{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"104"},{"groupId":"OG001","value":"108"},{"groupId":"OG002","value":"38"}]}],"title":"AEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"38"},{"groupId":"OG001","value":"67"},{"groupId":"OG002","value":"22"}]}],"title":"SAEs"}],"denoms":[{"counts":[{"groupId":"OG000","value":"104"},{"groupId":"OG001","value":"108"},{"groupId":"OG002","value":"38"}],"units":"Participants"}],"description":"An AE is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. SAE is any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above.","groups":[{"description":"Participants received platinum-containing anticancer treatment regimens (with or without pembrolizumab) at the study center as chosen by the treating investigator based on NSCLC histology. Participants with NSCLC of non-squamous histology received carboplatin + pemetrexed or cisplatin + pemetrexed or pembrolizumab + carboplatin + pemetrexed or pembrolizumab + cisplatin + pemetrexed. Participants with NSCLC of squamous histology received carboplatin or cisplatin + gemcitabine or carboplatin + paclitaxel/nab-paclitaxel + pembrolizumab until PD or for up to a maximum of 2 years.","id":"OG000","title":"Arm A: Treatment Period- SOC"},{"description":"Participants received pralsetinib, 400 mg, QD on Day 1 of each cycle until PD, PTAP, pralsetinib was no longer available, unacceptable toxicity, non-compliance, withdrawal of consent, closure of the study by the sponsor, or death, whichever occurred first (cycle length=21 days).","id":"OG001","title":"Arm B: Treatment Period- Pralsetinib"},{"description":"Participants with confirmed PD as confirmed by blinded independent central review (BICR) in Arm A crossed over to receive pralsetinib, 400 mg, orally, QD on Day 1 of each cycle until PD, PTAP, pralsetinib was no longer available, unacceptable toxicity or death, whichever occurred first (cycle length=21 days).","id":"OG002","title":"Arm C: Crossover Period- Pralsetinib"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Safety-evaluable population included all participants who receive any amount of any study drug.","reportingStatus":"POSTED","timeFrame":"Up to approximately 50 months","title":"Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)","type":"SECONDARY","unitOfMeasure":"Participants"}