TriangleNCT02499770 · CITED IN SOURCE DOCUMENTS
Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Combination With Etoposide and Carboplatin in Extensive Stage Small Cell Lung Cancer (SCLC)
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE1, PHASE2
- Status at capture
- COMPLETED
- Registry last update
- 2020-08-21
This is a study to investigate the potential clinical benefit of trilaciclib (G1T28) in preserving the bone marrow and the immune system, and enhancing chemotherapy antitumor efficacy when administered prior to carboplatin and etoposide in first line treatment for patients with newly diagnosed extensive-stage SCLC. The study consists of 2 parts: a limited open-label, dose-finding portion (Part 1), and a randomized double-blind portion (Part 2). Both parts include 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase begins on the day of first dose with study treatment and completes at the Post-Treatment Visit. Approximately, 90 patients will be enrolled in the study; 20 patients in the Part 1 and 70 patients in the Part 2 portion.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Number of Participants With Dose Limiting Toxicities by Cohort in Cycle 1, Part 1
Incidence of Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Related AEs, Related SAEs, and AEs Leading to Study Drug Discontinuation in Part 1
Duration of Severe (Grade 4) Neutropenia in Part 2
Maximum Observed Plasma Concentration (Cmax) of Trilaciclib in Cycle 1, Part 1
Area Under the Plasma Concentration Versus Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) for Trilaciclib in Cycle 1, Part 1
Time of Maximum Observed Concentration (Tmax) of Trilaciclib in Cycle 1, Part 1
Cmax of Etoposide and Free and Total Carboplatin in Cycle 1, Part 1
AUC0-inf of Etoposide and Free and Total Carboplatin in Cycle 1, Part 1
Tmax of Etoposide and Free and Total Carboplatin in Cycle 1, Part 1
Duration of Severe (Grade 4) Neutropenia in Part 1
Occurrence of Severe (Grade 4) Neutropenia in Part 1
Occurrence of Febrile Neutropenia in Part 1
Duration of Grade 3/4 Neutropenia in Part 1
Occurrence of Grade 3/4 Neutropenia in Part 1
Nadir of Absolute Neutrophil Count in Cycle 1, Part 1
Occurrence of Granulocyte-Colony Stimulating Factor (G-CSF) Administration in Part 1
Occurrence of Red Blood Cell (RBC) Transfusion in Part 1
Change From Baseline of Hemoglobin at the End of Cycle 6, Part 1
Occurrence of Erythropoietin Stimulating Agent (ESA) Administration in Part 1
Occurrence of Platelet Transfusion in Part 1
Change From Baseline of Platelet Count at the End of Cycle 6, Part 1
Change From Baseline of Lymphocyte Count at the End of Cycle 6, Part 1
Occurrence of Dose Reduction in Part 1
Occurrence of Infectious SAEs in Part 1
Occurrence of Pulmonary Infection SAE in Part 1
Occurrence of IV Antibiotic Administration in Part 1
Time to First Major Adverse Hematologic Event (MAHE) in Part 1
Best Overall Tumor Response Based on Assessments in Part 1
Best Overall Tumor Response Based on Blinded Independent Central Review (BICR) Assessments in Part 1
Progression Free Survival (PFS) Based on Assessments in Part 1
OS in Part 1
Occurrence of Severe (Grade 4) Neutropenia in Part 2
Occurrence of Febrile Neutropenia in Part 2
Duration of Grade 3/4 Neutropenia in Part 2
Occurrence of Grade 3/4 Neutropenia in Part 2
Nadir of Absolute Neutrophil Count in Cycle 1, Part 2
Occurrence of G-CSF Administration in Part 2
Occurrence of RBC Transfusion in Part 2
Change From Baseline of Hemoglobin at the End of Cycle 6, Part 2
Occurrence of ESA Administration in Part 2
Occurrence of Platelet Transfusion in Part 2
Change From Baseline of Platelet Count at the End of Cycle 6, Part 2
Change From Baseline of Lymphocyte Count at the End of Cycle 6, Part 2
Occurrence of Dose Reduction in Part 2
Occurrence of Infectious SAEs in Part 2
Occurrence of Pulmonary Infection SAE in Part 2
Occurrence of IV Antibiotic Administration in Part 2
Time to First MAHE in Part 2
Best Overall Tumor Response Based on Assessments in Part 2
Best Overall Tumor Response Based on BICR Assessments in Part 2
