2. Product--> LXH254 LXH254+TAB, Event--> humerus fracture, Causality--> Not Suspected Sheet Name--> IB Listedness--> Unknown. Novartis Comment: 1 month and 4 days after the first dose of the study medication (LXH254 and spartalizumab), 65 year old female patient developed traumatic fracture of the head of the right humerus (humerus fracture) and hospitalized on the same date to undergo a humerus surgery to reduce the fracture (for traumatic fracture of the head of the right humerus). Novartis agrees with the investigators causality "not suspected" as an alternative explanation (accidental fall) for the reported event. 13. Lab Data # Date Test / Assessment / Notes Results Normal High / Low 1 22-NOV-2021 Chest X-ray Normal Significant 2 22-NOV-2021 Electrocardiogram Normal Significant 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION continued #5 ) MOVICOL (MACROGOL 3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE) ; 22-JAN-2020/ Unknown #7 ) BECLOMETASONE DIPROPIONATE (BECLOMETASONE DIPROPIONATE, NEOMYCIN) ; 09-DEC-2020/ Unknown 10-Mar-2023 09:30 | Scanned_CIOMS_ocred.pdf |
Page 3 of 3 Mfr. Control Number: NVSC2022IT011983 ADDITIONAL INFORMATION 23. OTHER RELEVANT HISTORY continued From/To Dates Type of History / Notes Description 2000 to Unknown Historical Condition Pneumonitis (Pneumonitis); 2002 to Ongoing Current Condition Mitral valve disease (Mitral valve disease); 2019 to Unknown Historical Condition Erysipelas (Erysipelas), Unknown to Ongoing Current Condition Rib fracture (Rib fracture), also historical condition on 12 Feb 2021 18-MAR-2021 to Ongoing Current Condition Cough (Cough), 22-NOV-2021 to 22-NOV-2021 Procedure Surgery (Surgery); Traumatic fracture of the head of the right humerus Unknown to Ongoing Current Condition Prophylaxis (Prophylaxis), Ceftrizine, cough prophylaxis for beclometasone Unknown to Ongoing Current Condition Pain (Pain); Unknown to Ongoing Current Condition Constipation prophylaxis (Constipation prophylaxis); movicol 10-Mar-2023 09:30 | Scanned_CIOMS_ocred.pdf |
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