PFS Based on Assessments in Part 2
OS in Part 2
Duration of Severe (Grade 4) Neutropenia in Cycle 1 of Part 2
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- Inclusion Criteria: * Male or female subjects aged ≥18 years * Unequivocally confirmed diagnosis of SCLC by histology or cytology, preferably including the presence of neuroendocrine features by immunohistochemistry * At least 1 target lesion that is unirradiated and measurable by RECIST, Version 1.1 * Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2 * Adequate organ function Exclusion Criteria: * Prior chemotherapy for extensive-stage SCLC * Presence of symptomatic brain metastases requiring immediate treatment with radiation therapy or steroids. * Uncontrolled ischemic heart disease or uncontrolled symptomatic congestive heart failure * Known history of stroke or cerebrovascular accident within 6 months prior to enrollment * Other uncontrolled serious chronic disease or conditions that in the investigator's opinion could affect compliance or follow-up in the protocol * Concurrent radiotherapy to any site or radiotherapy within 2 weeks prior to enrollment or previous radiotherapy to the target lesion sites (the sites that are to be followed for determination of a response) * Receipt of any investigational medication within 4 weeks prior to enrollment
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- All patients in part 1 will receive trilaciclib (G1T28) prior to standard chemotherapy- carboplatin and etoposide. Patients will have PK assessments completed on days 1 and 3 in cycle 1 only. All patents will be monitored for safety and tumor response based on RECIST version 1.1. Safety surveillance reporting of AEs and concomitant medications commences at the time that informed consent is obtained and continues through the Post Treatment Visit.
- intervention Names
- Drug: Carboplatin
- Drug: Trilaciclib
- Drug: Etoposide
- label
- trilaciclib + carboplatin/etoposide
- type
- EXPERIMENTAL
- description
- All patients enrolled in part 2 will be randomized to receive either trilaciclib (G1T28) or placebo administered prior to standard chemotherapy- carboplatin and etoposide. All patents will be monitored for safety and tumor response based on RECIST version 1.1. Safety surveillance reporting of AEs and concomitant medications commences at the time that informed consent is obtained and continues through the Post Treatment Visit.
- intervention Names
- Drug: Carboplatin
- Drug: Placebo
- Drug: Trilaciclib
- Drug: Etoposide
- label
- trilaciclib/placebo + carboplatin/etoposide
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- trilaciclib + carboplatin/etoposide
- trilaciclib/placebo + carboplatin/etoposide
- name
- Carboplatin
- other Names
- Paraplatin
- type
- DRUG
- arm Group Labels
- trilaciclib/placebo + carboplatin/etoposide
- name
- Placebo
- type
- DRUG
- arm Group Labels
- trilaciclib + carboplatin/etoposide
- trilaciclib/placebo + carboplatin/etoposide
- name
- Trilaciclib
- other Names
- G1T28
- type
- DRUG
- arm Group Labels
- trilaciclib + carboplatin/etoposide
- trilaciclib/placebo + carboplatin/etoposide
- name
- Etoposide
- other Names
- VP-16
- Toposar
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- DOUBLE
- who Masked
- PARTICIPANT
- INVESTIGATOR
- primary Purpose
- TREATMENT
Enrollment
- count
- 122
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- Dose-limiting toxicities (DLTs) were drug-related toxicities defined as follows: 1. Absolute neutrophil count (ANC) \< 0.5 × 10\^9/L lasting for ≥ 7 days 2. ≥ Grade 3 neutropenic infection/febrile neutropenia 3. Grade 4 thrombocytopenia (TCP) or ≥ Grade 3 TCP with bleeding 4. Unable to start next cycle of chemotherapy due to lack of recovery to an ANC ≥ 1.5 × 10\^9/L and platelet count ≥ 100 × 10\^9/L 5. ≥ Grade 3 nonhematologic toxicity (nausea, vomiting, and diarrhea failing maximal medical management; fatigue lasting for \> 72 hours) Toxicities not clearly related to etoposide/carboplatin therapy were also considered for the purposes of determining DLTs.
- measure
- Number of Participants With Dose Limiting Toxicities by Cohort in Cycle 1, Part 1
- time Frame
- Days 1-21 of Cycle 1
- description
- An AE was defined as any untoward medical occurrence in a participant administered a medicinal product that did not necessarily have a causal relationship with this treatment. TEAEs were defined as any AE that started on or after the first dose of study drug and up to the last dose +30 days. SAEs were defined as any untoward medical occurrence that at any dose resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity or was a congenital anomaly/birth defect. Relatedness to study drug was assessed by the investigator. Related refers to those events that were Possibly, Probably, or Definitely Related. AEs with an unknown/not reported onset date were also included.
- measure
- Incidence of Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Related AEs, Related SAEs, and AEs Leading to Study Drug Discontinuation in Part 1
- time Frame
- TEAEs were any AE that started on or after the first dose of study drug and up to the last dose +30 days (a minimum of 51 days up to a maximum of 374 days)
- description
- Severe (Grade 4) neutropenia was defined as at least 1 ANC value \<0.5 × 10\^9/L during the treatment period. Within each cycle, the duration (days) of severe neutropenia was defined as the number of days from the date of the first ANC value of \<0.5 × 10\^9/L observed between start of cycle and end of cycle to the date of the first ANC value ≥0.5 × 10\^9/L that met the following criteria: 1) occurred after the ANC value of \<0.5 × 10\^9/L and 2) no other ANC values \<0.5 × 10\^9/L occurred between this day and end of cycle. The duration of severe neutropenia only included participants who had at least 1 severe neutropenia event in the cycle, and censoring rules were applied for unresolved severe neutropenia in a cycle. For the treatment period, the overall duration of severe neutropenia was the median value among the durations from all cycles.
- measure
- Duration of Severe (Grade 4) Neutropenia in Part 2
- time Frame
- From randomization to the end of the treatment period (a minimum of 51 days up to a maximum of 379 days)
- secondary Outcomes
- description
- Cmax of trilaciclib in plasma was determined from individual concentration-time data by non-compartmental analysis methods. The actual sampling times in relation to dosing were used. For estimation of Cmax, a concentration that was below the limit of quantification (BLQ) was assigned a value of zero if it occurred in a profile before the first measurable concentration. If a BLQ value occurred after a measurable concentration in a profile, and was followed by a value above the lower limit of quantification, then the BLQ was treated as missing data. If a BLQ value occurred at the end of the collection interval (after the last quantifiable concentration) it was treated as missing data. If two BLQ values occurred in succession after Cmax, the profile was deemed to have terminated at the first BLQ value and any subsequent concentrations were omitted.
- measure
- Maximum Observed Plasma Concentration (Cmax) of Trilaciclib in Cycle 1, Part 1
- time Frame
- Days 1 and 3 of Cycle 1 for a 21-day cycle
- description
- AUC0-inf of trilaciclib in plasma was determined from individual concentration-time data by non-compartmental analysis methods. The actual sampling times in relation to dosing were used.
- measure
- Area Under the Plasma Concentration Versus Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) for Trilaciclib in Cycle 1, Part 1
- time Frame
- Days 1 and 3 of Cycle 1 for a 21-day cycle
- description
- Tmax of trilaciclib in plasma was determined from individual concentration-time data by non-compartmental analysis methods. The actual sampling times in relation to dosing were used.
- measure
- Time of Maximum Observed Concentration (Tmax) of Trilaciclib in Cycle 1, Part 1
- time Frame
- Days 1 and 3 of Cycle 1 for a 21-day cycle
- description
- Cmax of etoposide and free and total carboplatin in plasma were determined from individual concentration-time data by non-compartmental analysis methods. The actual sampling times in relation to dosing were used. For estimation of Cmax, a concentration that was BLQ was assigned a value of zero if it occurred in a profile before the first measurable concentration. If a BLQ value occurred after a measurable concentration in a profile, and was followed by a value above the lower limit of quantification, then the BLQ was treated as missing data. If a BLQ value occurred at the end of the collection interval (after the last quantifiable concentration) it was treated as missing data. If two BLQ values occurred in succession after Cmax, the profile was deemed to have terminated at the first BLQ value and any subsequent concentrations were omitted.
- measure
- Cmax of Etoposide and Free and Total Carboplatin in Cycle 1, Part 1
- time Frame
- Days 1 and 3 of Cycle 1 for a 21-day cycle (carboplatin was only dosed on Day 1 so there are no Day 3 Cmax values)
- description
- AUC0-inf of etoposide and free and total carboplatin in plasma were determined from individual concentration-time data by non-compartmental analysis methods. The actual sampling times in relation to dosing were used.
- measure
- AUC0-inf of Etoposide and Free and Total Carboplatin in Cycle 1, Part 1
- time Frame
- Days 1 and 3 of Cycle 1 for a 21-day cycle (carboplatin was only dosed on Day 1 so there are no Day 3 AUC0-inf values)
- description
- Tmax of etoposide and free and total carboplatin in plasma was determined from individual concentration-time data by non-compartmental analysis methods. The actual sampling times in relation to dosing were used.
- measure
- Tmax of Etoposide and Free and Total Carboplatin in Cycle 1, Part 1
- time Frame
- Days 1 and 3 of Cycle 1 for a 21-day cycle (carboplatin was only dosed on Day 1 so there are no Day 3 Tmax values)
- description
- Severe (Grade 4) neutropenia was defined as at least 1 ANC value \<0.5 × 10\^9/L during the treatment period. Within each cycle, the duration (days) of severe neutropenia was defined as the number of days from the date of the first ANC value of \<0.5 × 10\^9/L observed between start of cycle and end of cycle to the date of the first ANC value ≥0.5 × 10\^9/L that met the following criteria: 1) occurred after the ANC value of \<0.5 × 10\^9/L and 2) no other ANC values \<0.5 × 10\^9/L occurred between this day and end of cycle. The duration of severe neutropenia only included participants who had at least 1 severe neutropenia event in the cycle, and censoring rules were applied for unresolved severe neutropenia in a cycle. For the treatment period, the overall duration of severe neutropenia was the median value among the durations from all cycles.
- measure
- Duration of Severe (Grade 4) Neutropenia in Part 1
- time Frame
- From randomization to the end of the treatment period (a minimum of 51 days up to a maximum of 379 days)
- description
- Severe (Grade 4) neutropenia was defined as at least 1 ANC value \<0.5 × 10\^9/L during the treatment period.
- measure
- Occurrence of Severe (Grade 4) Neutropenia in Part 1
- time Frame
- From randomization to the end of the treatment period (a minimum of 51 days up to a maximum of 379 days)
- description
- Each febrile neutropenia event (as defined by Common Terminology Criteria for Adverse Events \[CTCAE\]) was captured as an AE. The occurrence of febrile neutropenia was defined as at least 1 febrile neutropenia event during the treatment period. For the treatment period, the total number of febrile neutropenia events was the number of febrile neutropenia events with a unique start date.
- measure
- Occurrence of Febrile Neutropenia in Part 1
- time Frame
- From randomization to the end of the treatment period (a minimum of 51 days up to a maximum of 379 days)
- description
- Grade 3/4 neutropenia was defined as at least 1 ANC value \<1.0 × 10\^9/L during the treatment period. Within each cycle, duration (days) of Grade 3/4 neutropenia was defined as the number of days from the date of the first ANC value of \<1.0 × 10\^9/L observed between start of cycle and end of cycle to the date of the first ANC value ≥1.0 × 10\^9/L that met the following criteria: 1) occurred after the ANC value of \<1.0 × 10\^9/L and 2) no other ANC values \<1.0 × 10\^9/L occurred between this day and end of cycle. The duration of Grade 3/4 neutropenia only included participants who had at least 1 Grade 3/4 neutropenia event in the cycle, and censoring rules were applied for unresolved Grade 3/4 neutropenia in a cycle. For the treatment period, the overall duration of Grade 3/4 neutropenia was the median value among the durations of Grade 3/4 neutropenia from all cycles.
- measure
- Duration of Grade 3/4 Neutropenia in Part 1
- time Frame
- From randomization to the end of the treatment period (a minimum of 51 days up to a maximum of 379 days)
- description
- Grade 3/4 neutropenia was defined as at least 1 ANC value \<1.0 × 10\^9/L during the treatment period.
- measure
- Occurrence of Grade 3/4 Neutropenia in Part 1
- time Frame
- From randomization to the end of the treatment period (a minimum of 51 days up to a maximum of 379 days)
- description
- Cycle nadir was the lowest value for ANC that occurred between start of cycle and end of cycle and was less than the cycle baseline.
- measure
- Nadir of Absolute Neutrophil Count in Cycle 1, Part 1
- time Frame
- From baseline to the end of Cycle 1
Full study description
- brief Summary
- This is a study to investigate the potential clinical benefit of trilaciclib (G1T28) in preserving the bone marrow and the immune system, and enhancing chemotherapy antitumor efficacy when administered prior to carboplatin and etoposide in first line treatment for patients with newly diagnosed extensive-stage SCLC. The study consists of 2 parts: a limited open-label, dose-finding portion (Part 1), and a randomized double-blind portion (Part 2). Both parts include 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase begins on the day of first dose with study treatment and completes at the Post-Treatment Visit. Approximately, 90 patients will be enrolled in the study; 20 patients in the Part 1 and 70 patients in the Part 2 portion.
Source references
- references
- citation
- Marzano L, Darwich AS, Dan A, Tendler S, Lewensohn R, De Petris L, Raghothama J, Meijer S. Exploring the discrepancies between clinical trials and real-world data: A small-cell lung cancer study. Clin Transl Sci. 2024 Aug;17(8):e13909. doi: 10.1111/cts.13909.
- pmid
- 39113428
- type
- DERIVED
- citation
- Hussein M, Maglakelidze M, Richards DA, Sabatini M, Gersten TA, Lerro K, Sinielnikov I, Spira A, Pritchett Y, Antal JM, Malik R, Beck JT. Myeloprotective Effects of Trilaciclib Among Patients with Small Cell Lung Cancer at Increased Risk of Chemotherapy-Induced Myelosuppression: Pooled Results from Three Phase 2, Randomized, Double-Blind, Placebo-Controlled Studies. Cancer Manag Res. 2021 Aug 9;13:6207-6218. doi: 10.2147/CMAR.S313045. eCollection 2021.
- pmid
- 34408488
- type
- DERIVED
- citation
- Ferrarotto R, Anderson I, Medgyasszay B, Garcia-Campelo MR, Edenfield W, Feinstein TM, Johnson JM, Kalmadi S, Lammers PE, Sanchez-Hernandez A, Pritchett Y, Morris SR, Malik RK, Csoszi T. Trilaciclib prior to chemotherapy reduces the usage of supportive care interventions for chemotherapy-induced myelosuppression in patients with small cell lung cancer: Pooled analysis of three randomized phase 2 trials. Cancer Med. 2021 Sep;10(17):5748-5756. doi: 10.1002/cam4.4089. Epub 2021 Aug 18.
- pmid
- 34405547
- type
- DERIVED
- citation
- Li C, Hart L, Owonikoko TK, Aljumaily R, Rocha Lima CM, Conkling PR, Webb RT, Jotte RM, Schuster S, Edenfield WJ, Smith DA, Sale M, Roberts PJ, Malik RK, Sorrentino JA. Trilaciclib dose selection: an integrated pharmacokinetic and pharmacodynamic analysis of preclinical data and Phase Ib/IIa studies in patients with extensive-stage small cell lung cancer. Cancer Chemother Pharmacol. 2021 May;87(5):689-700. doi: 10.1007/s00280-021-04239-9. Epub 2021 Feb 17.
- pmid
- 33595690
- type
- DERIVED
- citation
- Lai AY, Sorrentino JA, Dragnev KH, Weiss JM, Owonikoko TK, Rytlewski JA, Hood J, Yang Z, Malik RK, Strum JC, Roberts PJ. CDK4/6 inhibition enhances antitumor efficacy of chemotherapy and immune checkpoint inhibitor combinations in preclinical models and enhances T-cell activation in patients with SCLC receiving chemotherapy. J Immunother Cancer. 2020 Oct;8(2):e000847. doi: 10.1136/jitc-2020-000847.
- pmid
- 33004541
- type
- DERIVED
- citation
- Weiss JM, Csoszi T, Maglakelidze M, Hoyer RJ, Beck JT, Domine Gomez M, Lowczak A, Aljumaily R, Rocha Lima CM, Boccia RV, Hanna W, Nikolinakos P, Chiu VK, Owonikoko TK, Schuster SR, Hussein MA, Richards DA, Sawrycki P, Bulat I, Hamm JT, Hart LL, Adler S, Antal JM, Lai AY, Sorrentino JA, Yang Z, Malik RK, Morris SR, Roberts PJ, Dragnev KH; G1T28-02 Study Group. Myelopreservation with the CDK4/6 inhibitor trilaciclib in patients with small-cell lung cancer receiving first-line chemotherapy: a phase Ib/randomized phase II trial. Ann Oncol. 2019 Oct 1;30(10):1613-1621. doi: 10.1093/annonc/mdz278.
- pmid
- 31504118
- type
- DERIVED
Source notices and limitations
Discovery and provenance
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- apy. Study 2: COSELA Prior to Etoposide and Carboplatin (E/P) Patients with newly diagnosed ES-SCLC not previously treated with chemotherapy Study 2 (G1T28-02; NCT02499770) was an international, randomized (1:1), double-blind, placebo-controlled study of COSELA or placebo administered prior to treatment with etoposide and carbopl
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- fd1c99c8-df20-4278-b963-603bb0c10715
- source string basis
- parsed_JSON_string_unmodified
- source string sha256
- 4c786f6c25d5b92db9a9c955f42754b531c0663e1b71c8bc45056113dfab0a22
- spl effective time
- 20240224
- spl set id
- 4b06922c-498d-4871-a037-84a44e6a6b6c
- release id
- ctgov-registry-7ad944f6deaf1f5cd6122126
- edge id
- nct-edge-f7d193d39ef97b967f76
- requested nct id
- NCT02499770
- primary nct id
- NCT02499770
- source kind
- fda_spl_label
- source record id
- 8b1ee2ee-7097-4ded-9755-ffac490337c1
- source file sha256
- 424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3
- payload sha256
- a9d1d3ab49f15e34f5dc59812256b873aca188f4873c03ada43c380cf41d4943
- payload
- application numbers
- NDA214200
- clinical indication matching status
- not_inferred
- end exclusive
- true
- id
- nct-edge-f7d193d39ef97b967f76
- link basis
- explicit_NCT_identifier_in_acquired_source
- nct id
- NCT02499770
- occurrences
- context exact
- apy. Study 2: COSELA Prior to Etoposide and Carboplatin (E/P) Patients with newly diagnosed ES-SCLC not previously treated with chemotherapy Study 2 (G1T28-02; NCT02499770) was an international, randomized (1:1), double-blind, placebo-controlled study of COSELA or placebo administered prior to treatment with etoposide and carbopl
- end
- 2692
- exact text
- NCT02499770
- start
- 2681
- offset unit
- unicode_code_points
- source file
- /tmp/cancer-full-research/indications/raw/labels-00500.json
- source file sha256
- 424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3
- source json pointer
- /results/14/adverse_reactions/0
- source kind
- fda_spl_label
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- 8b1ee2ee-7097-4ded-9755-ffac490337c1
- source string basis
- parsed_JSON_string_unmodified
- source string sha256
- 82504607cf48d6412c403cf9a072733e855f70af9acc3f196868e9dcb00a5865
- spl effective time
- 20250831
- spl set id
- b3179c19-78f3-4bf1-b73e-7f7638522ab1
Preserved source evidence · Not medical advice